510(k) · Cleared
Recalled · Class II · 2024Artis zee/zeego & Artis Q/Q.zen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solution USA, Inc. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Aug 15, 2018 as substantially equivalent to K141574 (Siemens Medical Solutions USA, Inc., 2014) and 1 other predicate after a 77-day review. Its family tree reaches back 10 generations to 1980. 13 later devices descend from it. It has been recalled 59 times.
- Decided
- Aug 15, 2018
- Review
- 77 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 59
- Predicates
- 2
Its longest line of descent runs back 10 generations to K801623 (1980). 45 ancestors in all. 13 later devices descend from it, 6 citing it directly.
- Root · 10 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 6 generations between
- 3 generations backK090745 Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc. · 2009 · Recalled
- 2 generations backK123529 Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- 1 generation backK141574 Artis Zee/Zeego SW VC21Siemens Medical Solutions USA, Inc. · 2014 · Recalled
- This deviceK181407 Artis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc. · 2018
- Descendant · cites it directly · 10 of its ownK190768 ARTIS iconoSiemens Medical Solutions USA, Inc. · 2019 · Recalled
- Descendant · cites it directly · 5 of its ownK201156 ARTIS pheno (VE2)Siemens Medical Solution USA, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 4 of its ownK220432 ARTIS icono (VE21) SystemSiemens Medical Solutions USA, Inc. · 2022 · Recalled
- Descendant · 2 generations on · 4 of its ownK220409 ARTIS pheno (VE21) SystemSiemens Medical Solutions USA, Inc. · 2022 · Recalled
- Descendant · 3 generations on · 3 of its ownK230949 ARTIS pheno (VE30A)Siemens Medical Solutions USA, Inc. · 2023 · Recalled
Show all 10 generations
- Root · 10 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 9 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 8 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 7 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 6 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 5 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 4 generations backK073290 Artis Zee and ZeegoSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 3 generations backK090745 Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc. · 2009 · Recalled
- 2 generations backK123529 Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- 1 generation backK141574 Artis Zee/Zeego SW VC21Siemens Medical Solutions USA, Inc. · 2014 · Recalled
- This deviceK181407 Artis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc. · 2018
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
2019high 3 (2020) · low 0 (2021)2026
Most influential descendants
Showing 5 of 13 · See all- K190768ARTIS iconoSiemens Medical Solutions USA, Inc. · 2019 · cites it directly10descendants
- K201156ARTIS pheno (VE2)Siemens Medical Solution USA, Inc. · 2020 · cites it directly5descendants
- K220432ARTIS icono (VE21) SystemSiemens Medical Solutions USA, Inc. · 2022 · 2 generations on4descendants
- K220409ARTIS pheno (VE21) SystemSiemens Medical Solutions USA, Inc. · 2022 · 2 generations on4descendants
- K230949ARTIS pheno (VE30A)Siemens Medical Solutions USA, Inc. · 2023 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −9 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −8 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −7 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −6 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −5 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −4 | K073290 | Artis Zee and Zeego | Siemens Medical Solutions USA, Inc. | 2008 | 39 |
| −3 | K090745 | Artis Zee / Zeegos with SW VC14 | Siemens Medical Solutions USA, Inc. | 2009 | 7 |
| −2 | K123529 | Artis Q and Q.Zen- Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2013 | 31 |
| −1 | K141574 | Artis Zee/Zeego SW VC21 | Siemens Medical Solutions USA, Inc. | 2014 | 12 |
| 0 (this device) | K181407 | Artis zee/zeego & Artis Q/Q.zen | Siemens Medical Solution USA, Inc. | 2018 | — |
| +1 | K190768 | ARTIS icono | Siemens Medical Solutions USA, Inc. | 2019 | 4 |
| +1 | K201156 | ARTIS pheno (VE2) | Siemens Medical Solution USA, Inc. | 2020 | 6 |
| +2 | K220432 | ARTIS icono (VE21) System | Siemens Medical Solutions USA, Inc. | 2022 | 4 |
| +2 | K220409 | ARTIS pheno (VE21) System | Siemens Medical Solutions USA, Inc. | 2022 | 2 |
| +3 | K230949 | ARTIS pheno (VE30A) | Siemens Medical Solutions USA, Inc. | 2023 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 10 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2004 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OWB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K141574 | Artis Zee/Zeego SW VC21Summary page 5…WB, JAA, IZI 4. Legally Marketed Primary Predicate Device Trade Name: Artis zee/zeego SW VC21 510(k) Clearance K141574 Clearance Date September 05, 2014 Classification Name: Image-intensified fluoroscopic… | 2014 |
| * | K123529 | Artis Q and Q.Zen- Modular Angiographic SystemSummary page 5…issues. Legally Marketed Secondary Predicate Device Trade Name: Artis Q and Artis Q.zen 510(k) Clearance K123529 Clearance Date February 26, 2013 Classification Name: Image-intensified fluoroscopic x-… | 2013 |
What descends from it? (13)
See all 136 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 21, 2024 | Class II | Z-1598-2024 | Device Design | Coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message TUBE HOT, have a break . the system cannot… |
| Dec 16, 2022 | Class II | Z-1040-2023 | Software design | In rare cases, the system may only boot into backup mode after an abrupt shutdown and not reach full operating mode. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an… |
| Aug 10, 2022 | Class II | Z-1645-2022 | Device Design | Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to… |
| May 24, 2022 | Class II | Z-1343-2022 | Component design/selection | It may occur that after system startup no stand movement is possible any longer in the event of a discharged BIOS battery of the robotic stand control PC. If this problem occurs during startup, all stand movements are blocked and can only… |
| Feb 23, 2022 | Class II | Z-0972-2022 | Device Design | If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several… |
| Feb 23, 2022 | Class II | Z-0971-2022 | Device Design | If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several… |
| Feb 23, 2022 | Class II | Z-0976-2022 | Device Design | If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several… |
| Feb 23, 2022 | Class II | Z-0979-2022 | Device Design | If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several… |
| Feb 23, 2022 | Class II | Z-0968-2022 | Device Design | If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several… |
| Feb 23, 2022 | Class II | Z-0975-2022 | Device Design | If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several… |
| Feb 23, 2022 | Class II | Z-0969-2022 | Device Design | If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several… |
| Feb 23, 2022 | Class II | Z-0970-2022 | Device Design | If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several… |
| Feb 23, 2022 | Class II | Z-0974-2022 | Device Design | If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several… |
| Feb 23, 2022 | Class II | Z-0973-2022 | Device Design | If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several… |
| Feb 23, 2022 | Class II | Z-0980-2022 | Device Design | If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several… |
| Feb 23, 2022 | Class II | Z-0967-2022 | Device Design | If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several… |
| Feb 23, 2022 | Class II | Z-0977-2022 | Device Design | If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several… |
| Feb 23, 2022 | Class II | Z-0978-2022 | Device Design | If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several… |
| Oct 20, 2021 | Class II | Z-0305-2022 | Software design | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure |
| Oct 20, 2021 | Class II | Z-0299-2022 | Software design | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure |
| Oct 20, 2021 | Class II | Z-0296-2022 | Software design | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure |
| Oct 20, 2021 | Class II | Z-0297-2022 | Software design | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure |
| Oct 20, 2021 | Class II | Z-0302-2022 | Software design | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure |
| Oct 20, 2021 | Class II | Z-0300-2022 | Software design | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure |
| Oct 20, 2021 | Class II | Z-0301-2022 | Software design | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure |
| Oct 20, 2021 | Class II | Z-0303-2022 | Software design | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure |
| Oct 20, 2021 | Class II | Z-0298-2022 | Software design | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure |
| Oct 20, 2021 | Class II | Z-0304-2022 | Software design | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure |
| Sep 24, 2021 | Class II | Z-0200-2022 | Software design | Software error, the software can produce an incorrect interpretation of the table rotation if the table has been rotated by more than 4degrees in either direction. This can cause the 3D image reconstruction to be shown rotated by up to 5… |
| Jun 30, 2021 | Class II | Z-2404-2021 | Software design | Due to a software error, the IAS (Image Acquisition System) may sporadically fail during startup/ restart, and result in delay of clinical treatment |
| Mar 30, 2021 | Class II | Z-1496-2021 | Equipment maintenance | Due to inappropriate cleaning, some Artis systems show unexpected corrosion of visible belts which are needed to move system parts (e.g. C-Arm), Increased corrosion may lead to a malfunction of the belts which may result in limited… |
| Mar 26, 2021 | Class II | Z-1495-2021 | Device Design | Some Artis zee ceiling systems show an increased abrasion of the cabling at the cable outlet of the inner C-arm, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where… |
| Nov 30, 2020 | Class II | Z-0656-2021 | Software design | When the user changes frame rates from lower frequency (e.g. 10 f/s) to higher frequency (e.g. 30 f/s) during continuous release of Fluoro "Fluoro Override", the measured Air Kerma Rate can exceed the regulatory limits. |
| Oct 21, 2020 | Class II | Z-0469-2021 | Employee error | Some electronic components within the generator were equipped with an incorrect protection diode. As a result, protection against overvoltage may be inadequate, and the system may not function properly in the event an overvoltage… |
| Aug 3, 2020 | Class II | Z-0108-2021 | Software Manufacturing/Software Deployment | Potential exists for the collision supervision not to work properly following loss of the individual room configuration data settings causing danger of collision with fix mounted room equipment, walls or floor may occur. This might cause… |
| Apr 30, 2020 | Class II | Z-2302-2020 | Nonconforming Material/Component | Artis systems containing a Multi Display Manager of a specific lot, the power distributor may lead to an increased electrical contact resistance or the interruption of electrical contact, and result in planned procedures to be terminated… |
| Feb 14, 2020 | Class II | Z-1495-2020 | Software design | A software issue could potentially cause the stand and table movements to be blocked. |
| Feb 14, 2020 | Class II | Z-1496-2020 | Software design | A software issue could potentially cause the stand and table movements to be blocked. |
| Feb 14, 2020 | Class II | Z-1497-2020 | Software design | A software issue could potentially cause the stand and table movements to be blocked. |
| Nov 14, 2019 | Class II | Z-0695-2020 | Software design | In affected Artis zee floor Interventional Fluoroscopic X-Ray Systems, the activation of a collision sensor will cause a block the movement of the floating tabletop and could result in a delay or interruption of a procedure. |
| Jul 30, 2019 | Class II | Z-2367-2019 | Process control | Artis zee/Q systems patient tables may potentially have cracks in the table mainframe, and cause mechanical detachment of the upper part of the patient bed and lead to hazardous situations for patients and medical personnel due to falling… |
| Jun 12, 2019 | Class II | Z-2033-2019 | Component design/selection | A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue… |
| Jun 12, 2019 | Class II | Z-2030-2019 | Component design/selection | A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue… |
| Jun 12, 2019 | Class II | Z-2034-2019 | Component design/selection | A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue… |
| Jun 12, 2019 | Class II | Z-2029-2019 | Component design/selection | A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue… |
| Jun 12, 2019 | Class II | Z-2028-2019 | Component design/selection | A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue… |
| Jun 12, 2019 | Class II | Z-2031-2019 | Component design/selection | A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue… |
| Jun 12, 2019 | Class II | Z-2032-2019 | Component design/selection | A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue… |
| Jun 6, 2019 | Class II | Z-1903-2019 | Device Design | Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work… |
| Jun 6, 2019 | Class II | Z-1896-2019 | Device Design | Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work… |
The 5 latest of 50 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 38 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 11 of the 45 ancestors have a recall of any class.
- Of its descendants, K190768 (Siemens Medical Solutions USA, Inc., 2019) has gone furthest, with 10 descendants of its own.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · OWB
22in 2025
2007high 24 (2021) · low 3 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
2007high 221 (2026) · low 37 (2012)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
2007high 42 (2026) · low 0 (2007)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
2007high 14,008 (2025) · low 0 (2008)2025
MAUDE reports naming product code OWB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis family include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table…
Read the full statement (184 words)
Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Procedures that can be performed with the Artis family include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities.
Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions.
Artis can also support the acquisition of position triggered imaging for spatial data synthesis.
The Artis systems include also the software option DynaCT with following IFU:
DynaCT is an x-ray imaging software option, which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format.
DynaCT is intended for imaging both hard and soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures and treatment follow-up.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181407 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181407: Artis zee/zeego & Artis Q/Q.zen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181407
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026