510(k) · Cleared
Recalled · Class II · 2025Artis One
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Apr 28, 2014 as substantially equivalent to K122644 (Siemens Medical Solutions USA, Inc., 2013) and 2 other predicates after a 158-day review. Its family tree reaches back 9 generations to 1980. 11 later devices descend from it. It has been recalled 7 times.
- Decided
- Apr 28, 2014
- Review
- 158 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 7
- Predicates
- 3
Its longest line of descent runs back 9 generations to K801623 (1980). 47 ancestors in all. 11 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 5 generations between
- 3 generations backK073290 Artis Zee and ZeegoSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 2 generations backK090745 Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc. · 2009 · Recalled
- 1 generation backK123529 Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- This deviceK133580 Artis OneSiemens Medical Solutions USA, Inc. · 2014
- Descendant · cites it directly · 10 of its ownK190768 ARTIS iconoSiemens Medical Solutions USA, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 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 · 3 generations on · 4 of its ownK220409 ARTIS pheno (VE21) SystemSiemens Medical Solutions USA, Inc. · 2022 · Recalled
- Descendant · 4 generations on · 3 of its ownK230949 ARTIS pheno (VE30A)Siemens Medical Solutions USA, Inc. · 2023 · Recalled
Show all 9 generations
- Root · 9 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 8 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 7 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 6 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 5 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 4 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 3 generations backK073290 Artis Zee and ZeegoSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 2 generations backK090745 Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc. · 2009 · Recalled
- 1 generation backK123529 Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- This deviceK133580 Artis OneSiemens Medical Solutions USA, Inc. · 2014
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K190768ARTIS iconoSiemens Medical Solutions USA, Inc. · 2019 · cites it directly10descendants
- K201156ARTIS pheno (VE2)Siemens Medical Solution USA, Inc. · 2020 · 2 generations on5descendants
- K220432ARTIS icono (VE21) SystemSiemens Medical Solutions USA, Inc. · 2022 · 2 generations on4descendants
- K220409ARTIS pheno (VE21) SystemSiemens Medical Solutions USA, Inc. · 2022 · 3 generations on4descendants
- K230949ARTIS pheno (VE30A)Siemens Medical Solutions USA, Inc. · 2023 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −8 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −7 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −6 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −5 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −4 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −3 | K073290 | Artis Zee and Zeego | Siemens Medical Solutions USA, Inc. | 2008 | 39 |
| −2 | K090745 | Artis Zee / Zeegos with SW VC14 | Siemens Medical Solutions USA, Inc. | 2009 | 7 |
| −1 | K123529 | Artis Q and Q.Zen- Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2013 | 31 |
| 0 (this device) | K133580 | Artis One | Siemens Medical Solutions USA, Inc. | 2014 | — |
| +1 | K190768 | ARTIS icono | Siemens Medical Solutions USA, Inc. | 2019 | 4 |
| +2 | K201156 | ARTIS pheno (VE2) | Siemens Medical Solution USA, Inc. | 2020 | 6 |
| +2 | K220432 | ARTIS icono (VE21) System | Siemens Medical Solutions USA, Inc. | 2022 | 4 |
| +3 | K220409 | ARTIS pheno (VE21) System | Siemens Medical Solutions USA, Inc. | 2022 | 2 |
| +4 | 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 | 2 | 0 |
| 2002 | 3 | 0 |
| 2004 | 4 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K122644 | Artis Zee/Zeego with CSX-10 Detector SW VC21Summary page 2…ted Predicate Devices Trade Name: Artis zee/ zeego with CSX-10 Detector SW VC21 510(k) Clearance: K122644 Clearance Date: May 20, 2013 Classification Name: Image intensified fluoroscopic x-ray… | 2013 |
| * | K123529 | Artis Q and Q.Zen- Modular Angiographic SystemSummary page 2…OWB Trade Name: Arts Q and Q.zen - Modular Angiographic System 510(k) Clearance: K1 23529 Clearance Date: February 26, 2013 Classification Name: Angiographic X-Ray System… | 2013 |
| * | K042995 | X-LeonardoSummary page 2…Class 11 Product Code: OWBT JAA, IZI Trade Name: X-LEONARDO Workstation 510(k) Clearance: K042995 Clearance Date: November 24, 2004 Classification Name: Picture archiving and communications… | 2004 |
What descends from it? (11)
See all 112 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 |
|---|---|---|---|---|
| Jan 2, 2025 | Class II | Z-0922-2025 | Radiation Control for Health and Safety Act | A potential issue with ARTIS One systems was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied… |
| Mar 21, 2023 | Class II | Z-1469-2023 | Device Design | Examination room monitor connected with the hybrid cable may have a display issue and no image function is available |
| Sep 21, 2020 | Class II | Z-0298-2021 | Component design/selection | Potential malfunction in which the examination room monitor may become intermittently dysfunctional (e.g., no display/flicking/wrong resolution). |
| Jan 12, 2018 | Class II | Z-1148-2018 | Process control | Certain patient table systems may have a missing or incorrectly installed snap ring that could cause the bolt to slide out of its base and the tabletop carriage to slide to the floor. |
| Aug 22, 2017 | Class II | Z-0614-2018 | Nonconforming Material/Component | The possibility exists for the monitor display of Artis one systems with a DP Transceiver below revision 03 to experience blinking and/or a blue/black screen |
| Mar 11, 2016 | Class II | Z-1282-2016 | Software in the Use Environment | After importing segmentation results of the left atrium created on the Artis One system, the possibility exists for the results to be mirrored to an electro-anatomical 3D mapping system, CARTO from Biosense Webster Inc. |
| Jan 16, 2015 | Class II | Z-1119-2015 | Process control | The possibility exists that the monitor may fail and requires a power circle (shutdown and then power on) to resume operation. The problem is not systematic; but sporadic on single units. |
The 5 latest of 7 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 34 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 12 of the 47 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.
- 3 other devices also cite its predicate K122644.
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. 2014, this device’s year, is highlighted.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 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 one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis one 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.…
Read the full statement (117 words)
Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Procedures that can be performed with the Artis one 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.
The Artis one can also support the acquisition of position triggered imaging for spatial data synthesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133580 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133580: Artis One.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133580
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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