510(k) · Cleared
Recalled · Class II · 2026ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)
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 Oct 22, 2024 as substantially equivalent to K230950 (Siemens Medical Solutions USA, Inc., 2023) and 2 other predicates after a 144-day review. Its family tree reaches back 15 generations to 1980. 2 later devices descend from it. It has been recalled 11 times.
- Decided
- Oct 22, 2024
- Review
- 144 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 11
- Predicates
- 3
Its longest line of descent runs back 15 generations to K801623 (1980). 61 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 11 generations between
- 3 generations backK201156 ARTIS pheno (VE2)Siemens Medical Solution USA, Inc. · 2020 · Recalled
- 2 generations backK220409 ARTIS pheno (VE21) SystemSiemens Medical Solutions USA, Inc. · 2022 · Recalled
- 1 generation backK230949 ARTIS pheno (VE30A)Siemens Medical Solutions USA, Inc. · 2023 · Recalled
- This deviceK241572 ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS…Siemens Medical Solutions USA, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK254173 ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS…Siemens Medical Solutions USA, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK253752 ARTIS genio floor; ARTIS icono.explore floorSiemens Medical Solutions USA, Inc. · 2026
Show all 15 generations
- Root · 15 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 14 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 13 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 12 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 11 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 10 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 9 generations backK073290 Artis Zee and ZeegoSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 8 generations backK090745 Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc. · 2009 · Recalled
- 7 generations backK123529 Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- 6 generations backK141574 Artis Zee/Zeego SW VC21Siemens Medical Solutions USA, Inc. · 2014 · Recalled
- 5 generations backK181407 Artis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc. · 2018 · Recalled
- 4 generations backK190768 ARTIS iconoSiemens Medical Solutions USA, Inc. · 2019 · Recalled
- 3 generations backK201156 ARTIS pheno (VE2)Siemens Medical Solution USA, Inc. · 2020 · Recalled
- 2 generations backK220409 ARTIS pheno (VE21) SystemSiemens Medical Solutions USA, Inc. · 2022 · Recalled
- 1 generation backK230949 ARTIS pheno (VE30A)Siemens Medical Solutions USA, Inc. · 2023 · Recalled
- This deviceK241572 ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS…Siemens Medical Solutions USA, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −14 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −13 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −12 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −11 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −10 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −9 | K073290 | Artis Zee and Zeego | Siemens Medical Solutions USA, Inc. | 2008 | 39 |
| −8 | K090745 | Artis Zee / Zeegos with SW VC14 | Siemens Medical Solutions USA, Inc. | 2009 | 7 |
| −7 | K123529 | Artis Q and Q.Zen- Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2013 | 31 |
| −6 | K141574 | Artis Zee/Zeego SW VC21 | Siemens Medical Solutions USA, Inc. | 2014 | 12 |
| −5 | K181407 | Artis zee/zeego & Artis Q/Q.zen | Siemens Medical Solution USA, Inc. | 2018 | 59 |
| −4 | K190768 | ARTIS icono | Siemens Medical Solutions USA, Inc. | 2019 | 4 |
| −3 | K201156 | ARTIS pheno (VE2) | Siemens Medical Solution USA, Inc. | 2020 | 6 |
| −2 | K220409 | ARTIS pheno (VE21) System | Siemens Medical Solutions USA, Inc. | 2022 | 2 |
| −1 | K230949 | ARTIS pheno (VE30A) | Siemens Medical Solutions USA, Inc. | 2023 | 2 |
| 0 (this device) | K241572 | ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono… | Siemens Medical Solutions USA, Inc. | 2024 | — |
| +1 | K254173 | ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno | Siemens Medical Solutions USA, Inc. | 2026 | — |
| +1 | K253752 | ARTIS genio floor; ARTIS icono.explore floor | Siemens Medical Solutions USA, Inc. | 2026 | — |
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 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K230950 | ARTIS icono (VE30A)Summary page 6…Codes: IZI, JAA, JAK 4. Legally Marketed Primary Predicate Device Trade Name: ARTIS icono (VE30A) 510(k) Clearance K230950 Clearance Date December 14, 2023 Classification Name: Image-intensified fluoroscopic X-ray Sys… | 2023 |
| * | K221516 | ARTIS icono (Ceiling Configuration)Summary page 6…applicable issues. Secondary Predicate Device Trade Name: ARTIS icono (VE23) System 510(k) Clearance K221516 Clearance Date July 19, 2022 Classification Name: Image-intensified fluoroscopic X-ray Sy… | 2022 |
| * | K230949 | ARTIS pheno (VE30A)Summary page 6…issues. Secondary Predicate Device Trade Name: ARTIS pheno (VE30A) 510(k) Clearance K230949 Clearance Date December 15, 2023 Classification Name: Image-intensified fluoroscopic X-ra… | 2023 |
What descends from it? (2)
2 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 |
|---|---|---|---|---|
| May 20, 2026 | Class II | Z-2643-2026 | Software design | Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits. |
| May 20, 2026 | Class II | Z-2642-2026 | Software design | Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits. |
| May 20, 2026 | Class II | Z-2641-2026 | Software design | Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits. |
| Mar 12, 2026 | Class II | Z-1814-2026 | Radiation Control for Health and Safety Act | During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of… |
| Mar 10, 2026 | Class II | Z-1653-2026 | Radiation Control for Health and Safety Act | During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance… |
| Mar 9, 2026 | Class II | Z-2206-2026 | Radiation Control for Health and Safety Act | During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing… |
| Mar 9, 2026 | Class II | Z-2205-2026 | Radiation Control for Health and Safety Act | During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing… |
| Aug 12, 2025 | Class II | Z-2529-2025 | Software design | Limited system movements after startup . |
| May 15, 2025 | Class II | Z-2021-2025 | Radiation Control for Health and Safety Act | In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose. |
| May 15, 2025 | Class II | Z-2022-2025 | Radiation Control for Health and Safety Act | In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose. |
| May 15, 2025 | Class II | Z-2020-2025 | Radiation Control for Health and Safety Act | In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose. |
The 5 latest of 11 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 44 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 24 of the 61 ancestors have a recall of any class.
- Of its descendants, K254173 (Siemens Medical Solutions USA, Inc., 2026) has gone furthest, with 0 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. 2024, 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 is a family of dedicated angiography systems developed for single plane 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…
Read the full statement (195 words)
ARTIS is a family of dedicated angiography systems developed for single plane 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. This does not include projection radiography.
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 systems can also support the acquisition of position triggered imaging for spatial data synthesis.
The ARTIS systems include also the software option DynaCT with following indications for use:
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/K241572 · printed Nov 4, 2026
Cite this page
510(k) Report. “K241572: ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K241572
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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