510(k) · Cleared
ClearedSoteria.AI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omega Medical Imaging, LLC · OWB Interventional Fluoroscopic X-Ray System
Cleared on Nov 17, 2021 as substantially equivalent to K182834 (Omega Medical Imaging, LLC, 2019) after a 113-day review. Its family tree reaches back 10 generations to 1991. 1 later device descends from it.
- Decided
- Nov 17, 2021
- Review
- 113 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K912470 (1991). 26 ancestors in all, the oldest K860913 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK912470 Philips Diagnost 96Philips Medical Systems, Inc. · 1991 · Recalled
- 6 generations between
- 3 generations backK100102 CS-Series-FPOmega Medical Imaging, Inc. · 2010
- 2 generations backK121293 CS-Series-FP with 3030+OptionOmega Medical Imaging, LLC · 2012
- 1 generation backK182834 CS-series-FP with Optional ROI Accessory CA-100SOmega Medical Imaging, LLC · 2019
- This deviceK212336 Soteria.AIOmega Medical Imaging, LLC · 2021
- Descendant · cites it directly · 0 of its ownK242488 Soteria E-ViewOmega Medical Imaging, LLC · 2025
Show all 10 generations
- Root · 10 generations backK912470 Philips Diagnost 96Philips Medical Systems, Inc. · 1991 · Recalled
- 9 generations backK960266 Siregraph CFSiemens Medical Solutions USA, Inc. · 1996 · Recalled
- 8 generations backK970734 Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic…Siemens Medical Solutions USA, Inc. · 1997
- 7 generations backK992660 Urf Digital - OTSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 6 generations backK040675 Axiom Artis USiemens Medical Systems, Inc. · 2004 · Recalled
- 5 generations backK062647 E-View Fluoroscopy System, Model CS-50Omega Medical Imaging, Inc. · 2006
- 4 generations backK070834 CS-Series Fluoroscopy System, CS-10 Through CS-65 (11 Configurations)Omega Medical Imaging, Inc. · 2007
- 3 generations backK100102 CS-Series-FPOmega Medical Imaging, Inc. · 2010
- 2 generations backK121293 CS-Series-FP with 3030+OptionOmega Medical Imaging, LLC · 2012
- 1 generation backK182834 CS-series-FP with Optional ROI Accessory CA-100SOmega Medical Imaging, LLC · 2019
- This deviceK212336 Soteria.AIOmega Medical Imaging, LLC · 2021
Most influential descendants
Showing 1 of 1 · See all- K242488Soteria E-ViewOmega Medical Imaging, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K912470 | Philips Diagnost 96 | Philips Medical Systems, Inc. | 1991 | 9 |
| −9 | K960266 | Siregraph CF | Siemens Medical Solutions USA, Inc. | 1996 | 3 |
| −8 | K970734 | Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic X-Ray Systems | Siemens Medical Solutions USA, Inc. | 1997 | — |
| −7 | K992660 | Urf Digital - OT | Siemens Medical Solutions USA, Inc. | 1999 | 4 |
| −6 | K040675 | Axiom Artis U | Siemens Medical Systems, Inc. | 2004 | 1 |
| −5 | K062647 | E-View Fluoroscopy System, Model CS-50 | Omega Medical Imaging, Inc. | 2006 | — |
| −4 | K070834 | CS-Series Fluoroscopy System, CS-10 Through CS-65 (11 Configurations) | Omega Medical Imaging, Inc. | 2007 | — |
| −3 | K100102 | CS-Series-FP | Omega Medical Imaging, Inc. | 2010 | — |
| −2 | K121293 | CS-Series-FP with 3030+Option | Omega Medical Imaging, LLC | 2012 | — |
| −1 | K182834 | CS-series-FP with Optional ROI Accessory CA-100S | Omega Medical Imaging, LLC | 2019 | — |
| 0 (this device) | K212336 | Soteria.AI | Omega Medical Imaging, LLC | 2021 | — |
| +1 | K242488 | Soteria E-View | Omega Medical Imaging, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 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 18.2 · 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? (1)
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 |
|---|---|---|---|
| * | K182834 | CS-series-FP with Optional ROI Accessory CA-100SSummary page 5…Radiation Emitting Products (21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard) Predicate Device K182834 Company Name: Omega Medical Imaging, LLC Address: 675 Hickman Circle, Sanford, Florida 32771 Telep… | 2019 |
| † | K112807 | X-Ray Vva | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242488 | Soteria E-View | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 16 of the 26 ancestors have a recall of any class.
- Of its descendants, K242488 (Omega Medical Imaging, LLC, 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K182834.
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. 2021, 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?
The System is intended for use in Radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic and interventional x-ray imaging for General and Pediatric Populations
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212336 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212336: Soteria.AI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212336
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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