510(k) · Cleared
ClearedSoteria E-View
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omega Medical Imaging, LLC · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Cleared on Jan 6, 2025 as substantially equivalent to K212336 (Omega Medical Imaging, LLC, 2021) after a 138-day review. Its family tree reaches back 11 generations to 1991.
- Decided
- Jan 6, 2025
- Review
- 138 days
- Class
- Class II
- Product code
- JAA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K912470 (1991). 27 ancestors in all, the oldest K860913 (1986). No later device cites it as a predicate yet.
- Root · 11 generations backK912470 Philips Diagnost 96Philips Medical Systems, Inc. · 1991 · Recalled
- 7 generations between
- 3 generations backK121293 CS-Series-FP with 3030+OptionOmega Medical Imaging, LLC · 2012
- 2 generations backK182834 CS-series-FP with Optional ROI Accessory CA-100SOmega Medical Imaging, LLC · 2019
- 1 generation backK212336 Soteria.AIOmega Medical Imaging, LLC · 2021
- This deviceK242488 Soteria E-ViewOmega Medical Imaging, LLC · 2025
Show all 11 generations
- Root · 11 generations backK912470 Philips Diagnost 96Philips Medical Systems, Inc. · 1991 · Recalled
- 10 generations backK960266 Siregraph CFSiemens Medical Solutions USA, Inc. · 1996 · Recalled
- 9 generations backK970734 Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic…Siemens Medical Solutions USA, Inc. · 1997
- 8 generations backK992660 Urf Digital - OTSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 7 generations backK040675 Axiom Artis USiemens Medical Systems, Inc. · 2004 · Recalled
- 6 generations backK062647 E-View Fluoroscopy System, Model CS-50Omega Medical Imaging, Inc. · 2006
- 5 generations backK070834 CS-Series Fluoroscopy System, CS-10 Through CS-65 (11 Configurations)Omega Medical Imaging, Inc. · 2007
- 4 generations backK100102 CS-Series-FPOmega Medical Imaging, Inc. · 2010
- 3 generations backK121293 CS-Series-FP with 3030+OptionOmega Medical Imaging, LLC · 2012
- 2 generations backK182834 CS-series-FP with Optional ROI Accessory CA-100SOmega Medical Imaging, LLC · 2019
- 1 generation backK212336 Soteria.AIOmega Medical Imaging, LLC · 2021
- This deviceK242488 Soteria E-ViewOmega Medical Imaging, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K912470 | Philips Diagnost 96 | Philips Medical Systems, Inc. | 1991 | 9 |
| −10 | K960266 | Siregraph CF | Siemens Medical Solutions USA, Inc. | 1996 | 3 |
| −9 | K970734 | Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic X-Ray Systems | Siemens Medical Solutions USA, Inc. | 1997 | — |
| −8 | K992660 | Urf Digital - OT | Siemens Medical Solutions USA, Inc. | 1999 | 4 |
| −7 | K040675 | Axiom Artis U | Siemens Medical Systems, Inc. | 2004 | 1 |
| −6 | K062647 | E-View Fluoroscopy System, Model CS-50 | Omega Medical Imaging, Inc. | 2006 | — |
| −5 | K070834 | CS-Series Fluoroscopy System, CS-10 Through CS-65 (11 Configurations) | Omega Medical Imaging, Inc. | 2007 | — |
| −4 | K100102 | CS-Series-FP | Omega Medical Imaging, Inc. | 2010 | — |
| −3 | K121293 | CS-Series-FP with 3030+Option | Omega Medical Imaging, LLC | 2012 | — |
| −2 | K182834 | CS-series-FP with Optional ROI Accessory CA-100S | Omega Medical Imaging, LLC | 2019 | — |
| −1 | K212336 | Soteria.AI | Omega Medical Imaging, LLC | 2021 | — |
| 0 (this device) | 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 |
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 JAA? 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 JAA device
- #1 K253103 Nexus DRF Digital X-ray Imaging Systemscore 13.2 · 7 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 |
|---|---|---|---|
| * | K212336 | Soteria.AISummary page 5…892.1650 Device Class: Class II Primary Product code: JAA Secondary product code: OWB Predicate Device K212336 Company Name: Omega Medical Imaging, LLC Address: 3400 St. Johns Parkway, Suite 1020, Sanford,… | 2021 |
| † | K182834 | CS-series-FP with Optional ROI Accessory CA-100S | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 34 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 16 of the 27 ancestors have a recall of any class.
How does its category compare?
All JAA devicesJAA System, X-Ray, Fluoroscopic, Image-Intensified: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · JAA
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAA
89in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAA
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAA
33in 2025
MAUDE reports naming product code JAA, 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 | 1 | — | 35 | 9,517 |
| 2008 | 6 | 18 | 21 | 9,484 |
| 2009 | 0 | — | 18 | 12,040 |
| 2010 | 1 | — | 6 | 5,803 |
| 2011 | 4 | 48 | 7 | 14,000 |
| 2012 | 1 | — | 2 | 11,684 |
| 2013 | 6 | 129 | 3 | 13,706 |
| 2014 | 6 | 276 | 1 | 10,265 |
| 2015 | 3 | 197 | 1 | 2,922 |
| 2016 | 2 | — | 7 | 35 |
| 2017 | 1 | — | 3 | 56 |
| 2018 | 3 | 30 | 1 | 36 |
| 2019 | 6 | 49 | 2 | 49 |
| 2020 | 4 | 39 | 2 | 39 |
| 2021 | 6 | 104 | 2 | 35 |
| 2022 | 1 | — | 5 | 34 |
| 2023 | 2 | — | 9 | 41 |
| 2024 | 3 | 89 | 2 | 25 |
| 2025 | 2 | — | 4 | 33 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The System is intended for use in Radiographic / Fluoroscopic applications including general
radiographic / fluoroscopic diagnostic, and interventional X-Ray imaging for General and Pediatric
Populations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242488 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242488: Soteria E-View.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242488
Report an extraction error
Are you the manufacturer?
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