510(k) · Cleared
ClearedCS-series-FP with Optional ROI Accessory CA-100S
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 Mar 29, 2019 as substantially equivalent to K121293 (Omega Medical Imaging, LLC, 2012) after a 171-day review. Its family tree reaches back 9 generations to 1991. 4 later devices descend from it.
- Decided
- Mar 29, 2019
- Review
- 171 days
- Class
- Class II
- Product code
- JAA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K912470 (1991). 25 ancestors in all, the oldest K860913 (1986). 4 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK912470 Philips Diagnost 96Philips Medical Systems, Inc. · 1991 · Recalled
- 5 generations between
- 3 generations backK070834 CS-Series Fluoroscopy System, CS-10 Through CS-65 (11 Configurations)Omega Medical Imaging, Inc. · 2007
- 2 generations backK100102 CS-Series-FPOmega Medical Imaging, Inc. · 2010
- 1 generation backK121293 CS-Series-FP with 3030+OptionOmega Medical Imaging, LLC · 2012
- This deviceK182834 CS-series-FP with Optional ROI Accessory CA-100SOmega Medical Imaging, LLC · 2019
- Descendant · cites it directly · 1 of its ownK212336 Soteria.AIOmega Medical Imaging, LLC · 2021
- Descendant · 2 generations on · 0 of its ownK242488 Soteria E-ViewOmega Medical Imaging, LLC · 2025
- Descendant · cites it directly · 0 of its ownK212890 Nyquist.IQOmega Medical Imaging, LLC · 2021
- Descendant · cites it directly · 0 of its ownK191713 CS-series-FP Radiographic / Fluoroscopic Systems with Optional…Omega Medical Imaging, LLC · 2019
Show all 9 generations
- Root · 9 generations backK912470 Philips Diagnost 96Philips Medical Systems, Inc. · 1991 · Recalled
- 8 generations backK960266 Siregraph CFSiemens Medical Solutions USA, Inc. · 1996 · Recalled
- 7 generations backK970734 Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic…Siemens Medical Solutions USA, Inc. · 1997
- 6 generations backK992660 Urf Digital - OTSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 5 generations backK040675 Axiom Artis USiemens Medical Systems, Inc. · 2004 · Recalled
- 4 generations backK062647 E-View Fluoroscopy System, Model CS-50Omega Medical Imaging, Inc. · 2006
- 3 generations backK070834 CS-Series Fluoroscopy System, CS-10 Through CS-65 (11 Configurations)Omega Medical Imaging, Inc. · 2007
- 2 generations backK100102 CS-Series-FPOmega Medical Imaging, Inc. · 2010
- 1 generation backK121293 CS-Series-FP with 3030+OptionOmega Medical Imaging, LLC · 2012
- This deviceK182834 CS-series-FP with Optional ROI Accessory CA-100SOmega Medical Imaging, LLC · 2019
Most influential descendants
Showing 4 of 4 · See all- K212336Soteria.AIOmega Medical Imaging, LLC · 2021 · cites it directly1descendant
- K242488Soteria E-ViewOmega Medical Imaging, LLC · 2025 · 2 generations on0descendants
- K212890Nyquist.IQOmega Medical Imaging, LLC · 2021 · cites it directly0descendants
- K191713CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™…Omega Medical Imaging, LLC · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K912470 | Philips Diagnost 96 | Philips Medical Systems, Inc. | 1991 | 9 |
| −8 | K960266 | Siregraph CF | Siemens Medical Solutions USA, Inc. | 1996 | 3 |
| −7 | K970734 | Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic X-Ray Systems | Siemens Medical Solutions USA, Inc. | 1997 | — |
| −6 | K992660 | Urf Digital - OT | Siemens Medical Solutions USA, Inc. | 1999 | 4 |
| −5 | K040675 | Axiom Artis U | Siemens Medical Systems, Inc. | 2004 | 1 |
| −4 | K062647 | E-View Fluoroscopy System, Model CS-50 | Omega Medical Imaging, Inc. | 2006 | — |
| −3 | K070834 | CS-Series Fluoroscopy System, CS-10 Through CS-65 (11 Configurations) | Omega Medical Imaging, Inc. | 2007 | — |
| −2 | K100102 | CS-Series-FP | Omega Medical Imaging, Inc. | 2010 | — |
| −1 | K121293 | CS-Series-FP with 3030+Option | Omega Medical Imaging, LLC | 2012 | — |
| 0 (this device) | K182834 | CS-series-FP with Optional ROI Accessory CA-100S | Omega Medical Imaging, LLC | 2019 | — |
| +1 | K212336 | Soteria.AI | Omega Medical Imaging, LLC | 2021 | — |
| +2 | K242488 | Soteria E-View | Omega Medical Imaging, LLC | 2025 | — |
| +1 | K212890 | Nyquist.IQ | Omega Medical Imaging, LLC | 2021 | — |
| +1 | K191713 | CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S /… | Omega Medical Imaging, LLC | 2019 | — |
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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 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 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 |
|---|---|---|---|
| * | K121293 | CS-Series-FP with 3030+OptionSummary page 4…892.1650 Device Class: Class II Primary Product code: JAA Secondary product code: OWB Predicate Device K121293 Company Name: Omega Medical Imaging, LLC Address: 675 Hickman Circle, Sanford, Florida 32771… | 2012 |
| † | K113052 | Infinix-Cci | 2011 |
What descends from it? (4)
3 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)
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 28 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 16 of the 25 ancestors have a recall of any class.
- Of its descendants, K212336 (Omega Medical Imaging, LLC, 2021) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K121293.
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. 2019, 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 Omega Medical Imaging, LLC CS-series-FP (SSXI) systems with optional accessory device CA-100S as a modification device to provide an automated Region of interest that manages exposure to the patient and operator. The system is intended for use in Radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging for General Populations.
At no time will the CA-100S be considered as a replacement for the primary collimator. The primary collimator shall always be used, in accordance with good medical practice, to define a Region of Interest
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182834 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182834: CS-series-FP with Optional ROI Accessory CA-100S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182834
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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