510(k) · Cleared
ClearedModel B-200 C-Arm & Model C-300 Cardiac Table
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omega Medical Imaging, Inc. · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Cleared on Sep 20, 1990 after a 139-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Sep 20, 1990
- Review
- 139 days
- Class
- Class II
- Product code
- JAA
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 1 citing it directly.
- This deviceK902005 Model B-200 C-Arm & Model C-300 Cardiac TableOmega Medical Imaging, Inc. · 1990
- Descendant · cites it directly · 10 of its ownK062647 E-View Fluoroscopy System, Model CS-50Omega Medical Imaging, Inc. · 2006
- Descendant · 2 generations on · 9 of its ownK070834 CS-Series Fluoroscopy System, CS-10 Through CS-65 (11 Configurations)Omega Medical Imaging, Inc. · 2007
- Descendant · 3 generations on · 8 of its ownK100102 CS-Series-FPOmega Medical Imaging, Inc. · 2010
- Descendant · 4 generations on · 7 of its ownK121293 CS-Series-FP with 3030+OptionOmega Medical Imaging, LLC · 2012
- Descendant · 5 generations on · 4 of its ownK182834 CS-series-FP with Optional ROI Accessory CA-100SOmega Medical Imaging, LLC · 2019
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K062647E-View Fluoroscopy System, Model CS-50Omega Medical Imaging, Inc. · 2006 · cites it directly10descendants
- K070834CS-Series Fluoroscopy System, CS-10 Through CS-65 (11 Configurations)Omega Medical Imaging, Inc. · 2007 · 2 generations on9descendants
- K100102CS-Series-FPOmega Medical Imaging, Inc. · 2010 · 3 generations on8descendants
- K121293CS-Series-FP with 3030+OptionOmega Medical Imaging, LLC · 2012 · 4 generations on7descendants
- K182834CS-series-FP with Optional ROI Accessory CA-100SOmega Medical Imaging, LLC · 2019 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K902005 | Model B-200 C-Arm & Model C-300 Cardiac Table | Omega Medical Imaging, Inc. | 1990 | — |
| +1 | K062647 | E-View Fluoroscopy System, Model CS-50 | Omega Medical Imaging, Inc. | 2006 | — |
| +2 | 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 | — |
| +4 | K121293 | CS-Series-FP with 3030+Option | Omega Medical Imaging, LLC | 2012 | — |
| +5 | K182834 | CS-series-FP with Optional ROI Accessory CA-100S | Omega Medical Imaging, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062647 | E-View Fluoroscopy System, Model CS-50 | 2006 | 10 |
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?
- Of its descendants, K062647 (Omega Medical Imaging, Inc., 2006) has gone furthest, with 10 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K902005 · printed Nov 6, 2026
Cite this page
510(k) Report. “K902005: Model B-200 C-Arm & Model C-300 Cardiac Table.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K902005
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026