510(k) · Cleared
Recalled · 2009GE Oec Fluorostar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Oec Medical Systems, Inc. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Dec 22, 2004 after a 44-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it. It has been recalled once.
- Decided
- Dec 22, 2004
- Review
- 44 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 1
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK043076 GE Oec FluorostarGe Oec Medical Systems, Inc. · 2004
- Descendant · cites it directly · 4 of its ownK091918 Zen-2090 Pro, Fluoroscopic X-Ray System, Model Zen-2090 ProGenoray Co., Ltd. · 2009
- Descendant · 2 generations on · 1 of its ownK181943 OSCAR (OSCAR Prime, OSCAR Classic)Genoray Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK170946 Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm…Skanray Technologies Private Limited · 2017
- Descendant · 3 generations on · 0 of its ownK252229 Belliger AceGenoray Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK251893 Skan C PulsarSkanray Technologies Limited · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K091918Zen-2090 Pro, Fluoroscopic X-Ray System, Model Zen-2090 ProGenoray Co., Ltd. · 2009 · cites it directly4descendants
- K181943OSCAR (OSCAR Prime, OSCAR Classic)Genoray Co., Ltd. · 2018 · 2 generations on1descendant
- K170946Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V…Skanray Technologies Private Limited · 2017 · cites it directly1descendant
- K252229Belliger AceGenoray Co., Ltd. · 2026 · 3 generations on0descendants
- K251893Skan C PulsarSkanray Technologies Limited · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043076 | GE Oec Fluorostar | Ge Oec Medical Systems, Inc. | 2004 | — |
| +1 | K091918 | Zen-2090 Pro, Fluoroscopic X-Ray System, Model Zen-2090 Pro | Genoray Co., Ltd. | 2009 | — |
| +2 | K181943 | OSCAR (OSCAR Prime, OSCAR Classic) | Genoray Co., Ltd. | 2018 | — |
| +1 | K170946 | Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray… | Skanray Technologies Private Limited | 2017 | — |
| +3 | K252229 | Belliger Ace | Genoray Co., Ltd. | 2026 | — |
| +2 | K251893 | Skan C Pulsar | Skanray Technologies Limited | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (7)
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 |
|---|---|---|---|---|
| Feb 19, 2009 | Not classified | Z-1155-2009 | Radiation Control for Health and Safety Act | The alarm timer is reset after each exposure and therefore never reaches the five minute alarm state unless one exposure exceeds 5 minutes in duration. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K091918 (Genoray Co., Ltd., 2009) has gone furthest, with 4 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.
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 OEC Fluorostar is a mobile digital C-arm designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, stone localization, critical-care and emergency room procedures. The system may be used for other imaging applications at the physicians discretion.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K043076 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043076: GE Oec Fluorostar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043076
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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