510(k) · Cleared
ClearedZen-2090 Pro, Fluoroscopic X-Ray System, Model Zen-2090 Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genoray Co., Ltd. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Oct 7, 2009 as substantially equivalent to K043076 (Ge Oec Medical Systems, Inc., 2004) and 1 other predicate after a 99-day review. Its family tree reaches back 1 generation to 2001. 4 later devices descend from it.
- Decided
- Oct 7, 2009
- Review
- 99 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K010435 (2001). 2 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK010435 Philips BV Pulsera/EnduraPhilips Medical Systems, Inc. · 2001 · Recalled
- This deviceK091918 Zen-2090 Pro, Fluoroscopic X-Ray System, Model Zen-2090 ProGenoray Co., Ltd. · 2009
- Descendant · cites it directly · 1 of its ownK181943 OSCAR (OSCAR Prime, OSCAR Classic)Genoray Co., Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK252229 Belliger AceGenoray Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK233200 XPLUS 35 Series (XPLUS 35, XPLUS 35FD)Gemss Healthcare CO., LTD. · 2023
- Descendant · cites it directly · 0 of its ownK211780 ZEN-2090 TurboGenoray Co., Ltd. · 2022
Most influential descendants
Showing 4 of 4 · See all- K181943OSCAR (OSCAR Prime, OSCAR Classic)Genoray Co., Ltd. · 2018 · cites it directly1descendant
- K252229Belliger AceGenoray Co., Ltd. · 2026 · 2 generations on0descendants
- K233200XPLUS 35 Series (XPLUS 35, XPLUS 35FD)Gemss Healthcare CO., LTD. · 2023 · cites it directly0descendants
- K211780ZEN-2090 TurboGenoray Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010435 | Philips BV Pulsera/Endura | Philips Medical Systems, Inc. | 2001 | 12 |
| 0 (this device) | K091918 | Zen-2090 Pro, Fluoroscopic X-Ray System, Model Zen-2090 Pro | Genoray Co., Ltd. | 2009 | — |
| +1 | K181943 | OSCAR (OSCAR Prime, OSCAR Classic) | Genoray Co., Ltd. | 2018 | — |
| +2 | K252229 | Belliger Ace | Genoray Co., Ltd. | 2026 | — |
| +1 | K233200 | XPLUS 35 Series (XPLUS 35, XPLUS 35FD) | Gemss Healthcare CO., LTD. | 2023 | — |
| +1 | K211780 | ZEN-2090 Turbo | Genoray Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 18.3 · 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? (2)
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 |
|---|---|---|---|
| * | K043076 | GE Oec FluorostarSummary page 1…ly Marketed Device <GE OEC Fluorostar> Manufacturer: Device Name: 510(k) Number: Classification: GENORAY Co,, Ltd. GE OEC Mcdical Systems, Inc. GE OEC Fiuorostar K 043076 (Decision Date — Dec. 22, 2004) Image-Intensified Fluoroscopic X-Ray System: JAA, Class II per regulation 21 CFR 892.1650 16 of… | 2004 |
| * | K010435 | Philips BV Pulsera/EnduraSummary page 2…16 of 496 CONFIDENTIAL <Philips BV Endura> Manufacturer: Philips Mcdical Systems North America Company Device Name: " Philips BY Endura 510(k) Number: K010435 (Decision Date — Mar. 12, 2001) Classification: Image-Intensified Fluoroscopic X-Ray System: JAA, Class II per regulation 21 CF… | 2001 |
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?
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. 2009, 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?
ZEN-2090 Pro is a mobile digital C-arm designed to provide fluoroscopic and radiographic images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, orthopedic, neurologic, stone localization, critical care and emergency room procedures i.e. surgical interventions needing X-ray imaging and/or guidance and interventions inside and outside the operating room.
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/K091918 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091918: Zen-2090 Pro, Fluoroscopic X-Ray System, Model Zen-2090 Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091918
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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