510(k) · Cleared
ClearedZen-7000, Fluoroscopic X-Ray System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genoray America, Inc. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Mar 29, 2011 as substantially equivalent to K021049 (Ge Oec Medical Systems, 2002) after a 127-day review. Its family tree reaches back 1 generation to 2002. 1 of the 5 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Mar 29, 2011
- Review
- 127 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021049 (2002). 3 later devices descend from it, 1 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK021049 Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · Recalled (Class I)
- This deviceK103425 Zen-7000, Fluoroscopic X-Ray SystemGenoray America, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK140041 Zen-7000,System,Fluroscopic X-Ray SystemGenoray Co., Ltd. · 2014
- Descendant · 2 generations on · 1 of its ownK172180 OSCAR 15Genoray Co., Ltd. · 2018
- Descendant · 3 generations on · 0 of its ownK230787 Oscar 15 & Oscar 15iGenoray Co., Ltd. · 2023
Class I recalls in this family
- K021049 Oec 9800 Plus Digital Mobile Imaging Systemdirect predicate · 2002
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021049 | Oec 9800 Plus Digital Mobile Imaging System | Ge Oec Medical Systems | 2002 | Class I |
| 0 (this device) | K103425 | Zen-7000, Fluoroscopic X-Ray System | Genoray America, Inc. | 2011 | — |
| +1 | K140041 | Zen-7000,System,Fluroscopic X-Ray System | Genoray Co., Ltd. | 2014 | — |
| +2 | K172180 | OSCAR 15 | Genoray Co., Ltd. | 2018 | — |
| +3 | K230787 | Oscar 15 & Oscar 15i | Genoray Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K021049 | Oec 9800 Plus Digital Mobile Imaging SystemSummary page 1…e Manufacturer: GE OEC Medical Systems, Inc Device Name: OEC 9800 Plus 5 10(k) Number: K021049 (Decision Date -April .17, 2002) Classification: System, X-Ray, Fluoroscopic, Image-Intensified: JAA,… | 2002 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140041 | Zen-7000,System,Fluroscopic X-Ray System | 2014 | 2 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K021049Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · Direct predicate · ◆ on the line of descent in FIG. 11 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. 2011, 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-7000 Digital mobile Imaging system is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103425 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103425: Zen-7000, Fluoroscopic X-Ray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103425
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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