510(k) · Cleared
ClearedZen-7000,System,Fluroscopic X-Ray System
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 Nov 28, 2014 as substantially equivalent to K103425 (Genoray America, Inc., 2011) and 1 other predicate after a 324-day review. Its family tree reaches back 4 generations to 2002. 2 of the 9 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Nov 28, 2014
- Review
- 324 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K021049 (2002). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly. 2 of the 9 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK021049 Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · Recalled (Class I)
- 3 generations backK041932 Oec Olympus Fluoroscopic Imaging SystemGe Oec Medical Systems, Inc. · 2004 · Recalled
- 2 generations backK073543 Oec 9900 EliteGe Oec Medical Systems · 2008 · Recalled
- 1 generation backK082781 Oec 9900 EliteGe Healthcare Surgery · 2009 · Recalled
- This deviceK140041 Zen-7000,System,Fluroscopic X-Ray SystemGenoray Co., Ltd. · 2014
- Descendant · cites it directly · 1 of its ownK172180 OSCAR 15Genoray Co., Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK230787 Oscar 15 & Oscar 15iGenoray Co., Ltd. · 2023
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K021049 | Oec 9800 Plus Digital Mobile Imaging System | Ge Oec Medical Systems | 2002 | Class I |
| −3 | K041932 | Oec Olympus Fluoroscopic Imaging System | Ge Oec Medical Systems, Inc. | 2004 | 7 |
| −2 | K073543 | Oec 9900 Elite | Ge Oec Medical Systems | 2008 | 5 |
| −1 | K082781 | Oec 9900 Elite | Ge Healthcare Surgery | 2009 | 4 |
| 0 (this device) | K140041 | Zen-7000,System,Fluroscopic X-Ray System | Genoray Co., Ltd. | 2014 | — |
| +1 | K172180 | OSCAR 15 | Genoray Co., Ltd. | 2018 | — |
| +2 | K230787 | Oscar 15 & Oscar 15i | Genoray Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 1 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
2 devices in this family have 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? (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 |
|---|---|---|---|
| * | K103425 | Zen-7000, Fluoroscopic X-Ray SystemSummary page 4…Predicate Device Manufacturer: GENORAY Co., Ltd. Trade Name: ZEN-7000 510(k) Number: K103425 (Decision Date ė Mar 29, 2011) Classification Name: System, X-Ray, Fluoroscopic, Image-Intensified… | 2011 |
| * | K082781 | Oec 9900 EliteSummary page 4…AA, OXO Manufacturer: GE Healthcare Surgery Trade Name: OEC 9900 Elite 510(k) Number: K082781 (Decision Date ė May 01, 2009) Classification Name: System, X-Ray, Fluoroscopic, Image-Intensified… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172180 | OSCAR 15 | 2018 | 1 |
Has anything in its family been recalled? (2 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 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K024012Oec 9800 E/CV+ Digital Mobile Imaging SystemGe Oec Medical Systems · 2003 · 3 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 5 of the 6 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K172180 (Genoray Co., Ltd., 2018) has gone furthest, with 1 descendant 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. 2014, 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 is a mobile fluoroscopy system is 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, 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/K140041 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140041: Zen-7000,System,Fluroscopic 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/K140041
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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