510(k) · Cleared
Recalled · Class II · 2024Ziehm Vision R Digital Mobile Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ziehm Imaging, Inc. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Jun 19, 2006 as substantially equivalent to K011292 (Ziehm International, Inc., 2001) and 2 other predicates after a 49-day review. Its family tree reaches back 1 generation to 2001. 2 of the 22 devices in its family, counting itself, have a Class I recall. 18 later devices descend from it. It has been recalled 4 times.
- Decided
- Jun 19, 2006
- Review
- 49 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 1 generation to K011292 (2001). 3 ancestors in all. 18 later devices descend from it, 1 citing it directly. 2 of the 22 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK011292 Ziehm VisionZiehm International, Inc. · 2001
- This deviceK061203 Ziehm Vision R Digital Mobile Imaging SystemZiehm Imaging, Inc. · 2006
- Descendant · cites it directly · 17 of its ownK083545 Ziehm Vision RFDZiehm Imaging, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 16 of its ownK132904 Ziehm Vision RFDZiehm Imaging GmbH · 2013 · Recalled
- Descendant · 3 generations on · 10 of its ownK142740 Ziehm Vision RFD 3DZiehm Imaging GmbH · 2015 · Recalled
- Descendant · 4 generations on · 4 of its ownK202360 Ziehm Vision RFD 3DZiehm Imaging GmbH · 2020
- Descendant · 5 generations on · 3 of its ownK231701 Ziehm Vision RFD 3DZiehm Imaging GmbH · 2023 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 18 · See all- K083545Ziehm Vision RFDZiehm Imaging, Inc. · 2009 · cites it directly17descendants
- K132904Ziehm Vision RFDZiehm Imaging GmbH · 2013 · 2 generations on16descendants
- K142740Ziehm Vision RFD 3DZiehm Imaging GmbH · 2015 · 3 generations on10descendants
- K202360Ziehm Vision RFD 3DZiehm Imaging GmbH · 2020 · 4 generations on4descendants
- K231701Ziehm Vision RFD 3DZiehm Imaging GmbH · 2023 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011292 | Ziehm Vision | Ziehm International, Inc. | 2001 | — |
| 0 (this device) | K061203 | Ziehm Vision R Digital Mobile Imaging System | Ziehm Imaging, Inc. | 2006 | — |
| +1 | K083545 | Ziehm Vision RFD | Ziehm Imaging, Inc. | 2009 | 3 |
| +2 | K132904 | Ziehm Vision RFD | Ziehm Imaging GmbH | 2013 | 1 |
| +3 | K142740 | Ziehm Vision RFD 3D | Ziehm Imaging GmbH | 2015 | 1 |
| +4 | K202360 | Ziehm Vision RFD 3D | Ziehm Imaging GmbH | 2020 | — |
| +5 | K231701 | Ziehm Vision RFD 3D | Ziehm Imaging GmbH | 2023 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 1 |
| 2003 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K011292 | Ziehm VisionSummary page 1…IEHM VISION R is substantially equivalent to the following devices that are currently marketed: — Zichm Imaging, Inc. ZIEHM VISION Digital Mobile Imaging System 510(k) K011292 - OEC 9800 Plus Digital Mobile Imaging System 510(k) K021049 - QOEC9800 E/CV' Digital Mobile Imaging System 510(k) K024012 These… | 2001 |
| * | K021049 | Oec 9800 Plus Digital Mobile Imaging SystemSummary page 1…vices that are currently marketed: — Zichm Imaging, Inc. ZIEHM VISION Digital Mobile Imaging System 510(k) K011292 - OEC 9800 Plus Digital Mobile Imaging System 510(k) K021049 - QOEC9800 E/CV' Digital Mobile Imaging System 510(k) K024012 These devices are mobile C-arm type x-ray systems intended for flu… | 2002 |
| * | K024012 | Oec 9800 E/CV+ Digital Mobile Imaging SystemSummary page 1…HM VISION Digital Mobile Imaging System 510(k) K011292 - OEC 9800 Plus Digital Mobile Imaging System 510(k) K021049 - QOEC9800 E/CV' Digital Mobile Imaging System 510(k) K024012 These devices are mobile C-arm type x-ray systems intended for fluoroscopic imaging. The systems include high-voltage x-ray gene… | 2003 |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083545 | Ziehm Vision RFD | 2009 | 17 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 8, 2024 | Class II | Z-0577-2025 | Radiation Control for Health and Safety Act | Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when… |
| Apr 15, 2016 | Class II | Z-2642-2016 | Device Design | Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted. |
| Nov 21, 2013 | Class II | Z-0567-2014 | Device Design | Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices. |
| Apr 29, 2011 | Not classified | Z-1430-2012 | Component design/selection | On 04/29/2011, Ziehm Imaging, Inc., Orlando, FL recalled the double foot switch, type KF 2 1S/1S-MED-AP, a component used with Ziehm Imaging GmbH Mobile C-arm due to the potential of unintentional continued activation of fluoroscopic… |
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.
- K024012Oec 9800 E/CV+ Digital Mobile Imaging SystemGe Oec Medical Systems · 2003 · Direct predicate · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K021049Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · Direct predicate · ◆ in the 2002 ancestors bar of 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.
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 Ziehm Vision R is designed to provide pulsed and continuous fluoroscopic imaging, and spot film imaging of the patient during diagnostic, Interventional and surgical procedures. The design includes features for diagnostic and interventional cardiac imaging procedures, and is also intended for use in visualizing complex anatomical structures and procedures for vascular, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, and critical care and emergency room procedures. At the physician's discretion the device may be used for other imaging applications.
Radiographic film examinations can be made with an accessory cassette device attached to the Image Intensifier.
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/K061203 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061203: Ziehm Vision R Digital Mobile Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061203
Report an extraction error
Are you the manufacturer?
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