510(k) · Cleared
ClearedZiehm Vision FD 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 Jul 7, 2006 as substantially equivalent to K011292 (Ziehm International, Inc., 2001) after a 35-day review. Its family tree reaches back 1 generation to 2001. 34 later devices descend from it.
- Decided
- Jul 7, 2006
- Review
- 35 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011292 (2001). 34 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK011292 Ziehm VisionZiehm International, Inc. · 2001
- This deviceK061534 Ziehm Vision FD Digital Mobile Imaging SystemZiehm Imaging, Inc. · 2006
- Descendant · cites it directly · 28 of its ownK073346 Ziehm Vision 2Ziehm Imaging, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 17 of its ownK083545 Ziehm Vision RFDZiehm Imaging, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 16 of its ownK132904 Ziehm Vision RFDZiehm Imaging GmbH · 2013 · Recalled
- Descendant · 2 generations on · 10 of its ownK142740 Ziehm Vision RFD 3DZiehm Imaging GmbH · 2015 · Recalled
- Descendant · 2 generations on · 9 of its ownK092438 Ziehm SoloZiehm Imaging, Inc. · 2009 · Recalled
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K073346Ziehm Vision 2Ziehm Imaging, Inc. · 2008 · cites it directly28descendants
- K083545Ziehm Vision RFDZiehm Imaging, Inc. · 2009 · 2 generations on17descendants
- K132904Ziehm Vision RFDZiehm Imaging GmbH · 2013 · 3 generations on16descendants
- K142740Ziehm Vision RFD 3DZiehm Imaging GmbH · 2015 · 2 generations on10descendants
- K092438Ziehm SoloZiehm Imaging, Inc. · 2009 · 2 generations on9descendants
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) | K061534 | Ziehm Vision FD Digital Mobile Imaging System | Ziehm Imaging, Inc. | 2006 | — |
| +1 | K073346 | Ziehm Vision 2 | Ziehm Imaging, Inc. | 2008 | 5 |
| +2 | K083545 | Ziehm Vision RFD | Ziehm Imaging, Inc. | 2009 | 3 |
| +3 | K132904 | Ziehm Vision RFD | Ziehm Imaging GmbH | 2013 | 1 |
| +2 | K142740 | Ziehm Vision RFD 3D | Ziehm Imaging GmbH | 2015 | 1 |
| +2 | K092438 | Ziehm Solo | Ziehm Imaging, Inc. | 2009 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 7 | 0 |
| 2026 | 3 | 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? (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 |
|---|---|---|---|
| * | K011292 | Ziehm VisionSummary page 1…s and is substantially equivalent to the following current legally marketed devise ZIEHM VISION. - Ziehm Imaging, Inc. ZIEHM VISION Digital Mobile Imaging System 510(k) K011292 The device is a mobile C-arm type x-ray system intended for fluoroscopic imaging. The systems include high-voltage x-ray generat… | 2001 |
What descends from it? (34)
See all 342 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.
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 Zichm Vision FD is intended to provide pulsed and continuous fluoroscopic imaging of patieats during diagnostic, interventional and surgical procedures. Is intended for use in visualizing complex anatomical structures and procedures such as, vascular, cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, critical care, emergency room procedures, and where higher accuracy in image geometry is required. At the discretion of a physician the device may be used for other imaging applications.
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/K061534 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061534: Ziehm Vision FD Digital Mobile Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061534
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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