510(k) · Cleared
Recalled · Class II · 2016Ziehm Vision RFD
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 May 15, 2009 as substantially equivalent to K061203 (Ziehm Imaging, Inc., 2006) and 1 other predicate after a 168-day review. Its family tree reaches back 4 generations to 2000. 3 of the 29 devices in its family, counting itself, have a Class I recall. 17 later devices descend from it. It has been recalled 3 times.
- Decided
- May 15, 2009
- Review
- 168 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 4 generations to K003266 (2000). 11 ancestors in all. 17 later devices descend from it, 1 citing it directly. 3 of the 29 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK003266 Siremobil Iso-C 3DSiemens Medical Solutions USA, Inc. · 2000
- 3 generations backK032280 Siremobil Iso-C 3DSiemens AG · 2003
- 2 generations backK061310 Ziehm Vario 3D Digital Mobile Imaging SystemZiehm Imaging, Inc. · 2006
- 1 generation backK073346 Ziehm Vision 2Ziehm Imaging, Inc. · 2008 · Recalled
- This deviceK083545 Ziehm Vision RFDZiehm Imaging, Inc. · 2009
- Descendant · cites it directly · 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 · 3 generations on · 4 of its ownK202360 Ziehm Vision RFD 3DZiehm Imaging GmbH · 2020
- Descendant · 4 generations on · 3 of its ownK231701 Ziehm Vision RFD 3DZiehm Imaging GmbH · 2023 · Recalled
- Descendant · 2 generations on · 3 of its ownK203428 Ziehm Vision RFDZiehm Imaging GmbH · 2021
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 17 · See all- K132904Ziehm Vision RFDZiehm Imaging GmbH · 2013 · cites it directly16descendants
- K142740Ziehm Vision RFD 3DZiehm Imaging GmbH · 2015 · 2 generations on10descendants
- K202360Ziehm Vision RFD 3DZiehm Imaging GmbH · 2020 · 3 generations on4descendants
- K231701Ziehm Vision RFD 3DZiehm Imaging GmbH · 2023 · 4 generations on3descendants
- K203428Ziehm Vision RFDZiehm Imaging GmbH · 2021 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003266 | Siremobil Iso-C 3D | Siemens Medical Solutions USA, Inc. | 2000 | — |
| −3 | K032280 | Siremobil Iso-C 3D | Siemens AG | 2003 | — |
| −2 | K061310 | Ziehm Vario 3D Digital Mobile Imaging System | Ziehm Imaging, Inc. | 2006 | — |
| −1 | K073346 | Ziehm Vision 2 | Ziehm Imaging, Inc. | 2008 | 5 |
| 0 (this device) | K083545 | Ziehm Vision RFD | Ziehm Imaging, Inc. | 2009 | — |
| +1 | K132904 | Ziehm Vision RFD | Ziehm Imaging GmbH | 2013 | 1 |
| +2 | K142740 | Ziehm Vision RFD 3D | Ziehm Imaging GmbH | 2015 | 1 |
| +3 | K202360 | Ziehm Vision RFD 3D | Ziehm Imaging GmbH | 2020 | — |
| +4 | K231701 | Ziehm Vision RFD 3D | Ziehm Imaging GmbH | 2023 | 1 |
| +2 | K203428 | Ziehm Vision RFD | Ziehm Imaging GmbH | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 1 |
| 2002 | 1 | 1 |
| 2003 | 1 | 1 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
3 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 |
|---|---|---|---|
| * | K061203 | Ziehm Vision R Digital Mobile Imaging SystemSummary page 1…ence: The ZIEIIM VISION RFD mobilc c-arm has been found to be substuntially equivalent to the following current legally marketed devises. Zichm Imaging, ZIEHM VISION R K061203 Product Code JAA & 1ZL Zichm Imaging, ZIEHM VISION? FD K073346 Product Code JAA, MQB & 1ZL These devices are mobile C-arm type x… | 2006 |
| * | K073346 | Ziehm Vision 2Summary page 1…substuntially equivalent to the following current legally marketed devises. Zichm Imaging, ZIEHM VISION R K061203 Product Code JAA & 1ZL Zichm Imaging, ZIEHM VISION? FD K073346 Product Code JAA, MQB & 1ZL These devices are mobile C-arm type x-ray systems intended for fluoroscopic imaging. The systems inc… | 2008 |
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132904 | Ziehm Vision RFD | 2013 | 16 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 15, 2016 | Class II | Z-2641-2016 | 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-0568-2014 | 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 · 2 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K021049Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · 2 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
- K003837Flexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems · 2001 · 4 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 6 of the 11 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K132904 (Ziehm Imaging GmbH, 2013) has gone furthest, with 16 descendants 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. 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?
The ZIEHM VISION RFD is intended for use in providing medical imaging, using pulsed and continuous fluoroscopic digital imaging, as well as digital subtraction and cine image capture during diagnostic interventional, and surgical procedures where intra-operative imaging and visualization of complex anatomical structures of both lower and higher contrast density are required, such procedures may included but are not limited to those of interventional…
Read the full statement (199 words)
The ZIEHM VISION RFD is intended for use in providing medical imaging, using pulsed and continuous fluoroscopic digital imaging, as well as digital subtraction and cine image capture during diagnostic interventional, and surgical procedures where intra-operative imaging and visualization of complex anatomical structures of both lower and higher contrast density are required, such procedures may included but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures, and those procedures visualizing structures of the cervical, thoracic, and lumber regions of the spine and joint fractures of the upper and lower extremities, and where digital image data is required for computer aided surgery procedures and whenever the clinician benefits from the high degree of geometric imaging accuracy, and where such fluoroscopic, cine and DSA imaging is required in and around high magnetic fields. The visualization of such anatomical structures assists the clinician in the clinical outcome. At the discretion of a physician the device may be used for other imaging applications.
This device does not support direct radiographic film exposures and is not intended for use in performing mammography.
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/K083545 · printed Nov 3, 2026
Cite this page
510(k) Report. “K083545: Ziehm Vision RFD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K083545
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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