510(k) · Cleared
ClearedZiehm Vision FD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ziehm Imaging GmbH · OWB Interventional Fluoroscopic X-Ray System
Cleared on Dec 15, 2023 as substantially equivalent to K193230 (Ziehm Imaging GmbH, 2019) after a 186-day review. Its family tree reaches back 3 generations to 2001. 2 later devices descend from it.
- Decided
- Dec 15, 2023
- Review
- 186 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K011292 (2001). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK011292 Ziehm VisionZiehm International, Inc. · 2001
- 2 generations backK061534 Ziehm Vision FD Digital Mobile Imaging SystemZiehm Imaging, Inc. · 2006
- 1 generation backK193230 Ziehm Vision FDZiehm Imaging GmbH · 2019
- This deviceK231700 Ziehm Vision FDZiehm Imaging GmbH · 2023
- Descendant · cites it directly · 1 of its ownK240020 Ziehm Vision FDZiehm Imaging GmbH · 2024 · Recalled
- Descendant · 2 generations on · 0 of its ownK243735 Ziehm Vision FDZiehm Imaging GmbH · 2025
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 |
|---|---|---|---|---|---|
| −3 | K011292 | Ziehm Vision | Ziehm International, Inc. | 2001 | — |
| −2 | K061534 | Ziehm Vision FD Digital Mobile Imaging System | Ziehm Imaging, Inc. | 2006 | — |
| −1 | K193230 | Ziehm Vision FD | Ziehm Imaging GmbH | 2019 | — |
| 0 (this device) | K231700 | Ziehm Vision FD | Ziehm Imaging GmbH | 2023 | — |
| +1 | K240020 | Ziehm Vision FD | Ziehm Imaging GmbH | 2024 | 1 |
| +2 | K243735 | Ziehm Vision FD | Ziehm Imaging GmbH | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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.
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 |
|---|---|---|---|
| * | K193230 | Ziehm Vision FDSummary page 5…1/16 Product Code: OWB , JAA Product Class: II Predicate Device: K193230 Ziehm Vision FD Decision Date: 20/12/2019 Regulation: 21CFR 892.1650 Re… | 2019 |
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 |
|---|---|---|---|
| K240020 | Ziehm Vision FD | 2024 | 1 |
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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K240020 (Ziehm Imaging GmbH, 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K193230.
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. 2023, 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 FD is intended for use in providing medical imaging for adults and pediatric populations, using pulsed and continuous fluoroscopic imaging. The device provides contactless fluoroscopic image capture, temporarily storing, and display of digital subtraction, and acquisition of cine loops during diagnostic, interventional and surgical procedures. Examples of clinical application may include pediatric, cholangiography, endoscopic, urologic…
Read the full statement (112 words)
The Ziehm Vision FD is intended for use in providing medical imaging for adults and pediatric populations, using pulsed and continuous fluoroscopic imaging. The device provides contactless fluoroscopic image capture, temporarily storing, and display of digital subtraction, and acquisition of cine loops during diagnostic, interventional and surgical procedures. Examples of clinical application may include pediatric, cholangiography, endoscopic, urologic, lithotripsy, orthopedic, neurologic, vascular, cardiac, angiographic, critical care, and emergency room fluoroscopy procedures.
The visualization of such anatomical structures assists the clinician in the clinical outcome. This device does not support direct radiographic film exposures and is not intended for use in performing mammography. The system is not intended for use near MRI systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231700 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231700: Ziehm Vision FD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231700
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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