510(k) · Cleared
Recalled · Class II · 2024Ziehm Vision RFD 3D
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 Jul 10, 2023 as substantially equivalent to K202360 (Ziehm Imaging GmbH, 2020) after a 28-day review. Its family tree reaches back 8 generations to 2000. 3 of the 19 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled once.
- Decided
- Jul 10, 2023
- Review
- 28 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 8 generations to K003266 (2000). 15 ancestors in all. 3 later devices descend from it, 1 citing it directly. 3 of the 19 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK003266 Siremobil Iso-C 3DSiemens Medical Solutions USA, Inc. · 2000
- 7 generations backK032280 Siremobil Iso-C 3DSiemens AG · 2003
- 6 generations backK061310 Ziehm Vario 3D Digital Mobile Imaging SystemZiehm Imaging, Inc. · 2006
- 5 generations backK073346 Ziehm Vision 2Ziehm Imaging, Inc. · 2008 · Recalled
- 4 generations backK083545 Ziehm Vision RFDZiehm Imaging, Inc. · 2009 · Recalled
- 3 generations backK132904 Ziehm Vision RFDZiehm Imaging GmbH · 2013 · Recalled
- 2 generations backK142740 Ziehm Vision RFD 3DZiehm Imaging GmbH · 2015 · Recalled
- 1 generation backK202360 Ziehm Vision RFD 3DZiehm Imaging GmbH · 2020
- This deviceK231701 Ziehm Vision RFD 3DZiehm Imaging GmbH · 2023
- Descendant · cites it directly · 2 of its ownK243303 Ziehm Vision RFD 3DZiehm Imaging GmbH · 2025
- Descendant · 2 generations on · 0 of its ownK253296 Digital C-ARM with 3DAllengers Medical Systems Limited · 2026
- Descendant · 2 generations on · 0 of its ownK252735 C-beamPulmera, Inc. · 2026
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K003266 | Siremobil Iso-C 3D | Siemens Medical Solutions USA, Inc. | 2000 | — |
| −7 | K032280 | Siremobil Iso-C 3D | Siemens AG | 2003 | — |
| −6 | K061310 | Ziehm Vario 3D Digital Mobile Imaging System | Ziehm Imaging, Inc. | 2006 | — |
| −5 | K073346 | Ziehm Vision 2 | Ziehm Imaging, Inc. | 2008 | 5 |
| −4 | 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 |
| −1 | K202360 | Ziehm Vision RFD 3D | Ziehm Imaging GmbH | 2020 | — |
| 0 (this device) | K231701 | Ziehm Vision RFD 3D | Ziehm Imaging GmbH | 2023 | — |
| +1 | K243303 | Ziehm Vision RFD 3D | Ziehm Imaging GmbH | 2025 | — |
| +2 | K253296 | Digital C-ARM with 3D | Allengers Medical Systems Limited | 2026 | — |
| +2 | K252735 | C-beam | Pulmera, Inc. | 2026 | — |
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 |
|---|---|---|
| 2025 | 1 | 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? (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 |
|---|---|---|---|
| * | K202360 | Ziehm Vision RFD 3DSummary page 4…ber 892.1650 Product Code owB I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K202360 Ziehm Vision RFD 3D OwB Device Description Summary 21 CFR 807.92(a)(4) The device Ziehm Vision RFD 3D is a medical Fluoroscopic… | 2020 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243303 | Ziehm Vision RFD 3D | 2025 | 2 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 8, 2024 | Class II | Z-0579-2025 | 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… |
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 · 6 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K021049Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · 6 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
- K003837Flexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems · 2001 · 6 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 9 of the 15 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K243303 (Ziehm Imaging GmbH, 2025) has gone furthest, with 2 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. 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 RFD 3D system is intended for use in providing both 2D and 3D pulsed and continuous fluoroscopic medical imaging for adult and pediatric populations. The device provides 2D medical imaging for fluoroscopy, digital subtraction, and acquisition of cine loops during diagnostic interventional and surgical procedures where intra-operative imaging and visualization of complex anatomical structures of both lower and higher contrast density are…
Read the full statement (256 words)
The Ziehm Vision RFD 3D system is intended for use in providing both 2D and 3D pulsed and
continuous fluoroscopic medical imaging for adult and pediatric populations.
The device provides 2D medical imaging for fluoroscopy, digital subtraction, and acquisition of cine
loops 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 include 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 lumbar regions of the spine and joint fractures of the upper
and lower extremities, and where digital image data is required for Computer-Assisted Surgery
procedures.
The device is also intended to provide 3D medical imaging of patients during orthopedic,
neurological, intra-operative surgical procedures and where the clinician benefits from 3D
visualization of complex anatomical structures, such as but not limited to those of high contrast
objects, bones, joints, maxillofacial, cervical, thoracic, and lumbar regions of the spine, pelvis,
acetabulum and joint fractures of the upper and lower extremities, and where digital image and C-
arm positioning data is required for Computer-Assisted Surgery 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K231701 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231701: Ziehm Vision RFD 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231701
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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