510(k) · Cleared
Recalled · Class II · 2017Ziehm Solo 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 Oct 6, 2016 as substantially equivalent to K092438 (Ziehm Imaging, Inc., 2009) and 1 other predicate after an 80-day review. Its family tree reaches back 5 generations to 2000. 1 of the 18 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it. It has been recalled once.
- Decided
- Oct 6, 2016
- Review
- 80 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K003266 (2000). 9 ancestors in all. 8 later devices descend from it, 2 citing it directly. 1 of the 18 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK003266 Siremobil Iso-C 3DSiemens Medical Solutions USA, Inc. · 2000
- 4 generations backK032280 Siremobil Iso-C 3DSiemens AG · 2003
- 3 generations backK061310 Ziehm Vario 3D Digital Mobile Imaging SystemZiehm Imaging, Inc. · 2006
- 2 generations backK073346 Ziehm Vision 2Ziehm Imaging, Inc. · 2008 · Recalled
- 1 generation backK092438 Ziehm SoloZiehm Imaging, Inc. · 2009 · Recalled
- This deviceK161976 Ziehm Solo FDZiehm Imaging GmbH · 2016
- Descendant · cites it directly · 4 of its ownK183220 OrthoScan TAU Mini C-ArmOrthoscan, Inc. · 2019
- Descendant · 2 generations on · 3 of its ownK213113 Orthoscan Tau Mini C-ArmOrthoscan, Inc. · 2021
- Descendant · 3 generations on · 2 of its ownK243452 Orthoscan VERSA Mini C-ArmZiehm-Orthoscan, Inc. · 2025 · Recalled
- Descendant · cites it directly · 2 of its ownK231669 Ziehm Solo FDZiehm Imaging GmbH · 2023
- Descendant · 3 generations on · 1 of its ownK250587 Orthoscan TAU Mini C-ArmZiehm-Orthoscan, Inc. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K003837 Flexiview 8800 Digital Mobile Imaging System4 generations back · 2001
Most influential descendants
Showing 5 of 8 · See all- K183220OrthoScan TAU Mini C-ArmOrthoscan, Inc. · 2019 · cites it directly4descendants
- K213113Orthoscan Tau Mini C-ArmOrthoscan, Inc. · 2021 · 2 generations on3descendants
- K243452Orthoscan VERSA Mini C-ArmZiehm-Orthoscan, Inc. · 2025 · 3 generations on2descendants
- K231669Ziehm Solo FDZiehm Imaging GmbH · 2023 · cites it directly2descendants
- K250587Orthoscan TAU Mini C-ArmZiehm-Orthoscan, Inc. · 2025 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003266 | Siremobil Iso-C 3D | Siemens Medical Solutions USA, Inc. | 2000 | — |
| −4 | K032280 | Siremobil Iso-C 3D | Siemens AG | 2003 | — |
| −3 | K061310 | Ziehm Vario 3D Digital Mobile Imaging System | Ziehm Imaging, Inc. | 2006 | — |
| −2 | K073346 | Ziehm Vision 2 | Ziehm Imaging, Inc. | 2008 | 5 |
| −1 | K092438 | Ziehm Solo | Ziehm Imaging, Inc. | 2009 | 4 |
| 0 (this device) | K161976 | Ziehm Solo FD | Ziehm Imaging GmbH | 2016 | — |
| +1 | K183220 | OrthoScan TAU Mini C-Arm | Orthoscan, Inc. | 2019 | — |
| +2 | K213113 | Orthoscan Tau Mini C-Arm | Orthoscan, Inc. | 2021 | — |
| +3 | K243452 | Orthoscan VERSA Mini C-Arm | Ziehm-Orthoscan, Inc. | 2025 | 1 |
| +1 | K231669 | Ziehm Solo FD | Ziehm Imaging GmbH | 2023 | — |
| +3 | K250587 | Orthoscan TAU Mini C-Arm | Ziehm-Orthoscan, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 1 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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.
1 device in this family has 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 |
|---|---|---|---|
| * | K092438 | Ziehm SoloSummary page 5…vice: Interventional fluoroscopic x-ray system Product Code: OWB, OXO, JAA Predicate Device: Ziehm Solo (K092438) Classification(s) 21CFR 892.1650 Classification Names: Image-intensified f… | 2009 |
| * | K073346 | Ziehm Vision 2Summary page 5…Interventional fluoroscopic x-ray system Product Code: OWB, OXO, JAA Predicate Device: Ziehm Vision² FD (K073346) Classification(s) 21CFR 892.1650 Classification Names: Image-intensified f… | 2008 |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 23, 2017 | Class II | Z-1893-2017 | Labeling design | During Ziehm Imaging GmbH FDA inspection, the label for the Collimator and X-ray Control panel was missing the manufacturer date as part of the identification for certified component |
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.
- 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 16 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 4 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K183220 (Orthoscan, Inc., 2019) has gone furthest, with 4 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. 2016, 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 Solo 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 (117 words)
The Ziehm Solo 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. 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/K161976 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161976: Ziehm Solo FD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161976
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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