510(k) · Cleared
Recalled · Class II · 2024Ziehm Solo
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 Dec 23, 2009 as substantially equivalent to K073346 (Ziehm Imaging, Inc., 2008) after a 138-day review. Its family tree reaches back 4 generations to 2000. 1 of the 18 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it. It has been recalled 4 times.
- Decided
- Dec 23, 2009
- Review
- 138 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 4 generations to K003266 (2000). 8 ancestors in all. 9 later devices descend from it, 1 citing it directly. 1 of the 18 devices in this family, counting this one, has 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 deviceK092438 Ziehm SoloZiehm Imaging, Inc. · 2009
- Descendant · cites it directly · 8 of its ownK161976 Ziehm Solo FDZiehm Imaging GmbH · 2016 · Recalled
- Descendant · 2 generations on · 4 of its ownK183220 OrthoScan TAU Mini C-ArmOrthoscan, Inc. · 2019
- Descendant · 3 generations on · 3 of its ownK213113 Orthoscan Tau Mini C-ArmOrthoscan, Inc. · 2021
- Descendant · 4 generations on · 2 of its ownK243452 Orthoscan VERSA Mini C-ArmZiehm-Orthoscan, Inc. · 2025 · Recalled
- Descendant · 2 generations on · 2 of its ownK231669 Ziehm Solo FDZiehm Imaging GmbH · 2023
Showing 5 of 9 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 9 · See all- K161976Ziehm Solo FDZiehm Imaging GmbH · 2016 · cites it directly8descendants
- K183220OrthoScan TAU Mini C-ArmOrthoscan, Inc. · 2019 · 2 generations on4descendants
- K213113Orthoscan Tau Mini C-ArmOrthoscan, Inc. · 2021 · 3 generations on3descendants
- K243452Orthoscan VERSA Mini C-ArmZiehm-Orthoscan, Inc. · 2025 · 4 generations on2descendants
- K231669Ziehm Solo FDZiehm Imaging GmbH · 2023 · 2 generations on2descendants
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) | K092438 | Ziehm Solo | Ziehm Imaging, Inc. | 2009 | — |
| +1 | K161976 | Ziehm Solo FD | Ziehm Imaging GmbH | 2016 | 1 |
| +2 | K183220 | OrthoScan TAU Mini C-Arm | Orthoscan, Inc. | 2019 | — |
| +3 | K213113 | Orthoscan Tau Mini C-Arm | Orthoscan, Inc. | 2021 | — |
| +4 | K243452 | Orthoscan VERSA Mini C-Arm | Ziehm-Orthoscan, Inc. | 2025 | 1 |
| +2 | K231669 | Ziehm Solo FD | Ziehm Imaging GmbH | 2023 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K073346 | Ziehm Vision 2Summary page 1…n/Usual Names: Digital Mobile C-Arm Mobile Surgical C-Arm Mob ile C-Arm Predicate Device: ZIEHM VISION 2 K(073346, 21CFR 892.1650, System, X-Ray, Fluoroscopic, Image Intensifier, Product Code J… | 2008 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161976 | Ziehm Solo FD | 2016 | 8 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 8, 2024 | Class II | Z-0573-2025 | 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… |
| Apr 15, 2016 | Class II | Z-2643-2016 | 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-0563-2014 | 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.
- 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.
- 3 of the 8 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K161976 (Ziehm Imaging GmbH, 2016) has gone furthest, with 8 descendants of its own.
- 3 other devices also cite its predicate K073346.
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 Solo is intended to provide contactless fluoroscopy Imaging, capturing, temporarily storing, and display of non-invasive x-ray imaging of the patient using pulsed and continuous fluoroscopy, during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care,, and emergency room fluoroscopy procedures. Radiographic film examinations can be made with an accessory cassette device when attached to the Image Intensifier. This device does not support and is not intended for use in performing mammographic imaging.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092438 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092438: Ziehm Solo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092438
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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