510(k) · Cleared
Recalled · 2026Orthoscan VERSA Mini C-Arm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ziehm-Orthoscan, Inc. · OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Cleared on Jan 14, 2025 as substantially equivalent to K213113 (Orthoscan, Inc., 2021) and 1 other predicate after a 68-day review. Its family tree reaches back 8 generations to 2000. 1 of the 17 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled once.
- Decided
- Jan 14, 2025
- Review
- 68 days
- Class
- Class II
- Product code
- OXO
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 8 generations to K003266 (2000). 14 ancestors in all. 2 later devices descend from it, 1 citing it directly. 1 of the 17 devices in this family, counting this one, has 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 backK092438 Ziehm SoloZiehm Imaging, Inc. · 2009 · Recalled
- 3 generations backK161976 Ziehm Solo FDZiehm Imaging GmbH · 2016 · Recalled
- 2 generations backK183220 OrthoScan TAU Mini C-ArmOrthoscan, Inc. · 2019
- 1 generation backK213113 Orthoscan Tau Mini C-ArmOrthoscan, Inc. · 2021
- This deviceK243452 Orthoscan VERSA Mini C-ArmZiehm-Orthoscan, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK250587 Orthoscan TAU Mini C-ArmZiehm-Orthoscan, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK252579 Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc. · 2026
Class I recalls in this family
- K003837 Flexiview 8800 Digital Mobile Imaging System7 generations back · 2001
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 |
|---|---|---|---|---|---|
| −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 | K092438 | Ziehm Solo | Ziehm Imaging, Inc. | 2009 | 4 |
| −3 | K161976 | Ziehm Solo FD | Ziehm Imaging GmbH | 2016 | 1 |
| −2 | K183220 | OrthoScan TAU Mini C-Arm | Orthoscan, Inc. | 2019 | — |
| −1 | K213113 | Orthoscan Tau Mini C-Arm | Orthoscan, Inc. | 2021 | — |
| 0 (this device) | K243452 | Orthoscan VERSA Mini C-Arm | Ziehm-Orthoscan, Inc. | 2025 | — |
| +1 | K250587 | Orthoscan TAU Mini C-Arm | Ziehm-Orthoscan, Inc. | 2025 | — |
| +2 | K252579 | Orthoscan TAU MVP Mini C-Arm System | Ziehm-Orthoscan, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 1 |
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 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 OXO device
- #1 K253296 Digital C-ARM with 3Dscore 15.1 · 13 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 |
|---|---|---|---|
| * | K213113 | Orthoscan Tau Mini C-ArmSummary page 5…ication Names: Image-intensified fluoroscopic x-ray system Product Code: OXO, JAA, MQB Primary Predicate: Orthoscan TAU Mini C-Arm 510(k) Number: K213113 Classification(s): 21CFR 892.1650 Device Class: Class II Classification Names: Image-intensified fluoroscopic x-… | 2021 |
| * | K113708 | Orthoscan Mobile DI Mini C-ArmSummary page 5…es: Image-intensified fluoroscopic x-ray system Product Codes: OXO, JAA, MQB Secondary Predicate: Orthoscan Mobile DI Mini C-Arm 510(k) Number: (K113708) Classification(s): 21CFR 892.1650 Device Class: Class II Classification Names: Image-intensified fluoroscopic x… | 2012 |
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 |
|---|---|---|---|
| K250587 | Orthoscan TAU Mini C-Arm | 2025 | 1 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 3, 2026 | Not classified | Z-0286-2027 | Process control | The accessory cart weldment does not conform to weld dimensional specifications which may result in separation of the monitor arm mounting structure from the cart. |
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 · 7 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- 7 of the 14 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K250587 (Ziehm-Orthoscan, Inc., 2025) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K213113.
How does its category compare?
All OXO devicesOXO Image-Intensified Fluoroscopic X-Ray System, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · OXO
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OXO
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OXO
4in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OXO
118in 2025
MAUDE reports naming product code OXO, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 4 | 48 | 4 | 5 |
| 2013 | 2 | — | 3 | 41 |
| 2014 | 2 | — | 4 | 89 |
| 2015 | 1 | — | 0 | 97 |
| 2016 | 3 | 128 | 3 | 3,820 |
| 2017 | 4 | 57 | 4 | 1,697 |
| 2018 | 1 | — | 11 | 1,647 |
| 2019 | 3 | 213 | 0 | 1,297 |
| 2020 | 0 | — | 0 | 816 |
| 2021 | 2 | — | 0 | 554 |
| 2022 | 0 | — | 0 | 295 |
| 2023 | 0 | — | 0 | 275 |
| 2024 | 2 | — | 4 | 192 |
| 2025 | 4 | 97 | 0 | 118 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Orthoscan VERSA Mini C-arm X-ray system is designed to provide physicians with general fluoroscopic visualization, using pulsed or continuous fluoroscopy, of a patient including but not limited to, diagnostic, surgical, and critical emergency care procedures for patients of all ages including pediatric populations when imaging limbs/extremities, shoulders, at locations including but not limited to, hospitals, ambulatory surgery, emergency, traumatology, orthopedic, critical care, or physician office environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243452 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243452: Orthoscan VERSA Mini C-Arm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243452
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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