510(k) · Cleared
Recalled · Class II · 2017Orthoscan Mobile DI Mini C-Arm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthoscan, Inc. · OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Cleared on Jan 5, 2012 after a 20-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it. It has been recalled once.
- Decided
- Jan 5, 2012
- Review
- 20 days
- Class
- Class II
- Product code
- OXO
- Recalls
- 1
- Predicates
- 0
7 later devices descend from it, 4 citing it directly.
- This deviceK113708 Orthoscan Mobile DI Mini C-ArmOrthoscan, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK243452 Orthoscan VERSA Mini C-ArmZiehm-Orthoscan, Inc. · 2025 · Recalled
- Descendant · 2 generations on · 1 of its ownK250587 Orthoscan TAU Mini C-ArmZiehm-Orthoscan, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK221949 Ortho Device, ADAPTIX 3D Orthopedic Imaging SystemPausch Medical GmbH · 2023
- Descendant · 3 generations on · 0 of its ownK252579 Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK252133 Adaptix Ortho350Adaptix Limited · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K243452Orthoscan VERSA Mini C-ArmZiehm-Orthoscan, Inc. · 2025 · cites it directly2descendants
- K250587Orthoscan TAU Mini C-ArmZiehm-Orthoscan, Inc. · 2025 · 2 generations on1descendant
- K221949Ortho Device, ADAPTIX 3D Orthopedic Imaging SystemPausch Medical GmbH · 2023 · cites it directly1descendant
- K252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc. · 2026 · 3 generations on0descendants
- K252133Adaptix Ortho350Adaptix Limited · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K113708 | Orthoscan Mobile DI Mini C-Arm | Orthoscan, Inc. | 2012 | — |
| +1 | K243452 | Orthoscan VERSA Mini C-Arm | Ziehm-Orthoscan, Inc. | 2025 | 1 |
| +2 | K250587 | Orthoscan TAU Mini C-Arm | Ziehm-Orthoscan, Inc. | 2025 | — |
| +1 | K221949 | Ortho Device, ADAPTIX 3D Orthopedic Imaging System | Pausch Medical GmbH | 2023 | — |
| +3 | K252579 | Orthoscan TAU MVP Mini C-Arm System | Ziehm-Orthoscan, Inc. | 2026 | — |
| +2 | K252133 | Adaptix Ortho350 | Adaptix Limited | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OXO? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 31, 2017 | Class II | Z-0260-2018 | Software design | OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom feature in the course of taking a live image exposing… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K243452 (Ziehm-Orthoscan, Inc., 2025) has gone furthest, with 2 descendants of its own.
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. 2012, 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 Mobile DI Mini C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures in hospital, emergency care, critical care, or physician office environments.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K113708 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113708: Orthoscan Mobile DI Mini C-Arm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113708
Report an extraction error
Are you the manufacturer?
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