510(k) · Cleared
Recalled · Class II · 2017Orthoscan FD 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 Mar 28, 2014 after a 162-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it. It has been recalled once.
- Decided
- Mar 28, 2014
- Review
- 162 days
- Class
- Class II
- Product code
- OXO
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK133174 Orthoscan FD Mini C-ArmOrthoscan, Inc. · 2014
- 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 · 3 generations on · 1 of its ownK250587 Orthoscan TAU Mini C-ArmZiehm-Orthoscan, Inc. · 2025
- Descendant · 4 generations on · 0 of its ownK252579 Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc. · 2026
Most influential descendants
Showing 5 of 5 · 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
- K250587Orthoscan TAU Mini C-ArmZiehm-Orthoscan, Inc. · 2025 · 3 generations on1descendant
- K252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K133174 | Orthoscan FD Mini C-Arm | Orthoscan, Inc. | 2014 | — |
| +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 |
| +3 | K250587 | Orthoscan TAU Mini C-Arm | Ziehm-Orthoscan, Inc. | 2025 | — |
| +4 | K252579 | Orthoscan TAU MVP Mini C-Arm System | Ziehm-Orthoscan, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183220 | OrthoScan TAU Mini C-Arm | 2019 | 4 |
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-0261-2018 | 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, K183220 (Orthoscan, Inc., 2019) has gone furthest, with 4 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. 2014, 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 | — |
https://510kreport.com/device/K133174 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133174: Orthoscan FD 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/K133174
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026