510(k) · Cleared
Recalled · Class II · 2017Orthoscan, Orthoscan HD
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 Aug 9, 2005 after a 41-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Aug 9, 2005
- Review
- 41 days
- Class
- Class II
- Product code
- OXO
- Recalls
- 2
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK051754 Orthoscan, Orthoscan HDOrthoscan, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK120388 Insight - FD Mini C-Arm Fluoroscopic Imaging SystemHologic, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K120388Insight - FD Mini C-Arm Fluoroscopic Imaging SystemHologic, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051754 | Orthoscan, Orthoscan HD | Orthoscan, Inc. | 2005 | — |
| +1 | K120388 | Insight - FD Mini C-Arm Fluoroscopic Imaging System | Hologic, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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.
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? (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 |
|---|---|---|---|
| * | — | GE/OEC Medical Systems series 6800 mini view digital mobile imaging device Named without a submission number | |
| * | — | Hologic/FluoroScan Imaging System Premier Encore mobile imaging device Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120388 | Insight - FD Mini C-Arm Fluoroscopic Imaging System | 2012 | 0 |
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-0258-2018 | 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… |
| Aug 31, 2017 | Class II | Z-0259-2018 | 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, K120388 (Hologic, Inc., 2012) has gone furthest, with 0 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.
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 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.
The intended users of this product are doctors surgeons, radiologists and technologists who will use this product in a hospital or clinical environment. It is anticipated that the majority of user will be orthopedic doctors, podiatrists and pediatricians, among others.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051754 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051754: Orthoscan, Orthoscan HD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051754
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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