510(k) · Cleared
ClearedInsight - FD Mini C-Arm Fluoroscopic Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Cleared on Apr 6, 2012 as substantially equivalent to K051754 (Orthoscan, Inc., 2005) and 2 other predicates after a 59-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Apr 6, 2012
- Review
- 59 days
- Class
- Class II
- Product code
- OXO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K974058 (1998). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K974058 | FS IV Mini C-Arm System | Hologic, Inc. | 1998 | — |
| −1 | K051025 | Fluoroscan Insight Mini C-Arm Fluoroscopic Imaging System | Hologic, Inc. | 2005 | 4 |
| 0 (this device) | K120388 | Insight - FD Mini C-Arm Fluoroscopic Imaging System | Hologic, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K051754 | Orthoscan, Orthoscan HDSummary page 2…y System, 21 CFR 892.1650 3.3 Classification Panel Radiology 3.4 Product Code oxo 3.5 Predicate Devices * 510(k) No: K051754 Trade Name: Orthoscan, OrthoScan HD (which includes OrthoScan HO with Flat Detector) SE Date: 8/9/2… | 2005 |
| * | K113708 | Orthoscan Mobile DI Mini C-ArmSummary page 2…hoscan, OrthoScan HD (which includes OrthoScan HO with Flat Detector) SE Date: 8/9/2005 Manufacturer: Orthoscan, Inc. * 510(k) No: K113708 Trade Name: Orthoscan Mobile Dl SE Date: 1/5/2012 Manufacturer: Orthoscan, Inc. " 510(k) N… | 2012 |
| * | K051025 | Fluoroscan Insight Mini C-Arm Fluoroscopic Imaging SystemSummary page 2…n, Inc. * 510(k) No: K113708 Trade Name: Orthoscan Mobile Dl SE Date: 1/5/2012 Manufacturer: Orthoscan, Inc. " 510(k) No: K051025 Trade Name: Fluoroscan InSight Mini C-Arm Fluoroscopic Imaging System SE Date: 5/13/2005 Manufactur… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 1 company; a new generation was cleared every 7.3 years on median.
- 3 of the 4 ancestors have a recall of any class.
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 Fluoroscan InSight is a Mini C-Arm Fluoroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including, but not limited to surgical orthopedic and podiatry use, critical and emergency care procedures, and light anatomy imaging situations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120388 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120388: Insight - FD Mini C-Arm Fluoroscopic Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120388
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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