# K120388: Insight - FD Mini C-Arm Fluoroscopic Imaging System

- Pathway: 510(k) (Special)
- Applicant: Hologic, Inc.
- Decided: Apr 6, 2012 after 59 days
- Product code: OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K974058 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051754: Orthoscan, Orthoscan HD, Orthoscan, Inc. (2005) Summary page 2.
- K113708: Orthoscan Mobile DI Mini C-Arm, Orthoscan, Inc. (2012) Summary page 2.
- K051025: Fluoroscan Insight Mini C-Arm Fluoroscopic Imaging System, Hologic, Inc. (2005) Summary page 2.

## Indications for use
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.

Source page: https://510kreport.com/device/K120388
Methodology: https://510kreport.com/methodology