# K051025: Fluoroscan Insight Mini C-Arm Fluoroscopic Imaging System

- Pathway: 510(k) (Special)
- Applicant: Hologic, Inc.
- Decided: May 13, 2005 after 21 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K974058 (1998). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974058: FS IV Mini C-Arm System, Hologic, Inc. (1998) Summary page 1.

## Most influential descendants
- K120388: Insight - FD Mini C-Arm Fluoroscopic Imaging System (2012), 0 descendants of its own

## Recalls of this device
- Apr 25, 2013 · Class II · Z-1327-2013: The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate and the total cumulative irradiation time is not accurate.
- Apr 25, 2013 · Class II · Z-1326-2013: The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate and the total cumulative irradiation time is not accurate.
- Sep 14, 2012 · Class II · Z-2452-2012: InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180¿around vertical axis. InSight FD, version 5.0.1 and 5.0.2 - DICOM images stored in PACS may be lipped 180¿ around verti
- Sep 14, 2012 · Class II · Z-2453-2012: Fluoroscan Mini C-Arm models -InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180¿around vertical axis. InSight FD, version 5.0.1 and 5.0.2 - DICOM images stored in PACS m

## 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/K051025
Methodology: https://510kreport.com/methodology