# K974058: FS IV Mini C-Arm System

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Jan 12, 1998 after 77 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- 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
No predicates in its family tree.
2 later devices descend 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)
- None. The FDA summary names its predicate without a number.
- (no number) Fluoroscan III Mini C-arm System: named in the summary without a submission number
- (no number) OEC Series 6600 Digital Mobile C-arm: named in the summary without a submission number
- (no number) XiScan Dual Digital Mini C-arm: named in the summary without a submission number
- (no number) Lunar ORCA Orthopedic C-arm: named in the summary without a submission number

## Most influential descendants
- K051025: Fluoroscan Insight Mini C-Arm Fluoroscopic Imaging System (2005), 1 descendant of its own
- K120388: Insight - FD Mini C-Arm Fluoroscopic Imaging System (2012), 0 descendants of its own

## Indications for use
The FS IV Mini C-arm system is designed to provide physicians with general fluoroscopic visualization of a patient including, but not limited to, surgical orthopedic and podiatric, critical and emergency care procedures and light anatomy imaging situations.

Source page: https://510kreport.com/device/K974058
Methodology: https://510kreport.com/methodology