# K970063: Series 7600 Mobile Digital C-Arm

- Pathway: 510(k) (Traditional)
- Applicant: Ge Dec Medical Systems
- Decided: Mar 11, 1997 after 63 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) OEC Medical Systems - Compact 7600: named in the summary without a submission number
- (no number) Philips Medical Systems - BV 25 Gold: named in the summary without a submission number
- (no number) Siemens Medical Systems - Siremobil Compact: named in the summary without a submission number

## Recalls of this device
- Sep 28, 2007 · Not classified · Z-0716-2008: Unnecessary operator exposure; X-ray machine may allow unwanted x-ray exposure to the operator.

## Indications for use
The Series 7600 Mobile Digital C-arm is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include, but are not limited to, cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician’s discretion.

Source page: https://510kreport.com/device/K970063
Methodology: https://510kreport.com/methodology