# K963952: Series 9600 Mobile Digital Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Ge Dec Medical Systems
- Decided: Dec 23, 1996 after 82 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 - Series 9600 Mobile Digital Imaging System [original 510(k) device]: named in the summary without a submission number
- (no number) Philips Medical Systems - BV 29 Mobile Imaging System: named in the summary without a submission number
- (no number) Philips Medical Systems - BV 212 Mobile Imaging System: named in the summary without a submission number

## Recalls of this device
- Jul 2, 2008 · Not classified · Z-1709-2008: Secondary collimator filters may be missing on certain x-ray units. It was discovered that the secondary collimator filter on some OEC 9600 C-arms was omitted when a collimator assembly was replaced. 

## Indications for use
The Series 9600 Mobile Digital Imaging System 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/K963952
Methodology: https://510kreport.com/methodology