# K980322: Accent 16, Accent 22

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Apr 24, 1998 after 87 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
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) STENOSCOP 2, Model 60C0: named in the summary without a submission number
- (no number) STENOSCOP 2, Model 9000: named in the summary without a submission number

## Indications for use
The ACCENT systems are mobile image-intensified fluoroscopic x-ray systems, intended for use in general surgical procedures such as orthopedics, traumatology, visceral surgery, pacemaker implants, urology, etc. or other interventional procedures.

Source page: https://510kreport.com/device/K980322
Methodology: https://510kreport.com/methodology