MINI 6800 DIGITAL MOBILE C-ARM— 510(k) K992506

Substantially Equivalent

Ge Dec Medical Systems

FDA 510(k) clearance K992506 for MINI 6800 DIGITAL MOBILE C-ARM, Substantially Equivalent on 1999-08-19. Applicant: Ge Dec Medical Systems.

Clearance details

Applicant: Ge Dec Medical Systems
Product code: Code OXO
Advisory panel: Radiology
Date received: 1999-07-27
Decision date: 1999-08-19
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OXO

product code OXO

Death: 6
Injury: 163
Malfunction: 2,099
Other: 1
Total: 2,269

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.