GEN-X 800/6/50— 510(k) K921539

Substantially Equivalent

Swiss Ray Medical Systems

FDA 510(k) clearance K921539 for GEN-X 800/6/50, Substantially Equivalent on 1992-08-11. Applicant: Swiss Ray Medical Systems.

Clearance details

Applicant: Swiss Ray Medical Systems
Product code: Code KPR
Advisory panel: Radiology
Date received: 1992-04-01
Decision date: 1992-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mobile, AL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.