GEN-X 800-400 -- MODIFICATION— 510(k) K922813

Name: FDA 510(k) clearance K922813
Creator: U.S. Food and Drug Administration
Published: 1992-08-11

Substantially Equivalent

Swiss Ray Medical Systems

FDA 510(k) clearance K922813 for GEN-X 800-400 -- MODIFICATION, Substantially Equivalent on 1992-08-11. Applicant: Swiss Ray Medical Systems. Device class: 2.

Clearance details

Applicant: Swiss Ray Medical Systems
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 1992-05-22
Decision date: 1992-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mobile, AL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KPR

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K260227 — EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H2026-09-08
K260488 — MULTIX Impact; MULTIX Impact C2026-08-31
K260481 — GC85A2026-08-27
K260482 — DRE Duo2026-06-15
K253446 — AeroDR TX c022026-04-10

More clearances from Swiss Ray Medical Systems

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K921539 — GEN-X 800/6/501992-08-11
K915227 — GEN-X 800/5001992-01-09

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.