GEN-X 800/500— 510(k) K915227

Substantially Equivalent

Swiss Ray Medical Systems

FDA 510(k) clearance K915227 for GEN-X 800/500, Substantially Equivalent on 1992-01-09. Applicant: Swiss Ray Medical Systems. Device class: 1.

Clearance details

Applicant: Swiss Ray Medical Systems
Product code: Code IZO
Device class: Class 1
Regulation: 21 CFR 892.1700
Advisory panel: Radiology
Date received: 1991-11-20
Decision date: 1992-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mobile, AL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IZO

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K953582 — HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR1995-09-26
K953831 — N 800 HF1995-09-08
K952822 — SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G1995-07-12
K952265 — MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR1995-07-06

More clearances from Swiss Ray Medical Systems

K921539 — GEN-X 800/6/501992-08-11
K922813 — GEN-X 800-400 -- MODIFICATION1992-08-11

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