VISION FX 40 & 80 SERIES GAMMA CAMERA— 510(k) K935273

Name: FDA 510(k) clearance K935273
Creator: U.S. Food and Drug Administration
Published: 1994-04-18

Substantially Equivalent

Summit Nuclear

FDA 510(k) clearance K935273 for VISION FX 40 & 80 SERIES GAMMA CAMERA, Substantially Equivalent on 1994-04-18. Applicant: Summit Nuclear. Device class: 1.

Clearance details

Applicant: Summit Nuclear
Product code: Code IYX
Device class: Class 1
Regulation: 21 CFR 892.1100
Advisory panel: Radiology
Date received: 1993-11-02
Decision date: 1994-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Twinsburg, OH, US

Download summary PDF View on FDA.gov ↗

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