SUMMIT NUCLEAR VISION FX 20 SERIES GAMMA CAMERA SYSTEMS— 510(k) K935318

Name: FDA 510(k) clearance K935318
Creator: U.S. Food and Drug Administration
Published: 1994-02-25

Substantially Equivalent

Summit Nuclear

FDA 510(k) clearance K935318 for SUMMIT NUCLEAR VISION FX 20 SERIES GAMMA CAMERA SYSTEMS, Substantially Equivalent on 1994-02-25. Applicant: Summit Nuclear. Device class: 2.

Clearance details

Applicant: Summit Nuclear
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 1993-11-04
Decision date: 1994-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Twinsburg, OH, US

Download summary PDF View on FDA.gov ↗

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