GAMMACON IMAGE TRANSLATION SYSTEM— 510(k) K962955

Name: FDA 510(k) clearance K962955
Creator: U.S. Food and Drug Administration
Published: 1996-10-28

Substantially Equivalent

Medical Imaging Technology Assoc., Inc.

FDA 510(k) clearance K962955 for GAMMACON IMAGE TRANSLATION SYSTEM, Substantially Equivalent on 1996-10-28. Applicant: Medical Imaging Technology Assoc., Inc.. Device class: 2.

Clearance details

Applicant: Medical Imaging Technology Assoc., Inc.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 1996-07-30
Decision date: 1996-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mainland, PA, US

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