MITRA IMAGING, INC. FILM EXPRESS SCANNING SOFTWARE— 510(k) K970652

Name: FDA 510(k) clearance K970652
Creator: U.S. Food and Drug Administration
Published: 1997-05-02

Substantially Equivalent

Mitra Imaging, Inc.

FDA 510(k) clearance K970652 for MITRA IMAGING, INC. FILM EXPRESS SCANNING SOFTWARE, Substantially Equivalent on 1997-05-02. Applicant: Mitra Imaging, Inc.. Device class: 1.

Clearance details

Applicant: Mitra Imaging, Inc.
Product code: Code LMD
Device class: Class 1
Regulation: 21 CFR 892.2020
Advisory panel: Radiology
Date received: 1997-02-21
Decision date: 1997-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waterloo, Ontario, CA

Download summary PDF View on FDA.gov ↗

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