OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE— 510(k) K973793

Name: FDA 510(k) clearance K973793
Creator: U.S. Food and Drug Administration
Published: 1997-12-17

Substantially Equivalent

Olicon Imaging Systems, Inc.

FDA 510(k) clearance K973793 for OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE, Substantially Equivalent on 1997-12-17. Applicant: Olicon Imaging Systems, Inc.. Device class: 1.

Clearance details

Applicant: Olicon Imaging Systems, Inc.
Product code: Code LMD
Device class: Class 1
Regulation: 21 CFR 892.2020
Advisory panel: Radiology
Date received: 1997-10-06
Decision date: 1997-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plano, TX, US

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