RADWORKS MEDICAL IMAGING SOFTWARE— 510(k) K962699

Name: FDA 510(k) clearance K962699
Creator: U.S. Food and Drug Administration
Published: 1996-08-19

Substantially Equivalent

Applicare Medical Imaging, B.V.

FDA 510(k) clearance K962699 for RADWORKS MEDICAL IMAGING SOFTWARE, Substantially Equivalent on 1996-08-19. Applicant: Applicare Medical Imaging, B.V.. Device class: 1.

Clearance details

Applicant: Applicare Medical Imaging, B.V.
Product code: Code LMD
Device class: Class 1
Regulation: 21 CFR 892.2020
Advisory panel: Radiology
Date received: 1996-07-11
Decision date: 1996-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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