FREEPIX/PIXPACS DICOM/HTTP GATEWAY— 510(k) K970174

Name: FDA 510(k) clearance K970174
Creator: U.S. Food and Drug Administration
Published: 1997-05-01

Substantially Equivalent

Pixelinks, Inc.

FDA 510(k) clearance K970174 for FREEPIX/PIXPACS DICOM/HTTP GATEWAY, Substantially Equivalent on 1997-05-01. Applicant: Pixelinks, Inc.. Device class: 1.

Clearance details

Applicant: Pixelinks, Inc.
Product code: Code LMD
Device class: Class 1
Regulation: 21 CFR 892.2020
Advisory panel: Radiology
Date received: 1997-01-10
Decision date: 1997-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morristown, NJ, US

Download summary PDF View on FDA.gov ↗

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