GALEN— 510(k) K946334

Substantially Equivalent

Medimage, Inc.

FDA 510(k) clearance K946334 for GALEN, Substantially Equivalent on 1995-03-23. Applicant: Medimage, Inc.. Device class: 2.

Clearance details

Applicant: Medimage, Inc.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 1994-12-29
Decision date: 1995-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.