GALEN— 510(k) K946334

Substantially Equivalent

Medimage, Inc.

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

Clearance details

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

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