GALEN

System, Tomography, Computed, Emission

MEDIMAGE, INC.

The following data is part of a premarket notification filed by Medimage, Inc. with the FDA for Galen.

Pre-market Notification Details

• Device ID: K946334
• 510k Number: K946334
• Device Name: GALEN
• Classification: System, Tomography, Computed, Emission
• Applicant: MEDIMAGE, INC. 6276 JACKSON RD. STE. G Ann Arbor, MI 48103 -9579
• Contact: William C Forgacs
• Correspondent: William C Forgacs; MEDIMAGE, INC. 6276 JACKSON RD. STE. G Ann Arbor, MI 48103 -9579
• Product Code: KPS
• CFR Regulation Number: 892.1200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-12-29
• Decision Date: 1995-03-23