UNISCAN

System, Digital Image Communications, Radiological

MERLIN ENGINEERING WORKS, INC.

The following data is part of a premarket notification filed by Merlin Engineering Works, Inc. with the FDA for Uniscan.

Pre-market Notification Details

• Device ID: K953398
• 510k Number: K953398
• Device Name: UNISCAN
• Classification: System, Digital Image Communications, Radiological
• Applicant: MERLIN ENGINEERING WORKS, INC. 1888 EMBARCADERO RD. Palo Alto, CA 94303
• Contact: Generald Engbreston
• Correspondent: Generald Engbreston; MERLIN ENGINEERING WORKS, INC. 1888 EMBARCADERO RD. Palo Alto, CA 94303
• Product Code: LMD
• CFR Regulation Number: 892.2020 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-07-20
• Decision Date: 1995-10-06