VIEWPOINT

System, Image Processing, Radiological

ADAC LABORATORIES

The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Viewpoint.

Pre-market Notification Details

• Device ID: K882205
• 510k Number: K882205
• Device Name: VIEWPOINT
• Classification: System, Image Processing, Radiological
• Applicant: ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035
• Contact: Larry Hernandez
• Correspondent: Larry Hernandez; ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1988-05-26
• Decision Date: 1988-08-11