FORTE

System, Tomography, Computed, Emission

ADAC LABORATORIES

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

Pre-market Notification Details

• Device ID: K982911
• 510k Number: K982911
• Device Name: FORTE
• Classification: System, Tomography, Computed, Emission
• Applicant: ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035
• Contact: Dennis W Henkelman
• Correspondent: Dennis W Henkelman; ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035
• Product Code: KPS
• CFR Regulation Number: 892.1200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-08-18
• Decision Date: 1998-11-16
• Summary: summary