BODYSCAN

Camera, Scintillation (gamma)

SIEMENS GAMMASONICS, INC.

The following data is part of a premarket notification filed by Siemens Gammasonics, Inc. with the FDA for Bodyscan.

Pre-market Notification Details

• Device ID: K870818
• 510k Number: K870818
• Device Name: BODYSCAN
• Classification: Camera, Scintillation (gamma)
• Applicant: SIEMENS GAMMASONICS, INC. 2000 NUCLEAR DR. Des Plaines, IL 60018
• Contact: Joseph P Stowell
• Correspondent: Joseph P Stowell; SIEMENS GAMMASONICS, INC. 2000 NUCLEAR DR. Des Plaines, IL 60018
• Product Code: IYX
• CFR Regulation Number: 892.1100 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1987-03-03
• Decision Date: 1987-03-16