ICON

System, Tomographic, Nuclear

SIEMENS GAMMASONICS, INC.

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

Pre-market Notification Details

• Device ID: K903315
• 510k Number: K903315
• Device Name: ICON
• Classification: System, Tomographic, Nuclear
• Applicant: SIEMENS GAMMASONICS, INC. 2501 N. BARRINGTON RD. Hoffman Estates, IL 60195 -7372
• Contact: Dennis W Henkelman
• Correspondent: Dennis W Henkelman; SIEMENS GAMMASONICS, INC. 2501 N. BARRINGTON RD. Hoffman Estates, IL 60195 -7372
• Product Code: JWM
• CFR Regulation Number: 892.1310 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-07-24
• Decision Date: 1991-01-09