BEAMSCAN

System, Simulation, Radiation Therapy

VICTOREEN, INC.

The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for Beamscan.

Pre-market Notification Details

• Device ID: K853671
• 510k Number: K853671
• Device Name: BEAMSCAN
• Classification: System, Simulation, Radiation Therapy
• Applicant: VICTOREEN, INC. 100 VOICE RD. Carle Place, NY 11514
• Contact: Glasser
• Correspondent: Glasser; VICTOREEN, INC. 100 VOICE RD. Carle Place, NY 11514
• Product Code: KPQ
• CFR Regulation Number: 892.5840 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-09-04
• Decision Date: 1986-01-10