RADVISION

System, Planning, Radiation Therapy Treatment

ACOUSTIC MEDSYSTEMS, INC.

The following data is part of a premarket notification filed by Acoustic Medsystems, Inc. with the FDA for Radvision.

Pre-market Notification Details

• Device ID: K131428
• 510k Number: K131428
• Device Name: RADVISION
• Classification: System, Planning, Radiation Therapy Treatment
• Applicant: ACOUSTIC MEDSYSTEMS, INC. 208 BURWASH AVE. Savoy, IL 61874
• Contact: Jennifer Williams
• Correspondent: Jennifer Williams; ACOUSTIC MEDSYSTEMS, INC. 208 BURWASH AVE. Savoy, IL 61874
• Product Code: MUJ
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-05-17
• Decision Date: 2013-07-16
• Summary: summary