MONACO

System, Planning, Radiation Therapy Treatment

IMPAC MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Impac Medical Systems, Inc. with the FDA for Monaco.

Pre-market Notification Details

• Device ID: K132971
• 510k Number: K132971
• Device Name: MONACO
• Classification: System, Planning, Radiation Therapy Treatment
• Applicant: IMPAC MEDICAL SYSTEMS, INC. 13723 Riverport Drive Suite 100 Maryland Heights, MO 63139
• Contact: Kathryn Stinson
• Correspondent: Kathryn Stinson; IMPAC MEDICAL SYSTEMS, INC. 13723 Riverport Drive Suite 100 Maryland Heights, MO 63139
• Product Code: MUJ
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-09-23
• Decision Date: 2013-11-20
• Summary: summary