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: K151233
• 510k Number: K151233
• Device Name: Monaco
• Classification: System, Planning, Radiation Therapy Treatment
• Applicant: IMPAC MEDICAL SYSTEMS, INC. 13723 Riverport Drive Suite 100 Maryland Heights, MO 63043
• Contact: Kathryn Stinson
• Correspondent: Kathryn Stinson; IMPAC MEDICAL SYSTEMS, INC. 13723 Riverport Drive Suite 100 Maryland Heights, MO 63043
• Product Code: MUJ
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-05-08
• Decision Date: 2015-07-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00858164002190	K151233	000
00858164002183	K151233	000
00858164002169	K151233	000
00858164002152	K151233	000