RADIANCE

System, Planning, Radiation Therapy Treatment

GMV AEROSPACE AND DEFENCE S.A.

The following data is part of a premarket notification filed by Gmv Aerospace And Defence S.a. with the FDA for Radiance.

Pre-market Notification Details

• Device ID: K112060
• 510k Number: K112060
• Device Name: RADIANCE
• Classification: System, Planning, Radiation Therapy Treatment
• Applicant: GMV AEROSPACE AND DEFENCE S.A. 220 RIVER ROAD Claremont, NH 03743
• Contact: William Greenrose
• Correspondent: William Greenrose; GMV AEROSPACE AND DEFENCE S.A. 220 RIVER ROAD Claremont, NH 03743
• Product Code: MUJ
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-07-19
• Decision Date: 2012-01-06
• Summary: summary