Radiance 330 Proton Beam Therapy System

System, Radiation Therapy, Charged-particle, Medical

ProTom International Holding Corporation

The following data is part of a premarket notification filed by Protom International Holding Corporation with the FDA for Radiance 330 Proton Beam Therapy System.

Pre-market Notification Details

• Device ID: K191521
• 510k Number: K191521
• Device Name: Radiance 330 Proton Beam Therapy System
• Classification: System, Radiation Therapy, Charged-particle, Medical
• Applicant: ProTom International Holding Corporation 500 Edgewater Place Suite 522 Wakefield, MA 01880
• Contact: Stephen L. Spotts
• Correspondent: Jonathan Kahan; Hogan Lovells US LLP 555 Thirteenth Street NW Washington, DC 20004
• Product Code: LHN
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-06-07
• Decision Date: 2019-09-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00861552000418	K191521	000