ClearCalc

System, Planning, Radiation Therapy Treatment

Radformation, Inc.

The following data is part of a premarket notification filed by Radformation, Inc. with the FDA for Clearcalc.

Pre-market Notification Details

• Device ID: K193640
• 510k Number: K193640
• Device Name: ClearCalc
• Classification: System, Planning, Radiation Therapy Treatment
• Applicant: Radformation, Inc. 335 Madison Avenue, 16th Floor New York, NY 10017
• Contact: Kurt Sysock
• Correspondent: Kurt Sysock; Radformation, Inc. 335 Madison Avenue, 16th Floor New York, NY 10017
• Product Code: MUJ
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-12-27
• Decision Date: 2020-04-09

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00860001672725	K193640	000