ChartCheck

Accelerator, Linear, Medical

Radformation, Inc.

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

Pre-market Notification Details

• Device ID: K201119
• 510k Number: K201119
• Device Name: ChartCheck
• Classification: Accelerator, Linear, Medical
• 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: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-04-27
• Decision Date: 2020-06-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00860001672749	K201119	000