ClearCheck

Accelerator, Linear, Medical

RADFORMATION

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

Pre-market Notification Details

• Device ID: K162468
• 510k Number: K162468
• Device Name: ClearCheck
• Classification: Accelerator, Linear, Medical
• Applicant: RADFORMATION 429 EAST 52ND STREET, UNIT 4G New York, NY 10022
• Contact: Kurt Sysock
• Correspondent: Parul Chansoria; ELEXES 6494 TRALEE VILLAGE DR. Dr Dublin, CA 94568
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-09-02
• Decision Date: 2016-12-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00860001672701	K162468	000