AutoContour

Radiological Image Processing Software For Radiation Therapy

Radformation, Inc.

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

Pre-market Notification Details

• Device ID: K200323
• 510k Number: K200323
• Device Name: AutoContour
• Classification: Radiological Image Processing Software For Radiation Therapy
• 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: QKB
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-02-10
• Decision Date: 2020-10-30

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00860001672732	K200323	000