AutoContour Model RADAC V2

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 Model Radac V2.

Pre-market Notification Details

Device IDK220598
510k NumberK220598
Device Name:AutoContour Model RADAC V2
ClassificationRadiological Image Processing Software For Radiation Therapy
Applicant Radformation, Inc. 335 Madison Avenue, 4th Floor New York,  NY  10017
ContactKurt Sysock
CorrespondentKurt Sysock
Radformation, Inc. 335 Madison Avenue, 4th Floor New York,  NY  10017
Product CodeQKB  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-02
Decision Date2022-08-24

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