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 IDK200323
510k NumberK200323
Device Name:AutoContour
ClassificationRadiological Image Processing Software For Radiation Therapy
Applicant Radformation, Inc. 335 Madison Avenue, 16th Floor New York,  NY  10017
ContactKurt Sysock
CorrespondentKurt Sysock
Radformation, Inc. 335 Madison Avenue, 16th Floor New York,  NY  10017
Product CodeQKB  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-10
Decision Date2020-10-30

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