AI-Rad Companion Organs RT

Radiological Image Processing Software For Radiation Therapy

Siemens Medical Solutions USA, Inc.

The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Ai-rad Companion Organs Rt.

Pre-market Notification Details

Device IDK193562
510k NumberK193562
Device Name:AI-Rad Companion Organs RT
ClassificationRadiological Image Processing Software For Radiation Therapy
Applicant Siemens Medical Solutions USA, Inc. 40 Liberty Blvd. Mail Code 65-3 Malvern,  PA  19355
ContactLauren Bentley
CorrespondentLauren Bentley
Siemens Medical Solutions USA, Inc. 40 Liberty Blvd. Mail Code 65-3 Malvern,  PA  19355
Product CodeQKB  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-23
Decision Date2020-11-06

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