Automatic Anatomy Recognition (AAR)

Radiological Image Processing Software For Radiation Therapy

Quantitative Radiology Solutions, LLC

The following data is part of a premarket notification filed by Quantitative Radiology Solutions, Llc with the FDA for Automatic Anatomy Recognition (aar).

Pre-market Notification Details

Device IDK203610
510k NumberK203610
Device Name:Automatic Anatomy Recognition (AAR)
ClassificationRadiological Image Processing Software For Radiation Therapy
Applicant Quantitative Radiology Solutions, LLC 3675 Market Street, Suite 200 Philadelphia,  PA  19104
ContactSteve Owens
CorrespondentMary Vater
Medical Device Academy 345 Lincoln Hill Rd. Shrewsbury,  VT  05738
Product CodeQKB  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-10
Decision Date2021-04-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860006956004 K203610 000

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