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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Image Processing Software For Radiation Therapy
510(k) Number K203610
Device Name Automatic Anatomy Recognition (AAR)
Applicant
Quantitative Radiology Solutions, LLC
3675 Market St., Suite 200
Philadelphia,  PA  19104
Applicant Contact Steve Owens
Correspondent
Medical Device Academy
345
Lincoln Hill Rd.
Shrewsbury,  VT  05738
Correspondent Contact Mary Vater
Regulation Number892.2050
Classification Product Code
QKB  
Date Received12/10/2020
Decision Date 04/20/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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