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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K211034
Device Name Corvus Radiation Therapy Planning System
Applicant
Best Nomos
One Best Dr.
Pittsburgh,  PA  15202
Applicant Contact Vineet Gupta
Correspondent
Best Nomos
One Best Dr.
Pittsburgh,  PA  15202
Correspondent Contact Vineet Gupta
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received04/07/2021
Decision Date 05/06/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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