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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 K201350
Device Name CORVUS
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 Received05/21/2020
Decision Date 09/20/2020
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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