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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 K202928
Device Name DV. Target
Applicant
Deepvoxel, Inc.
22 Talisman
Irvine,  CA  92620
Applicant Contact Jerry Liu
Correspondent
Albert Rego, PhD, Inc.
27001 La Paz Rd.
Suite 314
Mission Viejo,  CA  92691
Correspondent Contact Albert Rego
Regulation Number892.2050
Classification Product Code
QKB  
Subsequent Product Code
LLZ  
Date Received09/29/2020
Decision Date 04/02/2021
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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