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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K253899
Device Name 3D-Anywhere
Applicant
Provect.AI
115 Lancewood Pl.
Los Gatos,  CA  95032
Applicant Contact Dorian Averbuch
Correspondent
ProMedic Consulting, LLC
131 Bay Pt. Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/05/2025
Decision Date 07/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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