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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 K253421
Device Name Perfusion Measurement Platform v1
Applicant
Quantified Imaging Limited
23 Alphabet Mews
Unit Z
London,  GB SW113HU
Applicant Contact Armen Bodossian
Correspondent
Quantified Imaging Limited
23 Alphabet Mews
Unit Z
London,  GB SW90FN
Correspondent Contact Armen Bodossian
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/01/2025
Decision Date 06/22/2026
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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