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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Computer-Assisted Prioritization Software For Lesions
510(k) Number K231871
Device Name Radify Triage
Applicant
Envisionit Deepai, Ltd.
Coveham House
Downside Bridge Rd.
Cobham,  GB KT11 3EP
Applicant Contact Jaishree Naidoo
Correspondent
Hardian Ltd T/A Hardian Health
C/O Galloways, 3rd Floor
21 Perrymount Rd.
Haywards Heath,  GB RH16 3TP
Correspondent Contact Michael Pogose
Regulation Number892.2080
Classification Product Code
QFM  
Date Received06/26/2023
Decision Date 01/17/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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