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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K253794
Device Name Prostate Core
Applicant
Lucida Medical, Ltd.
Future Business Centre
King'S Hedges Rd.
Cambridge,  GB CB4 2HY
Applicant Contact Toby Davis
Correspondent
Lucida Medical, Ltd.
Future Business Centre
King'S Hedges Rd.
Cambridge,  GB CB4 2HY
Correspondent Contact Toby Davis
Regulation Number892.2050
Classification Product Code
QIH  
Date Received11/28/2025
Decision Date 08/10/2026
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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