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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 K252332
Device Name Folliscan
Applicant
Mim Fertility
Bitwy Warszawskiej 1920 R. 7b 02-366
Warszawa,  PL
Applicant Contact Ula Sankowska
Correspondent
Prime Path Medtech
1321 Upland Dr.
Suite 6792
Houston,  TX  77043
Correspondent Contact Mariel Chavez
Regulation Number892.2050
Classification Product Code
QIH  
Date Received07/25/2025
Decision Date 04/20/2026
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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