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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 K223855
Device Name FEops HEARTguideTM, FEops HEARTguideTM ALPACA
Applicant
FEops nv
Technologiepark 122
Gent-Zwijnaarde,  BE 9052
Applicant Contact Peter Mortier
Correspondent
OrthoGrow nv
Davincilaan 1
Zaventem,  BE 1930
Correspondent Contact Mieke Janssen
Regulation Number892.2050
Classification Product Code
QIH  
Date Received12/23/2022
Decision Date 06/06/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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