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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 K240642
Device Name SMART Bun-Yo-Matic CT
Applicant
Disior Ltd
HTC Helsinki, Building Pinta, Tammasaarenkatu 3
Helsinki Uusimaa,  FI 00180
Applicant Contact Aarno Jussila
Correspondent
Paragon 28, Inc.
14445 Grasslands Dr.
Englewood,  CO  80134
Correspondent Contact Haylie Fast
Regulation Number892.2050
Classification Product Code
QIH  
Date Received03/06/2024
Decision Date 06/20/2024
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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