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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 K240736
Device Name SMART Bun-Yo-Matic X-Ray
Applicant
Disior, Ltd.
Htc Helsinki, Bldg. Pinta, Tammasaarenkatu 3
Helsinki Uusimaa,  FI 00180
Applicant Contact Aamo Jussila
Correspondent
Paragon 28, Inc.
14445 Grasslands Dr.
Englewood,  CO  80134
Correspondent Contact Haylie Fast
Regulation Number892.2050
Classification Product Code
QIH  
Date Received03/18/2024
Decision Date 07/02/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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