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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K191262
Device Name aBSI
Applicant
EXINI Diagnostics AB
Ideon Science Park, Scheelevagen 27
Lund,  SE se-223 70
Applicant Contact Aseem Anand
Correspondent
Biologics Consulting
1555 King Street, Suite 300
Alexandria,  VA  22314
Correspondent Contact Donna-Bea Tillman
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/10/2019
Decision Date 08/05/2019
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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