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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 K233634
Device Name TeleScan
Applicant
BB Imaging
9701 Brodie Lane, Suite 200
Austin,  TX  78748
Applicant Contact Britt Einspahr
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/13/2023
Decision Date 12/12/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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