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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 K223032
Device Name SIS System (Version 5.6.0)
Applicant
Surgical Information Sciences, Inc.
4602 141st Ln NE
Ham Lake,  MN  55304
Applicant Contact Ann Quinlan-Smith
Correspondent
Hogan Lovells US LLP
1735 Market St.,
23rd Floor
Philadelphia,  PA  19103
Correspondent Contact Kelliann H Payne
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received09/29/2022
Decision Date 11/21/2022
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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