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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 K231351
Device Name Chondral Quant
Applicant
Siemens Medical Soultions USA, Inc.
40 Liberty Blvd.
Malvern,  PA  19335
Applicant Contact Milind Dhamankar
Correspondent
Siemens Medical Soultions USA, Inc.
40 Liberty Blvd.
Malvern,  PA  19335
Correspondent Contact Milind Dhamankar
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
LNH  
Date Received05/09/2023
Decision Date 07/13/2023
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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