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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name whole slide imaging system
510(k) Number K230839
Device Name Concentriq Dx
Applicant
Proscia, Inc.
1700 Market St.
23rd Floor
Philadelphia,  PA  19103
Applicant Contact Kim Rendon
Correspondent
Proscia, Inc.
1700 Market St.
23rd Floor
Philadelphia,  PA  19103
Correspondent Contact Kim Rendon
Regulation Number864.3700
Classification Product Code
PSY  
Subsequent Product Code
QKQ  
Date Received03/27/2023
Decision Date 02/08/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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