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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Digital Pathology Image Viewing And Management Software
510(k) Number K261380
Device Name Concentriq AP-Dx
Applicant
Proscia, Inc.
1700 Market St.
Floor 24
Philadelphia,  PA  19103
Applicant Contact Ian Cadieux
Correspondent
Proscia, Inc.
1700 Market St.
Floor 24
Philadelphia,  PA  19103
Correspondent Contact Ian Cadieux
Regulation Number864.3700
Classification Product Code
QKQ  
Date Received04/27/2026
Decision Date 08/05/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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