Concentriq AP-Dx-US

FDA UDI

Class II (US FDA UDI)

by Proscia, Inc.

Identity

Trade Name: Concentriq AP-Dx-US FDA UDI
Generic Name: Laboratory instrument/analyser application software IVD FDA UDI
Device Name: Concentriq® AP-Dx is a software only device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret and manage these digital slide images for the purpose of primary diagnosis. Concentriq AP-Dx is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens. FDA UDI
Model / Reference: 4.6 FDA UDI
Description: Concentriq® AP-Dx is a software only device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret and manage these digital slide images for the purpose of primary diagnosis. Concentriq AP-Dx is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens. FDA UDI

Identifiers

Catalog Number: US FDA UDI
Primary DI / UDI-DI: 00860006054557 FDA UDI
510(k) Number: K230839 FDA UDI
FDA Product Code: QKQ FDA UDI
PSY FDA UDI
GMDN Term: Laboratory instrument/analyser application software IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.3700 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Concentriq AP-Dx-US by Proscia, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K230839 also covers:

Concentriq AP-Dx — Proscia, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Proscia, Inc.

Sources (1)

FDA UDI 684a098f-c87c-4f6f-aa9c-c90dbb0e79b8 37 fields · synced Jun 1, 2026