Identity
- Trade Name
- Concentriq AP-Dx FDA UDI
- Generic Name
- Laboratory instrument/analyser application software IVD FDA UDI
- Device Name
- Concentriq AP-Dx is a diagnostic software device for viewing and managing digital pathology slides from FFPE tissue. It aids pathologists in reviewing and interpreting digital slide images for primary diagnosis, specifically with Hamamatsu NanoZoomer S360MD scanner and JVC monitor. The software requires qualified pathologists to ensure image quality and interpretation validity. Not intended for frozen sections, cytology, or non-FFPE hematopathology specimens. FDA UDI
- Model / Reference
- DX040US FDA UDI
- Description
- Concentriq AP-Dx is a diagnostic software device for viewing and managing digital pathology slides from FFPE tissue. It aids pathologists in reviewing and interpreting digital slide images for primary diagnosis, specifically with Hamamatsu NanoZoomer S360MD scanner and JVC monitor. The software requires qualified pathologists to ensure image quality and interpretation validity. Not intended for frozen sections, cytology, or non-FFPE hematopathology specimens. FDA UDI
Identifiers
- Catalog Number
- 4.8.1 FDA UDI
- Primary DI / UDI-DI
- 00860006054595 FDA UDI
- 510(k) Number
- K230839 FDA UDI
- FDA Product Code
- 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
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Laboratory instrument/analyser application software IVD
Concentriq AP-Dx by Proscia, Inc. — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Laboratory instrument/analyser application software IVD.
- Alinity — Abbott · Class I
- Navios Analysis Software — BECKMAN COULTER IRELAND INC. · Class II
- Alinity — Abbott · Class I
- ARCHITECT — Abbott Laboratories, Inc. · Class I
- RealTime — Abbott Molecular · Class II
- Alinity — Abbott · Class I
- ARCHITECT — Abbott Laboratories, Inc. · Class I
- Alinity — Abbott · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Proscia, Inc.
Sources (2)
- FDA UDI d9173c19-b795-490d-84c2-118e2322e050 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026