Identity
- Trade Name
- Paige Prostate FDA UDI
- Generic Name
- Histology/cytology/microbiology image-analysis interpretive software IVD FDA UDI
- Device Name
- Paige Prostate is a software only device intended to assist pathologists in the detection of foci that are suspicious for cancer during the review of scanned whole slide images (WSI) from prostate needle biopsies prepared from hematoxylin & eosin (H&E) stained formalin-fixed paraffin embedded (FFPE) tissue. After initial diagnostic review of the WSI by the pathologist, if Paige Prostate detects tissue morphology suspicious for cancer, it provides coordinates (X,Y) on a single location on the image with the highest likelihood of having cancer for further review by the pathologist. FDA UDI
- Model / Reference
- 1.X FDA UDI
- Description
- Paige Prostate is a software only device intended to assist pathologists in the detection of foci that are suspicious for cancer during the review of scanned whole slide images (WSI) from prostate needle biopsies prepared from hematoxylin & eosin (H&E) stained formalin-fixed paraffin embedded (FFPE) tissue. After initial diagnostic review of the WSI by the pathologist, if Paige Prostate detects tissue morphology suspicious for cancer, it provides coordinates (X,Y) on a single location on the image with the highest likelihood of having cancer for further review by the pathologist. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860007599118 FDA UDI
- 510(k) Number
- DEN200080 FDA UDI
- FDA Product Code
- QPN FDA UDI
- GMDN Term
- Histology/cytology/microbiology image-analysis interpretive software IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.3750 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Histology/cytology/microbiology image-analysis interpretive software IVD
Paige Prostate by Paige.ai, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Histology/cytology/microbiology image-analysis interpretive software IVD.
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- VIRTUOSO System for IHC — Ventana Medical Systems · Class II
- Ibex Prostate Detect — IBEX MEDICAL ANALYTICS LTD · Class II
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
- Paige.ai, Inc
Sources (1)
- FDA UDI 50574731-36b3-45e1-bd64-5204f3bef0bc 34 fields · synced Jun 6, 2026