Identity
- Trade Name
- QP-Prostate® CAD FDA UDI
- Generic Name
- MRI image interpretive software FDA UDI
- Device Name
- QP-Prostate® CAD is an artificial intelligence-based Computed Aided Detection and Diagnosis (CADe/CADx) image processing software. QP-Prostate® CAD uses AI-based algorithms trained with pathology data to detect suspicious lesions for clinically significant prostate cancer. The device automatically detects and identifies suspected lesions in the prostate gland based on bi-parametric prostate MRI and provides marks over regions of the images that may contain suspected lesions. There are two possible markers that are provided in the different colors suggesting different levels of suspicion of clinically significant prostate cancer (moderate or high suspicion level). FDA UDI
- Model / Reference
- 1.1 FDA UDI
- Description
- QP-Prostate® CAD is an artificial intelligence-based Computed Aided Detection and Diagnosis (CADe/CADx) image processing software. QP-Prostate® CAD uses AI-based algorithms trained with pathology data to detect suspicious lesions for clinically significant prostate cancer. The device automatically detects and identifies suspected lesions in the prostate gland based on bi-parametric prostate MRI and provides marks over regions of the images that may contain suspected lesions. There are two possible markers that are provided in the different colors suggesting different levels of suspicion of clinically significant prostate cancer (moderate or high suspicion level). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08437021468168 FDA UDI
- 510(k) Number
- K242683 FDA UDI
- FDA Product Code
- QDQ FDA UDI
- GMDN Term
- MRI image interpretive software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2090 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
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: MRI image interpretive software
QP-Prostate® CAD by Quibim Sociedad Limitada. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as MRI image interpretive software.
- Unfold AI — Avenda Health, Inc. · Class II
- Mycardium — Mycardium AI Limited · Class II
- Unfold AI — Avenda Health, Inc. · Class II
- Unfold AI — Avenda Health, Inc. · Class II
- Unfold AI — Avenda Health, Inc. · Class II
- Unfold AI — Avenda Health, Inc. · Class II
- Unfold AI — Avenda Health, Inc. · Class II
- Unfold AI — Avenda Health, Inc. · Class II
Cleared under the same submission
K242683 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Quibim Sociedad Limitada.
Sources (1)
- FDA UDI bb147bc5-dbc9-4ca1-909f-a4782e5116f1 35 fields · synced May 30, 2026