Identity
- Trade Name
- QP-Prostate FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- Software for quantitative analysis of prostate MRI QP-Prostate® is an image processing software package to be used by trained professionals, including radiologists specialized in prostate imaging, urologists and oncologists. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing and analysis of prostate MR images. Data and images are acquired through DICOM compliant imaging devices and modalities. Patient management decisions should not be based solely on the results of QP-Prostate®. QP-Prostate® does not perform a diagnostic function, but instead allows the users to visualize and analyze DICOM data. FDA UDI
- Model / Reference
- 1.5 FDA UDI
- Description
- Software for quantitative analysis of prostate MRI QP-Prostate® is an image processing software package to be used by trained professionals, including radiologists specialized in prostate imaging, urologists and oncologists. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing and analysis of prostate MR images. Data and images are acquired through DICOM compliant imaging devices and modalities. Patient management decisions should not be based solely on the results of QP-Prostate®. QP-Prostate® does not perform a diagnostic function, but instead allows the users to visualize and analyze DICOM data. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08437021468144 FDA UDI
- 510(k) Number
- K203582 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 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: Radiology DICOM image processing application software
QP-Prostate by Quibim Sociedad Limitada. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K203582 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 |
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Manufacturer
- Manufacturer
- Quibim Sociedad Limitada.
Sources (1)
- FDA UDI f9400dda-591b-4d65-b62a-c6976151faec 35 fields · synced Jun 8, 2026