Quantib Prostate 1.0
by Quantib B.V.
Quantib Prostate 1.0 is a Class II device made by Quantib B.V., cleared under FDA 510(k) K202501 on 11 Oct 2020 and listed in FDA GUDID since 30 Oct 2020 (UDI-DI 08719689791056), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08719689791056 | Date30 Oct 2020 | StatusListed |
| United States | FDA 510(k) | NumberK202501 | Date11 Oct 2020 | StatusActive |
Official records
- AccessGUDID record 08719689791056
- FDA 510(k) database K202501
Across registries
- FDA 510(k) K202501 decided 11 Oct 2020 Active
- FDA GUDID UDI-DI 08719689791056 listed 30 Oct 2020 Listed
Timeline
- Cleared FDA 510(k) K202501
- Listed FDA GUDID 08719689791056
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Quantib Prostate
- Generic name
- Radiology DICOM image processing application software
- Model / reference
- 1.0
- Primary DI / UDI-DI
- 08719689791056
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Radiology DICOM image processing application software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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