Quantib Prostate 2.0
by Quantib B.V.
Quantib Prostate 2.0 is a Class II device made by Quantib B.V., cleared under FDA 510(k) K221106 on 13 May 2022 and listed in FDA GUDID since 17 May 2022 (UDI-DI 08719689791186), 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 | Number08719689791186 | Date17 May 2022 | StatusListed |
| United States | FDA 510(k) | NumberK221106 | Date13 May 2022 | StatusActive |
Official records
- AccessGUDID record 08719689791186
- FDA 510(k) database K221106
Across registries
- FDA 510(k) K221106 decided 13 May 2022 Active
- FDA GUDID UDI-DI 08719689791186 listed 17 May 2022 Listed
Timeline
- Cleared FDA 510(k) K221106
- Listed FDA GUDID 08719689791186
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- Withdrawn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
- 2.0
- Primary DI / UDI-DI
- 08719689791186
- 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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