Quantib Prostate 1.3
by Quantib B.V.
Quantib Prostate 1.3 is a Class II device made by Quantib B.V., listed in FDA GUDID since 13 Oct 2021 (UDI-DI 08719689791155), not in commercial distribution (GUDID) as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08719689791155 | Date13 Oct 2021 | StatusListed |
Official records
- AccessGUDID record 08719689791155
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Quantib Prostate
- Generic name
- Radiology DICOM image processing application software
- Model / reference
- 1.3
- Primary DI / UDI-DI
- 08719689791155
- FDA product code
- LLZ
- GMDN term
- Radiology DICOM image processing application software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- Not in Commercial Distribution
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