Quantib AI Node 2.4
by Quantib B.V.
Quantib AI Node 2.4 is a Class II device made by Quantib B.V., cleared under FDA 510(k) K200899 on 15 Jun 2020 and listed in FDA GUDID since 8 Nov 2021 (UDI-DI 08719689791162), 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 | Number08719689791162 | Date8 Nov 2021 | StatusListed |
| United States | FDA 510(k) | NumberK200899 | Date15 Jun 2020 | StatusActive |
Official records
- AccessGUDID record 08719689791162
- FDA 510(k) database K200899
Across registries
- FDA 510(k) K200899 decided 15 Jun 2020 Active
- FDA GUDID UDI-DI 08719689791162 listed 8 Nov 2021 Listed
Timeline
- Cleared FDA 510(k) K200899
- Listed FDA GUDID 08719689791162
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Quantib AI Node
- Generic name
- Radiology DICOM image processing application software
- Model / reference
- 2.4
- Primary DI / UDI-DI
- 08719689791162
- 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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