Aviso (S)
Aviso (S) is a Class II device made by Quantel Medical, cleared under FDA 510(k) K051851 on 3 Aug 2005 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 03700542625002), active as of 21 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 | Number03700542625002 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK051851 | Date3 Aug 2005 | StatusActive |
Official records
- AccessGUDID record 03700542625002
- FDA 510(k) database K051851
Across registries
- FDA 510(k) K051851 decided 3 Aug 2005 Active
- FDA GUDID UDI-DI 03700542625002 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K051851
- Listed FDA GUDID 03700542625002
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Ophthalmic ultrasound imaging system
- Model / reference
- AVISO (S)
- Primary DI / UDI-DI
- 03700542625002
- 510(k) Number
- FDA product code
- ITX, IYO
- GMDN term
- Ophthalmic ultrasound imaging system
- Device class
- Class II
- Regulation number
- 892.1570, 892.1560
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Ophthalmic ultrasound imaging system.