Uscan System P003965
by EchoNous
Uscan System P003965 is a Class II device made by EchoNous, cleared under FDA 510(k) K160420 on 21 Mar 2016 and listed in FDA GUDID since 21 Jul 2018 (UDI-DI 09353278000007), 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 | Number09353278000007 | Date21 Jul 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK160420 | Date21 Mar 2016 | StatusActive |
Official records
- AccessGUDID record 09353278000007
- FDA 510(k) database K160420
Across registries
- FDA 510(k) K160420 decided 21 Mar 2016 Active
- FDA GUDID UDI-DI 09353278000007 listed 21 Jul 2018 Listed
Timeline
- Cleared FDA 510(k) K160420
- Listed FDA GUDID 09353278000007
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Uscan System
- Generic name
- Hand-held ultrasound imaging system, body-surface
- Model / reference
- P003965
- Primary DI / UDI-DI
- 09353278000007
- 510(k) Number
- FDA product code
- IYO
- GMDN term
- Hand-held ultrasound imaging system, body-surface
- Device class
- Class II
- Regulation number
- 892.1560
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Hand-held ultrasound imaging system, body-surface.