Uscan Linear Probe R005194
by EchoNous
Uscan Linear Probe R005194 is a Class II device made by EchoNous, cleared under FDA 510(k) K181574 on 10 Jul 2018 and listed in FDA GUDID since 29 Oct 2021 (UDI-DI 09353278000601), 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 | Number09353278000601 | Date29 Oct 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK181574 | Date10 Jul 2018 | StatusActive |
Official records
- AccessGUDID record 09353278000601
- FDA 510(k) database K181574
Across registries
- FDA 510(k) K181574 decided 10 Jul 2018 Active
- FDA GUDID UDI-DI 09353278000601 listed 29 Oct 2021 Listed
Timeline
- Cleared FDA 510(k) K181574
- Listed FDA GUDID 09353278000601
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Uscan Linear Probe
- Generic name
- Extracorporeal ultrasound imaging transducer, hand-held
- Model / reference
- R005194
- Primary DI / UDI-DI
- 09353278000601
- 510(k) Number
- FDA product code
- ITX
- GMDN term
- Extracorporeal ultrasound imaging transducer, hand-held
- Device class
- Class II
- Regulation number
- 892.1570
- GUDID distribution status
- In Commercial Distribution
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