SonoScape EC9-5
SonoScape EC9-5 is a Class II device made by Sonoscape Medical Corp., cleared under FDA 510(k) K112451 on 16 Sep 2011 and listed in FDA GUDID since 19 Aug 2016 (UDI-DI 06945868600211), active as of 22 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 | Number06945868600211 | Date19 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK112451 | Date16 Sep 2011 | StatusActive |
Official records
- AccessGUDID record 06945868600211
- FDA 510(k) database K112451
Across registries
- FDA 510(k) K112451 decided 16 Sep 2011 Active
- FDA GUDID UDI-DI 06945868600211 listed 19 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K112451
- Listed FDA GUDID 06945868600211
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SonoScape
- Generic name
- Rectal ultrasound imaging system transducer
- Model / reference
- EC9-5
- Primary DI / UDI-DI
- 06945868600211
- 510(k) Number
- FDA product code
- ITX, IYO, IYN
- GMDN term
- Rectal ultrasound imaging system transducer
- Device class
- Class II
- Regulation number
- 892.1570, 892.1560, 892.1550
- GUDID distribution status
- In Commercial Distribution
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