SonoScape 6V4
SonoScape 6V4 is a rectal/vaginal ultrasound imaging transducer (FDA Class II) made by Sonoscape Medical Corp., cleared under FDA 510(k) K123616 on 21 Dec 2012 and listed in FDA GUDID since 19 Aug 2016 (UDI-DI 06945868600600), 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 | Number06945868600600 | Date19 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK123616 | Date21 Dec 2012 | StatusActive |
Official records
- AccessGUDID record 06945868600600
- FDA 510(k) database K123616
Across registries
- FDA 510(k) K123616 decided 21 Dec 2012 Active
- FDA GUDID UDI-DI 06945868600600 listed 19 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K123616
- Listed FDA GUDID 06945868600600
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SonoScape
- Generic name
- Rectal/vaginal ultrasound imaging transducer
- Model / reference
- 6V4
- Primary DI / UDI-DI
- 06945868600600
- 510(k) Number
- FDA product code
- ITX, IYO, IYN
- GMDN term
- Rectal/vaginal ultrasound imaging transducer
- Device class
- Class II
- Regulation number
- 892.1570, 892.1560, 892.1550
- GUDID distribution status
- In Commercial Distribution
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