Gui Sda-001
Gui Sda-001 is a Class II device made by Sonivate Medical, Inc., cleared under FDA 510(k) K192253 on 25 Feb 2020 and listed in FDA GUDID since 10 Jun 2020 (UDI-DI 00850012978015), 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 | Number00850012978015 | Date10 Jun 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK192253 | Date25 Feb 2020 | StatusActive |
Official records
- AccessGUDID record 00850012978015
- FDA 510(k) database K192253
Across registries
- FDA 510(k) K192253 decided 25 Feb 2020 Active
- FDA GUDID UDI-DI 00850012978015 listed 10 Jun 2020 Listed
Timeline
- Cleared FDA 510(k) K192253
- Listed FDA GUDID 00850012978015
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Gui
- Generic name
- Hand-held ultrasound imaging system, body-surface
- Model / reference
- SDA-001
- Primary DI / UDI-DI
- 00850012978015
- 510(k) Number
- FDA product code
- IYO, ITX
- GMDN term
- Hand-held ultrasound imaging system, body-surface
- Device class
- Class II
- Regulation number
- 892.1560, 892.1570
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Hand-held ultrasound imaging system, body-surface.