Smartdop XT
Smartdop XT is a Class II device made by Koven Technology, Inc., cleared under FDA 510(k) K131623 on 17 Jan 2014 and listed in FDA GUDID since 25 Feb 2016 (UDI-DI 00894912002852), 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 | Number00894912002852 | Date25 Feb 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK131623 | Date17 Jan 2014 | StatusActive |
Official records
- AccessGUDID record 00894912002852
- FDA 510(k) database K131623
Across registries
- FDA 510(k) K131623 decided 17 Jan 2014 Active
- FDA GUDID UDI-DI 00894912002852 listed 25 Feb 2016 Listed
Timeline
- Cleared FDA 510(k) K131623
- Listed FDA GUDID 00894912002852
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Noninvasive vascular ultrasound system, line-powered
- Model / Ref / Catalog
- Smartdop XT
- Primary DI / UDI-DI
- 00894912002852
- 510(k) Number
- FDA product code
- JOP
- GMDN term
- Noninvasive vascular ultrasound system, line-powered
- Device class
- Class II
- Regulation number
- 870.2880
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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