Smartdop XT6
Smartdop XT6 is a Class II device made by Koven Technology, Inc., cleared under FDA 510(k) K153762 on 25 May 2016 and listed in FDA GUDID since 22 Jun 2016 (UDI-DI 00894912002968), 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 | Number00894912002968 | Date22 Jun 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK153762 | Date25 May 2016 | StatusActive |
Official records
- AccessGUDID record 00894912002968
- FDA 510(k) database K153762
Across registries
- FDA 510(k) K153762 decided 25 May 2016 Active
- FDA GUDID UDI-DI 00894912002968 listed 22 Jun 2016 Listed
Timeline
- Cleared FDA 510(k) K153762
- Listed FDA GUDID 00894912002968
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- Withdrawn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 XT6
- Primary DI / UDI-DI
- 00894912002968
- 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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