Smart Dx EVO2
by Bts SpA
Smart Dx EVO2 (SEVBUN02) is a Class II device made by Bts SpA, cleared under FDA 510(k) K131660 on 17 Apr 2014 and listed in FDA GUDID since 20 Dec 2024 (UDI-DI B179SEVBUN020), 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 | NumberB179SEVBUN020 | Date20 Dec 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK131660 | Date17 Apr 2014 | StatusActive |
Official records
- FDA 510(k) database K131660
Across registries
- FDA 510(k) K131660 decided 17 Apr 2014 Active
- FDA GUDID UDI-DI B179SEVBUN020 listed 20 Dec 2024 Listed
Timeline
- Cleared FDA 510(k) K131660
- Listed FDA GUDID B179SEVBUN020
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Smart
- Generic name
- Biomechanical function analysis system, motion-tracking
- Model / Ref / Catalog
- DX EVO2, SEVBUN02
- Primary DI / UDI-DI
- B179SEVBUN020
- 510(k) Number
- FDA product code
- LXJ
- GMDN term
- Biomechanical function analysis system, motion-tracking
- Device class
- Class II
- Regulation number
- 890.5360
- GUDID distribution status
- In Commercial Distribution
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