Vicon Bonita System
Vicon Bonita System is a Class II device made by Vicon Motion Systems Inc, cleared under FDA 510(k) K811172 on 16 Jun 1981 and listed in FDA GUDID since 18 Apr 2017 (UDI-DI B548BONITASYSTEM0), 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 | NumberB548BONITASYSTEM0 | Date18 Apr 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK811172 | Date16 Jun 1981 | StatusActive |
Official records
- FDA 510(k) database K811172
Across registries
- FDA 510(k) K811172 decided 16 Jun 1981 Active
- FDA GUDID UDI-DI B548BONITASYSTEM0 listed 18 Apr 2017 Listed
Timeline
- Cleared FDA 510(k) K811172
- Listed FDA GUDID B548BONITASYSTEM0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Vicon
- Generic name
- Gait analysis system
- Model / reference
- BONITA SYSTEM
- Primary DI / UDI-DI
- B548BONITASYSTEM0
- 510(k) Number
- FDA product code
- LXJ
- GMDN term
- Gait analysis system
- Device class
- Class II
- Regulation number
- 890.5360
- GUDID distribution status
- In Commercial Distribution
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