Faxitron BioVision +
Faxitron BioVision + is a tissue specimen x-ray system IVD (FDA Class II; FDA product code MWP, Cabinet,X-Ray System) made by Faxitron Bioptics, LLC, cleared under FDA 510(k) K153583 on 1 Apr 2016 and listed in FDA GUDID since 5 Jun 2018 (UDI-DI 00857069006210), 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 | Number00857069006210 | Date5 Jun 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK153583 | Date1 Apr 2016 | StatusActive |
Official records
- AccessGUDID record 00857069006210
- FDA 510(k) database K153583
Across registries
- FDA 510(k) K153583 decided 1 Apr 2016 Active
- FDA GUDID UDI-DI 00857069006210 listed 5 Jun 2018 Listed
Timeline
- Cleared FDA 510(k) K153583
- Listed FDA GUDID 00857069006210
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Faxitron
- Generic name
- Tissue specimen x-ray system IVD
- Model / reference
- BioVision +
- Primary DI / UDI-DI
- 00857069006210
- 510(k) Number
- FDA product code
- MWP
- GMDN term
- Tissue specimen x-ray system IVD
- Device class
- Class II
- Regulation number
- 892.1680
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
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