BioVision Plus
510(k) K153583
BioVision Plus is a medical device (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, 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 | FDA 510(k)SESE | NumberK153583 | Date1 Apr 2016 | StatusActive |
Official records
- FDA 510(k) database K153583
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MWP
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1680
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K153583
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Faxitron BioVision + | BioVision + | 00857069006210 | — | On the market |
| Faxitron BioVision Plus 12x15 | BioVision Plus 12x15 | 00857069006043 | — | On the market |
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Other devices filed under FDA product code MWP (Cabinet, X-Ray System).
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