Faxitron VisionCT 15x15
Faxitron VisionCT 15x15 is a stationary specimen x-ray system (FDA Class II; FDA product code MWP, Cabinet,X-Ray System) made by Faxitron Bioptics, LLC, cleared under FDA 510(k) K173309 on 9 May 2018 and listed in FDA GUDID since 4 Aug 2018 (UDI-DI 00857069006227), 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 | Number00857069006227 | Date4 Aug 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK173309 | Date9 May 2018 | StatusActive |
Official records
- AccessGUDID record 00857069006227
- FDA 510(k) database K173309
Across registries
- FDA 510(k) K173309 decided 9 May 2018 Active
- FDA GUDID UDI-DI 00857069006227 listed 4 Aug 2018 Listed
Timeline
- Cleared FDA 510(k) K173309
- Listed FDA GUDID 00857069006227
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Faxitron
- Generic name
- Stationary specimen x-ray system, digital
- Model / reference
- VisionCT 15x15
- Primary DI / UDI-DI
- 00857069006227
- 510(k) Number
- FDA product code
- MWP
- GMDN term
- Stationary specimen x-ray system, digital
- Device class
- Class II
- Regulation number
- 892.1680
- GUDID distribution status
- In Commercial Distribution
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Other devices filed under FDA product code MWP (Cabinet,X-Ray System).
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- 10 X 10 VISION by Bioptics, Inc.
- Kubec Xpert 80 Cabinet X-Ray System by KUB TECHNOLOGIES INC
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- Mozart Supra (XPERT 84) Radiography System by KUB TECHNOLOGIES INC
- CoreLite X-Ray Specimen Cabinet by Cirdan Imaging Limited
- Faxitron Specimen Radiography System Model MX-20 by Faxitron X-Ray Corp.