Faxitron PathVision 23x29 cm
Faxitron PathVision 23x29 cm 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) K122428 on 25 Sep 2012 and listed in FDA GUDID since 17 Aug 2016 (UDI-DI 00857069006050), 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 | Number00857069006050 | Date17 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK122428 | Date25 Sep 2012 | StatusActive |
Official records
- AccessGUDID record 00857069006050
- FDA 510(k) database K122428
Across registries
- FDA 510(k) K122428 decided 25 Sep 2012 Active
- FDA GUDID UDI-DI 00857069006050 listed 17 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K122428
- Listed FDA GUDID 00857069006050
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- Withdrawn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
- PathVision 23x29 cm
- Primary DI / UDI-DI
- 00857069006050
- 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
Similar devices
Other devices filed under FDA product code MWP (Cabinet,X-Ray System).
- Xpert 40 Specimen 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.
- TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) by CompAI Healthcare (Suzhou) Co., ltd
- TrueView 200 Pro-US Specimen Radiography System by CompAI Healthcare (Suzhou) Co., ltd
- TrueView 100 Pro by Compai Healthcare (Shenzhen) Co., Ltd
- BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM by Bioptics, Inc.
- MICRO-FOCUS 50 CABINET X-RAY by Micro-Focus Imaging., Inc.
- Kubtec Mozart XPERT42 by KUB TECHNOLOGIES INC
- CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM by Bioptics, Inc.