Faxitron Path
Faxitron PathVision is a cabinet X-ray system for imaging surgically removed tissue specimens. It helps verify the tissue removed during a biopsy by providing film or digital radiographs of…
Faxitron PathVision is a cabinet X-ray system for imaging surgically removed tissue specimens. It helps verify the tissue removed during a biopsy by providing film or digital radiographs of the excised specimen. The listed configuration has a 23 by 29 cm digital imaging area.
The specimen is imaged inside a shielded cabinet. A small X-ray focal spot and the cabinet geometry allow geometric magnification up to six times. An integrated camera and acquisition software generate the digital images.
Image Workflow
The digital system supports DICOM storage, printing, and modality worklists. It includes a network-ready workstation and monitor for viewing and handling specimen images. Imaging is performed on removed specimens.
Who Else Makes It
All of them in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Compai Healthcare (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Compai Medtech (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Faxitron Bioptics, LLC, United States |
|---|---|
| FDA product code | MWP |
| Device type | Cabinet, X-Ray System |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1680 |
| 510(k) | K122428 |
| Record published | 2019-07-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PathVision 23×29 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Timberline MPF Lateral Modular Plate Fixation System | Biomet Spine | 11 |
| Faxitron | Faxitron Bioptics, LLC | 11 |
| Timberline® MPF Lateral Interbody Modular Plate Fixation System | Biomet Spine | 10 |
| Kubtec | Kubtec | 4 |
| Faxitron Path | Hologic, Inc. | 3 |
| Faxitron Core | Hologic, Inc. | 2 |
| TrueView | Compai Healthcare (Suzhou) Co., Ltd. | 2 |
| TrueView | Compai Medtech (Suzhou) Co., Ltd. | 2 |
| Trident HD Specimen Radiography | Hologic, Inc. | 2 |
| Faxitron Core | Faxitron Bioptics, LLC | 1 |
| XPERT84 | Kubtec | 1 |
| Faxitron Wedge | Hologic, Inc. | 1 |
Showing 12 of 25. All products under Cabinet, X-Ray System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K183142 | 2019-03-14 |
| K173309 | 2018-05-09 |
| K170786 | 2017-07-18 |
| K153583 | 2016-04-01 |
| K122428 | 2012-09-25 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.