Faxitron Path
A table intened to be used with only the Faxitron Path specimen radiography system as a stationary table with integrated mounting for the computer, keyboard, mouse and display.
2manufacturers in China registered for this device type
3catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Hologic, Inc., United States |
|---|---|
| FDA product code | MWP |
| Device type | Cabinet, X-Ray System |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1680 |
| Establishment | Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K122428 |
| Record published | 2021-08-17 |
| Record revised | 2024-04-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 0 to 75 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PATHVISION 23×29 | In distribution | |
| PATHVISION XL 43X43 | In distribution | |
| 2050-0104 | 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 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 |
| Faxitron CT | Hologic, Inc. | 1 |
Showing 12 of 25. All products under Cabinet, X-Ray System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K182727 | 2019-01-10 |
| K111508 | 2011-08-19 |
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.