Faxitron
Stationary digital specimen x-ray system with 12x15 cm imager intended for the verification of harvested biopsy specimens. The VersaVision x-ray cabinet is designed as a digital system, but…
Stationary digital specimen x-ray system with 12×15 cm imager intended for the verification of harvested biopsy specimens. The VersaVision x-ray cabinet is designed as a digital system, but can also be used with film.
2manufacturers in China registered for this device type
11catalogue numbers in this listing
5510(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 | 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) | K173309 |
| Record published | 2018-08-04 |
| Record revised | 2022-06-10 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VisionCT 15×15 | In distribution | |
| VersaVision 12×15 | In distribution | |
| BioVision 10×12.5 | In distribution | |
| VersaVision 10×15 | In distribution | |
| VersaVision 6×15 | In distribution | |
| CoreVision 5×10 | In distribution | |
| BioVision + | In distribution | |
| BioVision 10×10 | In distribution | |
| PathVision 23×29 cm | In distribution | |
| BioVision Plus 12×15 | In distribution | |
| BioVision 10×15 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Timberline MPF Lateral Modular Plate Fixation System | Biomet Spine | 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 |
| Faxitron CT | 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.