Trident HD Specimen Radiography
Trident HD is a cabinet X-ray system for imaging surgical and core-biopsy specimens. It helps verify that the intended tissue, lesion, calcification or site marker is present in the removed…
Trident HD is a cabinet X-ray system for imaging surgical and core-biopsy specimens. It helps verify that the intended tissue, lesion, calcification or site marker is present in the removed sample.
The self-contained digital system combines an imaging cabinet, image display and touchscreen controls. Shielding is built into the cabinet, and casters permit movement between nearby clinical work areas.
Listed Item
Cabinet x-ray device used to generate x-ray of specimens from various anatomical regions
Specimen Workflow
The system is intended for surgical or stereotactic biopsy suites and pathology laboratories. Users review the specimen’s digital radiograph to confirm excision during the biopsy workflow.
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) | K182727 |
| Record published | 2020-03-04 |
| Record revised | 2025-03-11 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature -10 to 40 °C; Handling environment temperature 15 to 30 °C; Storage environment atmospheric pressure 697 to 1060 millibar; Storage environment humidity 20 to 90 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TRI-00002 | In distribution | |
| TRI-00002 | 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 |
| 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.