Trident HD Specimen Radiography System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K182727 FDA 510(k)
- FDA Product Code
- MWP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1680 FDA 510(k)
- Regulation Number
- 892.1680 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Trident HD Specimen Radiography System is a Cabinet X-Ray System designed for intraoperative imaging of breast biopsy specimens. It employs amorphous selenium direct capture imaging technology to produce high-resolution, clear radiographic images of excised tissue samples, aiding in the assessment of specimen integrity and completeness during surgical procedures.
This system is supplied as a reusable medical device and is intended for use in radiology settings. It operates under FDA 510(k) clearance (K182727) and EU MDR compliance, featuring automated exposure control (AEC) for consistent imaging performance. The device is classified as Class II under FDA regulations and includes multiple registration numbers (e.g., 3010478247) for tracking and regulatory purposes.
Frequently asked questions
What types of surgical settings or procedures is the Trident HD Specimen Radiography System primarily used for?
The Trident HD Specimen Radiography System is specifically designed for intraoperative imaging of breast biopsy specimens during surgical procedures. It helps clinicians assess the integrity and completeness of excised tissue samples directly in the operating room or radiology setting, ensuring accurate evaluation before further processing or pathology review.
How is the Trident HD Specimen Radiography System supplied, and is it reusable or single-use?
The Trident HD Specimen Radiography System is supplied as a reusable medical device, meaning it is intended for repeated use in radiology settings after proper cleaning, maintenance, and sterilization procedures. This design allows for consistent performance across multiple surgical cases.
What imaging technology does the Trident HD Specimen Radiography System use, and how does it benefit intraoperative assessment?
The system employs amorphous selenium direct capture imaging technology, which produces high-resolution, clear radiographic images of excised tissue samples. This technology ensures precise visualization of specimen integrity and completeness during surgery, reducing the risk of incomplete excision or specimen damage.
What regulatory pathways has the Trident HD Specimen Radiography System followed, and what does that mean for its use?
The device has undergone FDA 510(k) clearance (K182727) under the Traditional pathway, classified as Class II under FDA regulations. It also complies with EU MDR (Medical Device Regulation) standards. This means it meets established safety and performance criteria for use in radiology settings, ensuring reliability for intraoperative specimen imaging.
Are there multiple registration numbers associated with this device, and why might that be?
Yes, the Trident HD Specimen Radiography System includes multiple registration numbers (e.g., 3010478247, 3017889703, etc.) for tracking and regulatory compliance. These numbers correspond to different variants or configurations of the device, allowing for precise inventory management, reporting, and regulatory oversight by health authorities.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Trident® HD Specimen Radiography System | Hologic, PDF Trident HD Specimen Radiography System - Hologic, PDF Trident® HD Specimen Radiography System - hologic.se, PDF Trident® HD Specimen Radiography System - hologic.se
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K182727 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (2)
- FDA 510(k) K182727 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 19, 2026