Faxitron Bioptics Speciemen Radiography System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K170786 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 Faxitron Bioptics Specimen Radiography System is a Cabinet, X-Ray System designed for radiography of biological specimens. It produces high-resolution images of tissue samples, including breast tissue slices, intact mastectomy specimens, bone, and fetal remains, enabling detailed examination for diagnostic purposes in radiology settings.
This system is intended for use in radiology departments and surgical pathology laboratories. It is supplied as a reusable medical device and requires appropriate training for operation. The system is classified as Class II under FDA regulations and has been granted FDA 510(k) clearance through a Traditional review process. Multiple registration numbers (e.g., 3010478247) and FEI numbers (e.g., 3017889703) are associated with its regulatory compliance.
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: FaxitronPath® Digital Pathology System | Hologic, Faxitron Core Specimen Radiography Inserts/IFUs | Hologic, PDF Specimen Radiography System - hologic.ca, Faxitron® Path System | Specimen Radiography | Hologic® UK, Faxitron Bioptics Speciemen Radiography - allmed.wiki
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170786 | Class II | Active |
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Manufacturer
- Manufacturer
- Faxitron Bioptics, LLC
Sources (1)
- FDA 510(k) K170786 24 fields · synced Sep 20, 2026