CoreLite X-Ray Specimen Cabinet
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K193317 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 CoreLite X-Ray Specimen Cabinet is a dedicated specimen radiography system classified as a Cabinet, X-Ray System. It is designed for rapid verification of excised tissue specimens, particularly breast biopsy cores, to confirm the presence of microcalcifications or other relevant features during or near the biopsy procedure room. This device enables immediate imaging and assessment at the point of care, ensuring procedural accuracy.
The CoreLite X-Ray Specimen Cabinet is supplied as a standalone, compact unit intended for use in radiology settings, specifically within breast biopsy rooms. It is intended for single-use or reusable applications, though sterility and reuse instructions are not specified in the provided data. The device operates within standard MRI safety guidelines for non-MRI environments and is available in configurations corresponding to registration numbers 3010478247, 3017889703, 3005496266, 3006051164, 3026962577, and 3027847687. Storage and handling details are not detailed, but it has received FDA 510K clearance under the Radiology advisory committee.
Frequently asked questions
What is the CoreLite X-Ray Specimen Cabinet primarily used for in a clinical setting?
The CoreLite X-Ray Specimen Cabinet is designed specifically for rapid verification of excised tissue specimens, particularly breast biopsy cores. It allows immediate imaging and assessment at the point of care to confirm the presence of microcalcifications or other key features during or near the biopsy procedure, ensuring procedural accuracy.
How is the CoreLite X-Ray Specimen Cabinet supplied, and where is it intended for use?
The CoreLite X-Ray Specimen Cabinet is supplied as a standalone, compact unit and is intended for use in radiology settings, particularly within breast biopsy rooms. Its design ensures it can be integrated seamlessly into the workflow of these specialized areas.
Can the CoreLite X-Ray Specimen Cabinet be reused, and what are the implications for sterility?
The CoreLite X-Ray Specimen Cabinet is intended for either single-use or reusable applications, though the provided data does not specify sterility requirements or instructions for reuse. Clinicians should refer to the manufacturer’s guidelines for proper cleaning, disinfection, and reuse protocols to ensure patient safety and device integrity.
What regulatory pathway was followed for the CoreLite X-Ray Specimen Cabinet, and which advisory committee was involved?
The CoreLite X-Ray Specimen Cabinet received FDA clearance through a Traditional 510(k) pathway, determined to be Substantially Equivalent to a predicate device. The review was conducted under the Radiology (RA) Advisory Committee, ensuring compliance with radiology-specific regulations before clearance.
Are there different configurations or models available for the CoreLite X-Ray Specimen Cabinet, and how are they identified?
Yes, the CoreLite X-Ray Specimen Cabinet is available in multiple configurations, each corresponding to specific registration numbers: 3010478247, 3017889703, 3005496266, 3006051164, 3026962577, and 3027847687. These identifiers help distinguish between different setups or variants of the device.
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: CoreLite - Cirdan, Cirdan CoreLite™ Specimen Radiography System - BD, CoreLite: Specimen Radiography System for Breast Biopsy Cores - Cirdan, CoreLite X-Ray Cabinet Operator Manual | PDF - Scribd
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K193317 | Class II | Active |
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Manufacturer
- Manufacturer
- Cirdan Imaging Limited
Sources (1)
- FDA 510(k) K193317 24 fields · synced Sep 20, 2026