Identifiers
- 510(k) Number
- K211590 FDA 510(k)
- FDA Product Code
- IYE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
A fiducial marker is an object placed in the field of view of an image for use as a point of reference or a measure. The BiomarC Fiducial Marker is a sterile, pyrogen-free, single patient use device that is visible on standard radiographs and Magnetic Resonance Imaging (MRI).
The marker is available in pyrolytic carbon coated or gold versions and is supplied as a sterile, single patient use device. It is manufactured by Carbon Medical Technologies, Inc. and has FDA 510K clearance with product code IYE.
Frequently asked questions
What is the BiomarC Fiducial Marker used for?
The BiomarC Fiducial Marker is an object placed in the field of view of an image for use as a point of reference or a measure. It is designed to be visible on standard radiographs and Magnetic Resonance Imaging (MRI).
How is the BiomarC Fiducial Marker supplied and what are its sterility characteristics?
The BiomarC Fiducial Marker is supplied as a sterile, pyrogen-free, single patient use device. It is available in pyrolytic carbon coated or gold versions, ensuring compatibility with various imaging modalities while maintaining sterility for each patient.
What is the regulatory status of the BiomarC Fiducial Marker?
The BiomarC Fiducial Marker has FDA 510K clearance with product code IYE. It was manufactured by Carbon Medical Technologies, Inc. and received clearance on June 10, 2021, with a decision code of SESE (Substantially Equivalent).
Can the BiomarC Fiducial Marker be reused or is it single-use only?
The BiomarC Fiducial Marker is designed for single patient use only. It is supplied as a sterile device and should not be reused to ensure patient safety and maintain the integrity of the imaging reference point.
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: Fiducial marker - Wikipedia, Implantable Fiducial Markers - Carbon Medical Technologies, PDF Carbon Medical Technologies, Inc. BiomarC Fiducial Marker
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211590 | Class II | Active |
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Manufacturer
- Manufacturer
- Carbon Medical Technologies, Inc.
Sources (1)
- FDA 510(k) K211590 24 fields · synced Oct 6, 2026