BiomarC Gold Fiducial Marker
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- BiomarC Gold Fiducial Marker EUDAMED
- Device Name
- BiomarC Gold Fiducial Marker EUDAMED
- Model / Reference
- 040118 EUDAMED040129 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10858015005896 EUDAMED10850002461012 EUDAMED
- Basic UDI-DI
- B-10858015005896 EUDAMEDB-10850002461012 EUDAMED
- 510(k) Number
- K130678 FDA 510(k)
- FDA Product Code
- IYE FDA 510(k)
- EMDN Code
- A019012 BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)
- Market of Registration
- Italy EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The BiomarC Gold Fiducial Marker is a fiducial marker (IYE product code) designed for use in radiation therapy. These markers are implantable devices made of pure gold, intended to enhance imaging accuracy during procedures such as X-ray, CT, CBCT, and both kV and MV imaging modalities. Their primary function is to serve as precise reference points for treatment planning and delivery.
The markers are supplied in sterile, individually pouched packaging and are available in varying sizes, including 0.9×3mm and 1.2×3mm, paired with needles of 18g (20cm) or 17g (20cm or 30cm). They are knurled to minimize migration and are manufactured with a pyrolytic carbon coating for biocompatibility. The device holds FDA 510K clearance and MDD authorization, adhering to regulatory standards for implantable medical devices. Storage and handling follow sterile medical device protocols.
Frequently asked questions
What imaging modalities are the BiomarC Gold Fiducial Markers designed to enhance during radiation therapy?
The BiomarC Gold Fiducial Markers are specifically designed to improve imaging accuracy for X-ray, CT, CBCT, and both kV (kilovoltage) and MV (megavoltage) imaging modalities. Their gold composition ensures clear visibility across these imaging techniques, making them reliable reference points for precise treatment planning and delivery.
Are the BiomarC Gold Fiducial Markers single-use or reusable, and how should they be stored?
The BiomarC Gold Fiducial Markers are intended for single-use only. They are supplied in sterile, individually pouched packaging, which must be maintained under sterile conditions. Storage should follow standard sterile medical device protocols to preserve integrity until use.
What needle sizes and marker dimensions are available for the BiomarC Gold Fiducial Markers?
The BiomarC Gold Fiducial Markers come in two sizes: 0.9×3mm and 1.2×3mm. They are paired with either an 18-gauge needle (20cm length) or a 17-gauge needle (available in 20cm or 30cm lengths), allowing flexibility depending on clinical requirements.
Why are the BiomarC Gold Fiducial Markers coated with pyrolytic carbon?
The pyrolytic carbon coating on the BiomarC Gold Fiducial Markers enhances biocompatibility, reducing the risk of adverse reactions when implanted. This coating also helps maintain the marker’s stability and minimizes migration within the tissue.
What regulatory pathways have the BiomarC Gold Fiducial Markers undergone, and what does this mean for clinical use?
The BiomarC Gold Fiducial Markers hold FDA 510(k) clearance and MDD authorization, confirming they meet regulatory standards for implantable medical devices. This clearance indicates the device has been deemed substantially equivalent to a legally marketed predicate device, ensuring compliance with safety and performance requirements for clinical use in radiation therapy.
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: BiomarC Gold - Carbon Medical Technologies, Implantable Fiducial Markers - Carbon Medical Technologies, Carbon Medical Technologies' BiomarC Fiducial Markers and BiomarC ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K130678 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Carbon Medical Technologies, Inc.
Sources (3)
- FDA 510(k) K130678 24 fields · synced Oct 6, 2026
- EUDAMED ea2866b7-f2ab-45a1-85c5-ea99f8ce40c8 61 fields · synced Jul 12, 2026
- EUDAMED 2cf0fa3e-acdc-43db-aa17-0746869853c9 61 fields · synced Jul 18, 2026