Biomarc Fiducial Marker
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- BiomarC Fiducial Marker EUDAMED
- Device Name
- BiomarC Carbon Fiducial Marker EUDAMED
- Model / Reference
- 040113 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10858015005858 EUDAMED
- Basic UDI-DI
- B-10858015005858 EUDAMED
- 510(k) Number
- K132708 FDA 510(k)
- FDA Product Code
- NEU 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 878.4300 FDA 510(k)
- Regulation Number
- 878.4300 FDA 510(k)
- Market of Registration
- Italy EUDAMED
- Advisory Committee
- General, Plastic Surgery 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 Fiducial Marker is a radiographic, implantable device designed to serve as a reference point for precise localization during imaging and radiation therapy procedures. Classified as a marker under FDA nomenclature, it aids in accurate targeting and alignment, ensuring optimal treatment delivery in clinical settings.
Supplied as a single-use, non-metallic implant, the Biomarc Fiducial Marker is intended for permanent placement within the body. Its pyrolytic carbon coating enhances biocompatibility and minimizes beam perturbation, particularly in proton therapy applications. Regulated under FDA 510(k) clearance and MDD compliance, it is distributed in sterile packaging for direct surgical implantation, adhering to Class II medical device standards.
Frequently asked questions
What is the Biomarc Fiducial Marker primarily used for in clinical settings?
The Biomarc Fiducial Marker is designed as a radiographic, implantable device to serve as a precise reference point during imaging and radiation therapy. Its purpose is to aid in accurate localization and alignment, ensuring optimal targeting and treatment delivery, particularly in procedures where precise placement is critical.
Is the Biomarc Fiducial Marker reusable or intended for single-use?
The Biomarc Fiducial Marker is explicitly supplied as a single-use device. It is intended for permanent implantation within the body, meaning it is not meant to be removed or reused after initial surgical placement.
What material is the Biomarc Fiducial Marker made of, and why is this important?
The Biomarc Fiducial Marker features a pyrolytic carbon coating, which enhances its biocompatibility and minimizes beam perturbation—especially important in proton therapy applications. This coating helps reduce interference with imaging and radiation beams, ensuring clearer and more accurate treatment outcomes.
How is the Biomarc Fiducial Marker packaged and prepared for surgical use?
The Biomarc Fiducial Marker is supplied in sterile packaging, ready for direct surgical implantation. This ensures it meets medical-grade sterility standards before use, reducing the risk of infection and ensuring safety during implantation.
What regulatory pathways has the Biomarc Fiducial Marker followed, and what does this mean for its use?
The Biomarc Fiducial Marker has undergone FDA 510(k) clearance and complies with the Medical Device Directive (MDD). This means it has been evaluated for safety and effectiveness by regulatory authorities and is classified as a Class II medical device, adhering to strict manufacturing and quality control standards.
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: Implantable Fiducial Markers - Carbon Medical Technologies, BiomarC - 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 | K132708 | Class II | Active |
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Manufacturer
- Manufacturer
- Carbon Medical Technologies, Inc.
Sources (2)
- FDA 510(k) K132708 24 fields · synced Oct 6, 2026
- EUDAMED 20b50134-62a9-4776-94b2-5848bea85bb5 61 fields · synced Jul 23, 2026