Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Fiducial Marker

K-Number: K211590 · 2021-06-10

ApplicantCarbon Medical Technologies, Inc.
Decision Date2021-06-10
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Fiducial Marker is a medical device manufactured by Carbon Medical Technologies, Inc.. It received FDA 510(k) clearance on 2021-06-10 under approval number K211590. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fiducial Marker?

Fiducial Marker is a medical device that received FDA 510(k) clearance on 2021-06-10. It is manufactured by Carbon Medical Technologies, Inc.. The 510(k) number is K211590.

When was Fiducial Marker approved by the FDA?

Fiducial Marker received FDA 510(k) clearance on 2021-06-10, under approval number K211590.

What company makes Fiducial Marker?

Fiducial Marker is manufactured by Carbon Medical Technologies, Inc..

What is the FDA product code for Fiducial Marker?

The FDA product code for Fiducial Marker is IYE.

Related Clinical Trials

NCT05465161 STING MARK Universal Fiducial Marker System RECRUITING

Other Devices by Carbon Medical Technologies, Inc.

K172227Endoscopic Injection Needle K251748MammoSTAR Biopsy Site Identifier K253598InjecSURE Injection System PMA P980053AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE

Related Devices (Code: IYE)

K162476Varian High Energy Linear AcceleratorVarian Medical Systems, Inc. K161400ImagingRing SystemMedphoton GmbH K162468ClearCheckRadformation K162355Raycast MammoRx Carbon Fibre Breast BoardOrfit Industries NV K162577Dosimetry Check Version 5 Release 1Math Resolutions, LLC K162265CushionCast Moldable CushionsIzi Medical Products, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑