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FDA 510(k)

BiomarC Fiducial Marker

K-Number: K191797 · 2019-07-29

ApplicantCarbon Medical Technologies
Decision Date2019-07-29
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BiomarC Fiducial Marker is the device name listed in this FDA 510(k) record. The listed applicant is Carbon Medical Technologies. It received FDA 510(k) clearance on 2019-07-29 under 510(k) number K191797. 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 BiomarC Fiducial Marker?

BiomarC Fiducial Marker is a medical device that received FDA 510(k) clearance on 2019-07-29. The listed applicant is Carbon Medical Technologies. The 510(k) number is K191797.

When did BiomarC Fiducial Marker receive FDA 510(k) clearance?

BiomarC Fiducial Marker received FDA 510(k) clearance on 2019-07-29, under 510(k) number K191797.

Who is the listed applicant for BiomarC Fiducial Marker?

The FDA 510(k) record lists Carbon Medical Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BiomarC Fiducial Marker?

The FDA product code for BiomarC Fiducial Marker is IYE.

Other records listing Carbon Medical Technologies as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253598InjecSURE Injection SystemPMA P980053AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USEK251748MammoSTAR Biopsy Site IdentifierK211590Fiducial MarkerK172227Endoscopic Injection Needle

Related Devices (Code: IYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser ApplikationenK260792AerFrame Patient Immobilization System (AFPIS)Stabilix, LLCK252258VERIQA RT EPID 3DPtw-Freiburg Physikalisch-Technische-Werkstaetten Dr. PychlaK253962ClearCheck (RADCC V2.7)Radformation, Inc.

Official Source

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

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