FDA 510(k)

C4 Fiducial Marker

K-Number: K192771 · 2020-10-21

Decision Date2020-10-21

Product CodeNEU

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

C4 Fiducial Marker is a medical device manufactured by C4 Imaging, LLC. It received FDA 510(k) clearance on 2020-10-21 under approval number K192771. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C4 Fiducial Marker?

C4 Fiducial Marker is a medical device that received FDA 510(k) clearance on 2020-10-21. It is manufactured by C4 Imaging, LLC. The 510(k) number is K192771.

When was C4 Fiducial Marker approved by the FDA?

C4 Fiducial Marker received FDA 510(k) clearance on 2020-10-21, under approval number K192771.

What company makes C4 Fiducial Marker?

C4 Fiducial Marker is manufactured by C4 Imaging, LLC.

What is the FDA product code for C4 Fiducial Marker?

The FDA product code for C4 Fiducial Marker is NEU.

Related Clinical Trials

NCT05465161 STING MARK Universal Fiducial Marker System RECRUITING

Other Devices by C4 Imaging, LLC

K171487Sirius MRI Marker NS K180069HDR MRI Lumen Marker

Related Devices (Code: NEU)

K152510UltraCor Twirl Breast Tissue MarkerBard Peripheral Vascular, Inc. K161021HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc. K171767Cianna Medical SAVI Scout Reflector and SAVI Scout SystemCianna Medical, Inc. K170803HydroMARK Breast Biopsy Site MarkersDevicor Medical Products, Inc. K170026Radiopaque Tissue MarkerViscus Biologics, LLC K170905Star Tissue MarkerScion Medical Technologies, 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.