C4 Fiducial Marker

Marker, Radiographic, Implantable

C4 Imaging LLC

The following data is part of a premarket notification filed by C4 Imaging Llc with the FDA for C4 Fiducial Marker.

Pre-market Notification Details

Device IDK192771
510k NumberK192771
Device Name:C4 Fiducial Marker
ClassificationMarker, Radiographic, Implantable
Applicant C4 Imaging LLC 196 West Ashland Street Doylestown,  PA  18901
ContactAndrew Bright
CorrespondentAndrew Bright
C4 Imaging LLC 196 West Ashland Street Doylestown,  PA  18901
Product CodeNEU  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-30
Decision Date2020-10-21

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