C4 Fiducial Marker

FDA 510(k) K192771 · C4 Imaging, LLC

Substantially Equivalent

510(k) numberK192771

Submission

Device name
C4 Fiducial Marker
Applicant
C4 Imaging, LLC
Doylestown, PA, US
Received
September 30, 2019
Decision date
October 21, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NEU – Marker, Radiographic, Implantable
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4300
Specialty
General, Plastic Surgery
Implant
Yes

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Questions and answers

When was C4 Fiducial Marker cleared by the FDA?

C4 Fiducial Marker (K192771) received a 510(k) decision of Substantially Equivalent on October 21, 2020, 387 days after the submission was received.

What is the product code of K192771?

The FDA product code is NEU – Marker, Radiographic, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.