FDA 510(k)

HDR MRI Lumen Marker

K-Number: K180069 · 2018-04-27

Decision Date2018-04-27

Product CodeJAQ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

HDR MRI Lumen Marker is the device name listed in this FDA 510(k) record. The listed applicant is C4 Imaging, LLC. It received FDA 510(k) clearance on 2018-04-27 under 510(k) number K180069. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HDR MRI Lumen Marker?

HDR MRI Lumen Marker is a medical device that received FDA 510(k) clearance on 2018-04-27. The listed applicant is C4 Imaging, LLC. The 510(k) number is K180069.

When did HDR MRI Lumen Marker receive FDA 510(k) clearance?

HDR MRI Lumen Marker received FDA 510(k) clearance on 2018-04-27, under 510(k) number K180069.

Who is the listed applicant for HDR MRI Lumen Marker?

The FDA 510(k) record lists C4 Imaging, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HDR MRI Lumen Marker?

The FDA product code for HDR MRI Lumen Marker is JAQ.

Other records listing C4 Imaging, LLC 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.

K192771C4 Fiducial Marker K171487Sirius MRI Marker NS

Related Devices (Code: JAQ)

K262383LumenCare AzureNucletron B.V.K252717MAASTRO Rectal Applicator SetVarian Medical Systems K251037Rectal ApplicatorNucletron B.V.K252884Guided Aarhus Applicator SetVarian Medical Systems K250299CT/ MR Tandem and Ovoid SetVarian Medical Systems, Inc.K250289Intracavitary/Interstitial SystemVarian Medical Systems

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.