HDR MRI Lumen Marker— 510(k) K180069

Substantially Equivalent

C4 Imaging, LLC

FDA 510(k) clearance K180069 for HDR MRI Lumen Marker, Substantially Equivalent on 2018-04-27. Applicant: C4 Imaging, LLC. Device class: 2.

Clearance details

Applicant: C4 Imaging, LLC
Product code: Code JAQ
Device class: Class 2
Regulation: 21 CFR 892.5700
Advisory panel: Radiology
Date received: 2018-01-09
Decision date: 2018-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Doylestown, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JAQ

K262383 — LumenCare Azure2026-07-24
K252717 — MAASTRO Rectal Applicator Set2026-05-20
K251037 — Rectal Applicator2025-12-19
K252884 — Guided Aarhus Applicator Set2025-11-19
K250299 — CT/ MR Tandem and Ovoid Set2025-05-09

More clearances from C4 Imaging, LLC

K192771 — C4 Fiducial Marker2020-10-21
K171487 — Sirius MRI Marker NS2017-08-25
K131689 — MRI MARKER2013-11-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.