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C4 IMAGING LLC

Matched from indexed company URL: C4 Imaging LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30108138193010813819C4 IMAGING LLC1N2026-01-016575 West Loop South, Suite 500 Bellaire TX US 77401

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00863593000204Sirius MRI Marker - The SIRIUS MRI Marker is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sleeves and radionuclide brachytherapy sources containing one of the following isotopes: Iodine 125 (125I), Palladium 103 (103Pd) or Cesium 131 (131Cs). It is indicated for permanent interstitial implantation in the prostate of patients with confirmed prostatic malignancy.713-280-1843abright@c4imaging.com
00863593000211Sirius MRI Marker - The SIRIUS MRI Marker is a component device indicated as an accessory for use in conjunction with brachytherapy seed carriersleeves and radionuclide brachytherapy sources containing one of the following isotopes: Iodine 125 (125I), Palladium 103(103Pd) or Cesium 131 (131Cs). It is indicated for permanent interstitial implantation in the prostate of patients with confirmedprostatic malignancy.713-280-1843abright@c4imaging.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1699732014076110K192771C4 Fiducial MarkerNEU2020-10-21
1699731881117618K180069HDR MRI Lumen MarkerJAQ2018-04-27
1699731422462446K171487Sirius MRI Marker NSKXK2017-08-25
1699731285940439K131689MRI MARKERKXK2013-11-20

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KXK22017-08-25
NEU12020-10-21
JAQ12018-04-27

PMN#

GUDID#

HDR MRI Lumen Marker - The HDR MRI Lumen Marker is a sealed high-density polyethylene (HDPE) tube containing a cobalt chloride N-Acetylcysteine saline solution. The HDPE tube is up to 350.0 mm in length and 1.0 mm in diameter, with the distal 19.0 mm of the tube accommodating a HDPE sealing plug. The distal end of the device is provided with an attached HDPE end-cap for handling. This end cap is approximately 3.0 mm in length. The HDR MRI Lumen Marker is an accessory to remote controlled high dose rate (HDR) radionuclide applicator systems and facilitates the identification of lumens within MRI compatible HDR brachytherapy applicators.

C4 IMAGING, LLC

2018-06-11