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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#