C4 Fiducial Marker
C4 Imaging LLC
C4 IMAGING LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010813819 | 3010813819 | C4 IMAGING LLC | 1 | N | 2026-01-01 | 6575 West Loop South, Suite 500 Bellaire TX US 77401 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 169973 | 2014076110 | K192771 | C4 Fiducial Marker | NEU | 2020-10-21 |
| 169973 | 1881117618 | K180069 | HDR MRI Lumen Marker | JAQ | 2018-04-27 |
| 169973 | 1422462446 | K171487 | Sirius MRI Marker NS | KXK | 2017-08-25 |
| 169973 | 1285940439 | K131689 | MRI MARKER | KXK | 2013-11-20 |
Product Codes Associated With Registrations#
PMN#
HDR MRI Lumen Marker
C4 Imaging LLC
Sirius MRI Marker NS
C4 Imaging, LLC
MRI MARKER
C4 IMAGING LLC
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.
2018-06-11
Nova 5 - The Fiducial Marker consists of a sealed polyether ether ketone (PEEK) polymer capsule containing a solution of up to 1.0% cobalt chloride and up to 2.0% N-Acetyl cysteine, in a ratio of 1:2. Zirconium oxide is sealed within the device. The length of the polymer capsule is between 5.5 mm and 10.0 mm, and the diameter is 1.0 mm. It is loaded in an implant needle and sterilized with Ethylene Oxide.
2021-09-03
Nova 5 - The Fiducial Marker consists of a sealed polyether ether ketone (PEEK) polymer capsule containing a solution of up to 1.0% cobalt chloride and up to 2.0% N-Acetyl cysteine, in a ratio of 1:2. Zirconium oxide is sealed within the device. The length of the polymer capsule is between 5.5 mm and 10.0 mm, and the diameter is between 0.9 mm and 1.2 mm.
2021-09-03
Nova 10 Fiducial Marker - F-01-03-0115
2022-04-25
Nova Z - Carton Containing up to 10 Fiducial Marker Loaded Needle Assemblies
2025-10-06
Nova Z - Fiducial marker loaded needle assembly
2025-10-06
Nova Z - Fiducial Marker
2025-10-06
Sirius MRI Marker NS - The SIRIUS MRI Marker NS 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.
2017-09-15
Sirius 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.
2016-06-21
Sirius 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.
2016-02-19