C4 IMAGING, LLC

Address:196 W Ashland St Ste 109,Doylestown,PA,18901,US

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- Catalog Number : F-01-01-0001

Device Description : The SIRIUS MRI Marker is a component device indicated as an accessory for use in 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.

Device Class : 2

Duns Number: 003065466

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

- Catalog Number : F-01-01-0001

Device Description : The SIRIUS MRI Marker is a component device indicated as an accessory for use in 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.

Device Class : 2

Duns Number: 003065466

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

Device Description : The SIRIUS MRI Marker NS is a component device indicated as an accessory for use 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.

Device Class : 2

Duns Number: 003065466

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

Device Description : The HDR MRI Lumen Marker is a sealed high-density polyethylene (HDPE) tube conta 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.

Device Class : 2

Duns Number: 003065466

Premarket Exempt : No

Product Code : JAQ

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The Fiducial Marker consists of a sealed polyether ether ketone (PEEK) polymer c 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.

Device Class : 2

Duns Number: 003065466

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The Fiducial Marker consists of a sealed polyether ether ketone (PEEK) polymer c 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.

Device Class : 2

Duns Number: 003065466

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

Device Class : 2

Duns Number: 003065466

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1