FDA.reportPublic FDA data

HDR MRI Lumen Marker

Primary DI
00863593000235
Brand
HDR MRI Lumen Marker
Company
C4 IMAGING, LLC
Model
F-01-02-0001
Device description
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.
Published
2018-06-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JAQSystem, Applicator, Radionuclide, Remote-Controlled

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAQSystem, Applicator, Radionuclide, Remote-ControlledRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180069000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180069000HDR MRI Lumen MarkerC4 Imaging, LLC2018-04-27JAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863593000235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863593000235008635930002358635930002350863593000235

GMDN Terms#

Term, Definition table
TermDefinition
Imaging lesion localization marker, implantableA sterile device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. It is typically formed as a wire, needle, bead, stent-like tube or washer, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
036470387
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00863593000266Nova ZF-02-04-00112025-10-06
00863593000280Nova ZF-02-04-01112025-10-06
00863593000297Nova ZF-02-04-01112025-10-06
00863593000273Nova 10 Fiducial MarkerF-01-03-01152022-04-25
00863593000242Nova 5F-01-03-00112021-09-03
00863593000259Nova 5F-01-03-01112021-09-03
00863593000204Sirius MRI MarkerC-01-99-0014F-01-01-0001 2016-02-19
00863593000211Sirius MRI MarkerF-01-01-0001F-01-01-00012016-06-21
00863593000228Sirius MRI Marker NSF-01-01-00112017-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816389028081MAASTRO Rectal Applicator Set, ΓΈ 26 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-06-02
08717213014305NANucletron B.V.JAQ2019-02-02
08717213008472Shielded Cylindrical ApplicatorNucletron B.V.JAQ2018-07-11
08717213008892NANucletron B.V.JAQ2018-07-11
08717213008908NANucletron B.V.JAQ2018-07-11
08717213008915NANucletron B.V.JAQ2018-07-11
08717213009578Miami Vaginal ApplicatorNucletron B.V.JAQ2018-07-11
08717213009585Miami Vaginal ApplicatorNucletron B.V.JAQ2018-07-11
08717213009646Miami Vaginal ApplicatorNucletron B.V.JAQ2018-07-11
08717213007772Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213007796Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213007826Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213009660Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213009677Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213009691Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213010000Flexible Implant TubesNucletron B.V.JAQ2018-07-06
08717213010024Flexible Implant TubesNucletron B.V.JAQ2018-07-06
08717213009318Esophageal ApplicatorNucletron B.V.JAQ2018-06-27
08717213010666Flexible Implant TubesNucletron B.V.JAQ2018-06-27
08717213007765Esophageal ApplicatorNucletron B.V.JAQ2018-06-20
08717213009042Esophageal ApplicatorNucletron B.V.JAQ2018-06-20
08717213009059Esophageal ApplicatorNucletron B.V.JAQ2018-06-20
08717213013926Vaginal CT/MR ApplicatorNucletron B.V.JAQ2018-06-20
08717213008274MicroSelectron DigitalNucletron B.V.JAQ2018-06-14
08717213014022Standard CT/MR ApplicatorNucletron B.V.JAQ2018-06-09
08717213014039Standard CT/MR ApplicatorNucletron B.V.JAQ2018-06-09
08717213014145Ring CT/MR ApplicatorNucletron B.V.JAQ2018-06-09
08717213014152Ring CT/MR ApplicatorNucletron B.V.JAQ2018-06-09
08717213014169Ring CT/MR ApplicatorNucletron B.V.JAQ2018-06-09
08717213014206Ring CT/MR ApplicatorNucletron B.V.JAQ2018-06-09