FDA.reportPublic FDA data

Nova Z

Primary DI
00863593000280
Brand
Nova Z
Company
C4 IMAGING, LLC
Model
F-02-04-0111
Device description
Fiducial marker loaded needle assembly
Published
2025-10-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NEUMarker, Radiographic, Implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEUMarker, Radiographic, ImplantableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192771000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192771000C4 Fiducial MarkerC4 Imaging, LLC2020-10-21NEU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863593000280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863593000280008635930002808635930002800863593000280

GMDN Terms#

Term, Definition table
TermDefinition
Radiological image marker, implantableA device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiological images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, 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. It is not an electromagnetic or optical spatial marker.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
036470387
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00863593000266Nova ZF-02-04-00112025-10-06
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
00863593000235HDR MRI Lumen MarkerF-01-02-00012018-06-11
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

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Primary DI, Brand, Company table
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