FDA.reportPublic FDA data

N23 CCD System

Primary DI
08056600520334
Brand
N23 CCD System
Company
NICAL SPA
Model
N23
Catalog number
N2360NAR1
Published
2023-10-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JAASystem, X-Ray, Fluoroscopic, Image-Intensified

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K951261000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951261000DFI-1000 AND DVS-475 IMAGING DEVICESNical1996-03-15JAA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056600520334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056600520334080566005203348056600520334

GMDN Terms#

Term, Definition table
TermDefinition
Fluoroscopic x-ray system video image recording unitAn assembly of devices that are part of a fluoroscopic x-ray system and specifically designed to display x-ray images in real-time. It is often referred to as an x-ray imaging chain. It includes a video camera [charge-coupled device (CCD) or tube based], a video signal generator, and cabling used to convert the analogue image taken from the output raster of the x-ray image intensifier and to display it on one or more image display monitors [visual display unit (VDU)] for immediate viewing.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
435743877
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056600520044Nical Flat PanelNFP Digital detectorNF3024C002023-10-09
08056600520051Nical Flat PanelNFP Digital detectorNFPMD43352023-10-09
08056600520006Nical Smart MicroNPR SystemNSM1001EU2023-09-28
08056600520013Nical Smart MicroNPR SystemNSM1001US2023-09-28
08056600520020Nical Smart MicroNPR SystemNSM1002EU2023-09-28
08056600520037Nical Smart MicroNPR SystemNSM1002US2023-09-28
08056600521331Nical Smart MicroNPR SystemNSM1001AA2023-09-28
08056600521348Nical Smart MicroNPR SystemNPR1000AA2023-09-28
08056600521355Nical Smart MicroNPR SystemNPR1000VE2023-09-28
08056600520303N23 CCD SystemN23N2360NANA2023-10-11
08056600520310N23 CCD SystemN23N2360NAN12023-10-11
08056600520327N23 CCD SystemN23N2360NARA2023-10-11
08056600520341N23 CCD SystemN23N2360NINA2023-10-11
08056600520358N23 CCD SystemN23N2360NIN12023-10-11
08056600520365N23 CCD SystemN23N2360NIRA2023-10-11
08056600520372N23 CCD SystemN23N2360NIR12023-10-11
08056600520389N23 CCD SystemN23N2360NHNA2023-10-11
08056600520396N23 CCD SystemN23N2360NHN12023-10-11
08056600520402N23 CCD SystemN23N2360NHRA2023-10-11
08056600520419N23 CCD SystemN23N2360NHR12023-10-11

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