FDA.reportPublic FDA data

InfiMed Platinum One, DSA, CCD Camera

Primary DI
00858086006108
Brand
InfiMed Platinum One, DSA, CCD Camera
Company
INFIMED, INC.
Model
PlatinumOne DSA
Published
2016-09-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JAASystem, x-ray, fluoroscopic, image-intensified
OWBInterventional fluoroscopic x-ray system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2
OWBInterventional Fluoroscopic X-Ray SystemRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858086006108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858086006108008580860061088580860061080858086006108

GMDN Terms#

Term, Definition table
TermDefinition
X-ray system computer, diagnostic, general-purposeA dedicated mainframe computer, personal computer (PC) or PC based platform and associated hardware, firmware, and operating system software used specifically to control and monitor the operation of a general-purpose medical x-ray system and associated image processing, display and analysis functions.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
197117211
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858086006009InfiMed i5, DSA, CCD Camerai5 DSA2016-09-16
00858086006016InfiMed i5, DR, Digital Receptori5 DR2016-09-16
00858086006023InfiMed Nexus, RF/DR, Non Varian Digital ReceptorNexus DRF (RF/DR)2016-09-16
00858086006030InfiMed Nexus, RF/DR, Digital ReceptorNexus-DRF2016-09-16
00858086006047InfiMed Platinum One, RF, CCD CameraPlatinumOne RF2016-09-16
00858086006054InfiMed i5, RF, CCD Camerai5 RF2016-09-16
00858086006061InfiMed Precision RXi, RF/DSA, CCD CameraPrecision RXi D2016-09-16
00858086006078InfiMed Precision MPi, RF, CCD CameraPrecision MPi RF2016-09-16
00858086006085InfiMed Precision MPi, DSA, CCD CameraPrecision MPi DSA2016-09-16
00858086006092InfiMed Nexus, DR, Digital ReceptorNexus DR2016-09-20
00858086006115InfiMed Nexus, DR, v3.03.02016-09-20
00858086006122InfiMed Nexus, DRF, v2.52.52016-09-16

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