FDA.reportPublic FDA data

3D-CA

Primary DI
00884838084773
Brand
3D-CA
Company
Philips Medical Systems Nederland B.V.
Model
3D-CA - 3
Catalog number
001109
Device description
Software medical device, used with a Philips Interventional X-Ray System. Creates a 3D model of the coronary vessel tree from a pair of 2D images from a rotational angiographic run.
Published
2017-03-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IZISystem, X-Ray, Angiographic
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZISystem, X-Ray, AngiographicRadiology2
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042334000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042334000ALLURA 3D-CA, RELEASE 1Philips Medical Systems North America Co.2004-09-27LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838084773PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838084773008848380847738848380847730884838084773

GMDN Terms#

Term, Definition table
TermDefinition
Angiographic x-ray system application softwareAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to an x-ray fluoroscopy based imaging system including x-ray angiography system configurations. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
413819707
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838123786Multimodality Simulation Workspace (MM Sim)1.0Multimodality Simulation Workspace (MM Sim)1.07283492026-06-07
00884838123793Multimodality Simulation Workspace (MM Sim)1.0 UpgradeMultimodality Simulation Workspace (MM Sim)1.0 Upg7283512026-06-07
00884838123748Spectral CT VeridaSpectral CT Verida7283452026-05-26
00884838126398Spectral CT Verida RTSpectral CT Verida RT7283572026-05-26
00884838127555Upgrade Spectral CT VeridaUpgrade Spectral CT Verida7283562026-05-26
00884838127562Upgrade Spectral CT Verida RTUpgrade Spectral CT Verida RT7283722026-05-26
00884838127876Upgrade Spectral CT 7500 SW5.4Upgrade Spectral CT 7500 SW5.47283752026-05-26
00884838127883Upgrades Spectral CT 7500 RT SW5.4Upgrades Spectral CT 7500 RT SW5.47283552026-05-26
00884838128187IngeniaBlueSeal SE7822132026-04-07
00884838128194IngeniaBlueSeal XE7822142026-04-07
00884838128200IngeniaIngenia Elition S7822162026-04-07
00884838128217IngeniaIngenia Elition X7822172026-04-07
00884838128224MR 7700MR 77007822182026-04-07
00884838128231IngeniaUpgrades dStream to R137822192026-04-07
00884838128248IngeniaEvolution Upgrade 1.5T7822202026-04-07
00884838128255IngeniaEvolution Upgrade 3.0T7822212026-04-07
00884838128262IngeniaSmartPath to Ingenia Elition X7822222026-04-07
00884838128293MR 7700Upgrade to MR 77007822252026-04-07
00884838128309MR 7700SmartPath to MR 77007822262026-04-07
00884838128316IngeniaBlueSeal QE7822152026-04-07

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