Allura 3D-CA 001009

GUDID 00884838059245

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.

Philips Medical Systems Nederland B.V.

Angiographic x-ray system application software
Primary Device ID00884838059245
NIH Device Record Keyd608ca57-210f-4e14-9a15-242abfd2f281
Commercial Distribution StatusIn Commercial Distribution
Brand NameAllura 3D-CA
Version Model NumberAllura 3D-CA R3
Catalog Number001009
Company DUNS413819707
Company NamePhilips Medical Systems Nederland B.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838059245 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-10-24
Device Publish Date2016-09-24

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00884838119284 - Philips Sentinelle2024-12-25 dS 3.0T Interface Box
00884838119291 - Philips Sentinelle2024-12-25 dS 1.5T 8CH Medial
00884838119307 - Philips Sentinelle2024-12-25 dS 3.0T 8CH Medial

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