3D-RA 001102

GUDID 00884838084766

Software medical device, used with a Philips Interventional X-Ray System. Creates 3D views of vessels and bones from sets of 2D images from rotational angiographic runs.

Philips Medical Systems Nederland B.V.

Angiographic x-ray system application software
Primary Device ID00884838084766
NIH Device Record Key587a306c-0059-47ed-8723-c20e496b6eb2
Commercial Distribution StatusIn Commercial Distribution
Brand Name3D-RA
Version Model Number3D-RA R6
Catalog Number001102
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838084766 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OWBInterventional Fluoroscopic X-Ray System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number7
Public Version Date2019-10-24
Device Publish Date2017-03-28

Devices Manufactured by Philips Medical Systems Nederland B.V.

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