IntelliSpace Radiology 836344

GUDID 00884838123809

IntelliSpace Radiology is a software package intended to be used by trained professionals, including but not limited to physicians, administrators and medical technicians. The software is used with general purpose computing hardware for the presentation, processing, measurement and distribution of images and associated data throughout a clinical environment. IntelliSpace Radiology software supports receiving, sending, printing, and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, CR, DX, DR, RF, RT, MG, SC, VL, and OP as well as hospital/radiology information systems. IntelliSpace Radiology contains an Advanced Mammography module for functionality specific to Mammography. Lossy compressed mammographic images and digitized film/screen images must not be reviewed for primary image interpretations.

Philips Medical Systems Nederland B.V.

Radiology picture archiving and communication system workstation
Primary Device ID00884838123809
NIH Device Record Key45937cec-e2dd-4b21-b799-ec52cfbc852f
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntelliSpace Radiology
Version Model Number4.7.X
Catalog Number836344
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 Datetrue
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
GS100884838123809 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-12
Device Publish Date2024-04-04

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