QLAB Quantification Software

GUDID 00884838070837

Philips Ultrasound, Inc.

Radiology PACS software
Primary Device ID00884838070837
NIH Device Record Key071a4594-4f42-4489-b275-18bd380296dd
Commercial Distribution StatusIn Commercial Distribution
Brand NameQLAB Quantification Software
Version Model NumberRelease 10.7
Company DUNS063377717
Company NamePhilips Ultrasound, Inc.
Device Count1
DM Exempttrue
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
GS100884838070837 [Primary]

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 Number4
Public Version Date2019-05-23
Device Publish Date2017-02-01

On-Brand Devices [QLAB Quantification Software]

00884838086616Release 10.8.5
00884838070837Release 10.7
00884838059788Release 10.5
00884838098220989606710071

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