FDA.reportPublic FDA data

QLAB Advanced Quantification Software

Primary DI
00884838122277
Brand
QLAB Advanced Quantification Software
Company
Philips Ultrasound LLC
Model
795041
Device description
VM11.0 update
Published
2024-05-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QIHAutomated Radiological Image Processing SoftwareRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838122277PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838122277008848381222778848381222770884838122277

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS-dedicated management softwareA software program dedicated for installation on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of a broad range of radiological images throughout the healthcare system. As a PACS-dedicated software, it is not primarily intended for diagnosis support, triage, or treatment planning. It does not incorporate adaptive/dynamic machine learning (ML) models.

Regulatory Flags#

DUNS number
063377717
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838128095Affiniti 50 Diagnostic Ultrasound System7952082026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound System7952102026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound System7952182026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound System7952342026-09-18
00884838129276Ultrasound Workspace7.0.X2025-08-29
00884838125186Ultrasound Workspace6.0.2.02025-03-24
00884838124233TOMTEC ARENATTA2.532024-07-03
00884838115323QLAB Advanced Quantification SoftwareRelease 15.67950412024-04-03
00884838121423TOMTEC ARENATTA27951302023-07-19
00884838115958Philips FetView7952682023-03-23
00884838103603QLAB Advanced Quantification Software9896067204412021-12-13
00884838098220Qlab Quantification Software9896067100712020-12-10
00884838102903Qlab Quantification Software 13.09896054964822020-12-10
00884838091672QLAB Advanced Quantification Software9896054964812019-06-27
00884838059788QLAB Quantification SoftwareRelease 10.52016-03-31
00884838070837QLAB Quantification SoftwareRelease 10.72017-02-01
00884838078079Q-StationRelease 3.72017-02-01
00884838083493QLAB Advanced Ultrasound Quantification SoftwareRelease 10.82017-04-13
00884838083509Q-Station Application SoftwareRelease 3.82017-04-13
00884838084322QLAB Advanced Quantification Software9896054650512018-06-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
08437021722109ADAS 3DADAS3D MEDICAL S.L.QIH2026-09-18
B720BX360HYPERDENSI1440Brainomix 360 HyperdensityBRAINOMIX LIMITEDQIH2026-09-18
00860016420922AI-CVDHeart Lung CorporationQIH2026-09-04
04262352350059DS Core CBCT AnatomyZetta25 AGQIH2026-08-26
00884838129924AV Cardiovascular Suite V1Philips Medical Systems Nederland B.V.QIH2026-08-23
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.QIH2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.QIH2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.QIH2026-08-18
00860006305734See-Mode TechnologiesSEE-MODE TECHNOLOGIES PTE. LTD.QIH2026-08-07
04068151012453syngo.CT Coronary CockpitSiemens Healthcare GmbHQIH2026-07-17
04068151034202syngo DynamicsSiemens Healthineers AGQIH2026-07-16
04068151086584LungMapsSiemens Healthineers AGQIH2026-06-24
03663999000429VEA AlignEOS IMAGINGQIH2026-06-12
04068151049923MI View&GOSIEMENS MEDICAL SOLUTIONS USA, INC.QIH2026-06-10
04068151018226syngo Application SoftwareSiemens Healthcare GmbHQIH2026-05-15
00754016387128ANDIImeka Solutions IncQIH2026-05-14
00860013927820Overjet Iris Intelligent Imaging SystemOverjet, Inc.QIH2026-05-13
08437021722093ADAS 3DADAS3D MEDICAL S.L.QIH2026-05-12
00198715128956AngiowaveAngioWave Imaging, LLCQIH2026-05-09
07613336231098Opulus Lymphoma PrecisionRoche Molecular Systems, Inc.QIH2026-05-08
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.QIH2026-05-06
B720BX360ECTA1430e-CTABRAINOMIX LIMITEDQIH2026-05-06
04262352351605DS Core DiagnosisZetta25 AGQIH2026-04-30
08437023642047NemoScanSOFTWARE NEMOTEC SLQIH2026-04-23
08800124700136SwiftMRAIRS Medical Inc.QIH2026-04-01
G703AIORTAPLAN0AiORTA - PlanVitaa Medical Solutions Inc.QIH2026-03-30