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

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 softwareAn individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
063377717
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838130425Transducer V9-23000162230612026-04-14
00884838130432Transducer MC12-33000162230912026-04-14
00884838130449Transducer ML26-83000162231212026-04-14
00884838112988Affiniti 30 Diagnostic Ultrasound System7951802026-01-08
00884838124929Affiniti 30 Diagnostic Ultrasound System7951802026-01-08
00884838127098Affiniti 50 Diagnostic Ultrasound System7951182026-01-08
00884838127111EPIQ 5 Diagnostic Ultrasound System7951202026-01-08
00884838127128EPIQ Elite Diagnostic Ultrasound System7951252026-01-08
00884838126305EPIQ Diagnostic Ultrasound System7954182025-10-17
00884838126893EPIQ Diagnostic Ultrasound System7951222025-06-23
00884838126930EPIQ Diagnostic Ultrasound System7952322025-06-23
00884838124912EPIQ Elite Diagnostic Ultrasound System7952342024-12-19
00884838124974Affiniti 30 Diagnostic Ultrasound System7952182024-12-19
00884838124981Affiniti 50 Diagnostic Ultrasound System7952082024-12-19
00884838124998Affiniti 70 Diagnostic Ultrasound System7952102024-12-19
00884838125674Affiniti CVx Diagnostic Ultrasound System Circular Edition7954072024-06-12
00884838125643EPIQ CVx Diagnostic Ultrasound System7951222024-06-03
00884838125650EPIQ Series Diagnostic Ultrasound System7951172024-06-03
00884838123960EPIQ Diagnostic Ultrasound System7952312024-05-29
00884838123977EPIQ Diagnostic Ultrasound System7952322024-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860008194435Cycle ClarityCycle Clarity, LLCQIH2026-05-21
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
00860010264638EZRA PLEXO SOFTWAREEzra Ai, Inc.QIH2026-05-05
08437023642047NemoScanSOFTWARE NEMOTEC SLQIH2026-04-23
00860000171229SubtleSYNTHSubtle Medical, Inc.QIH2026-04-09
00860000171243SubtleHD(MR)Subtle Medical, Inc.QIH2026-04-09
08800124700136SwiftMRAIRS Medical Inc.QIH2026-04-01
G703AIORTAPLAN0AiORTA - PlanVitaa Medical Solutions Inc.QIH2026-03-30
B720BX360ECTA1210Brainomix 360 e-CTABRAINOMIX LIMITEDQIH2026-03-30
08800066200626MEDIHUB PROSTATEJLK, Inc.QIH2026-03-25
00884838122154EchoNavigatorPhilips Medical Systems Nederland B.V.QIH2026-03-25
10603295562108VELYS Hip NavigationDEPUY ORTHOPAEDICS, INC.QIH2026-03-24
08800130400303Neurophet AQUA AD PlusNEUROPHET Inc.QIH2026-02-24
G762AISAPCARDIOV10AISAP Cardio V1.0AISAP LTDQIH2026-02-18
B720BX360ECTA1420e-CTABRAINOMIX LIMITEDQIH2026-02-03
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.QIH2026-01-28
08800290041767EA2-11AVSAMSUNG MEDISON CO., LTD.QIH2026-01-28
08800290041811EA2-11ARSAMSUNG MEDISON CO., LTD.QIH2026-01-28
08800290042481PA2-9SSAMSUNG MEDISON CO., LTD.QIH2026-01-28
08800290042726CA2-13MSAMSUNG MEDISON CO., LTD.QIH2026-01-28
08800290065473EV2-12SAMSUNG MEDISON CO., LTD.QIH2026-01-28
00195278932358Spectral Bone MarrowGE Medical Systems, L.L.C.QIH2026-01-26
00198953113554LOGIQGE Ultrasound Korea Ltd.QIH2026-01-26
00198953113493LOGIQGE Ultrasound Korea Ltd.QIH2026-01-21