FDA.reportPublic FDA data

Q-Station

Primary DI
00884838086623
Brand
Q-Station
Company
Philips Ultrasound LLC
Model
Release 3.8.5
Published
2017-09-13
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
LLZSystem, image processing, radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140808000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140808000Q-STATIONPhilips Ultrasound, Inc.2014-04-17LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838086623PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838086623008848380866238848380866230884838086623

GMDN Terms#

Term, Definition table
TermDefinition
Radiology 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. It is designed specifically for use within radiology.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
063377717
Device count
1
DM exempt
true
Serial number
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
04260483290305MeVis AVM ContourMeVis Medical Solutions AGLLZ2026-07-09
G775EVOLVE4140EVOLVESmaart Medical Systems, Inc.LLZ2026-07-09
080563044562053mensio WorkstationPie Medical Imaging B.V.LLZ2026-07-08
00850059977576TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977583TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977590TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977606TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977613TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977521TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977538TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977545TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977552TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977569TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00889024673403NavitrackER®Orthosoft IncLLZ2026-06-26
00889024699762ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699779ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699786ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699793ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699809ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699816ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699823ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00860012615308Denti.AI Auto-ChartDenti.AI Technology IncLLZ2026-06-24
00860012615315Denti.AI DetectDenti.AI Technology IncLLZ2026-06-24
00850631008872Roentgen WorksBrit Systems, LLCLLZ2026-06-23
00628184004500Intellijoint VIEWIntellijoint Surgical IncLLZ2026-06-09
00860005144082Brain AgeDeephealth, Inc.LLZ2026-06-08
07649997938038Swissmeda Dental Planning SystemSwissmeda AGLLZ2026-06-08
07649997938052Swissmeda Dental Planning SystemSwissmeda AGLLZ2026-06-08
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-06-05
00850631008865Roentgen WorksBrit Systems, LLCLLZ2026-06-05