FDA.reportPublic FDA data

Ultrasound Workspace

Primary DI
00884838125186
Brand
Ultrasound Workspace
Company
Philips Ultrasound LLC
Model
6.0.2.0
Published
2025-03-24
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
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
LLZSystem, Image Processing, Radiological
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
LLZSystem, Image Processing, RadiologicalRadiology2
QIHAutomated Radiological Image Processing SoftwareRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838125186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838125186008848381251868848381251860884838125186

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
true
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
00884838124233TOMTEC ARENATTA2.532024-07-03
00884838122277QLAB Advanced Quantification Software7950412024-05-29
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
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYN2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYN2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYN2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYN2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
08437021722109ADAS 3DADAS3D MEDICAL S.L.QIH2026-09-18
08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
B720BX360HYPERDENSI1440Brainomix 360 HyperdensityBRAINOMIX LIMITEDQIH2026-09-18
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00860016420922AI-CVDHeart Lung CorporationQIH2026-09-04
00198953078747LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
00198953121382VolusonGE Ultrasound Korea Ltd.IYN2026-05-28
00754016387128ANDIImeka Solutions IncQIH2026-05-14
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00198953113493LOGIQGE Ultrasound Korea Ltd.QIH2026-01-21
00198953113493LOGIQGE Ultrasound Korea Ltd.IYN2026-01-21
00198953042731LOGIQGE Ultrasound Korea Ltd.IYN2025-12-05
00198953042731LOGIQGE Ultrasound Korea Ltd.QIH2025-12-05
00198953042748LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYN2025-12-05
00198953042755LOGIQGE Ultrasound Korea Ltd.IYN2025-12-05
00198953042755LOGIQGE Ultrasound Korea Ltd.QIH2025-12-05
00198953042762LOGIQGE Ultrasound Korea Ltd.IYN2025-12-05
00198953042762LOGIQGE Ultrasound Korea Ltd.QIH2025-12-05
00198953042779LOGIQGE Ultrasound Korea Ltd.IYN2025-12-05
00198953042779LOGIQGE Ultrasound Korea Ltd.QIH2025-12-05
00198953042793LOGIQGE Ultrasound Korea Ltd.IYN2025-12-05