FDA.reportPublic FDA data

uWS

Primary DI
06971576834143
Brand
uWS
Company
Shanghai United Imaging Healthcare Co., Ltd.
Model
uWS-MR
Device description
MR Image Post-processing Software
Published
2022-06-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192601000
K220332000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192601000uWS-MRShanghai United Imaging Healthcare Co., Ltd.2020-06-01QIH
K220332000uMR Omega with uWS-MR-MRSShanghai United Imaging Healthcare Co., Ltd.2022-10-27LNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971576834143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971576834143069715768341436971576834143

GMDN Terms#

Term, Definition table
TermDefinition
MRI system application softwareAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a magnetic resonance imaging (MRI) system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855) 221-1552CustomerSuccess@united-imaging.com

Regulatory Flags#

DUNS number
421271328
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971576834334uWSuWS-Angio Pro2026-03-08
06971576834341uWSuWS-Angio2026-03-08
06971576834327uWSuWS-Angio Basic2025-08-02
06971576832033uMIuMI 7802025-08-03
06971576832170uMIuMI Panorama 352023-03-20
06971576832057uMIuMI 5502020-07-09
06971576832026uMIuMI 5502019-04-03
06971576832040uEXPLORERuEXPLORER2019-03-29
06971576833702uDRuDR Arria2026-03-08
06971576833719uDRuDR Aris2026-03-08
06971576830435uMRuMR Jupiter2024-07-31
06971576830107uMRuMR 6802023-09-21
06971576834150uWSuWS-CT2022-06-19
06971576834013uWSuWS-MR2019-12-10
06971576834020uWSuWS-CT2019-12-10
06971576834037uWSuWS-MI2019-12-10
06971576831340uCTuCT ATLAS Astound2023-02-28
06971576833689uDRuDR Aurora CX2025-11-19
06971576830527uMRuMR Ultra2025-08-03
06971576832163uMIuMI Panorama 282025-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260456230215CHILI PACSCHILI GmbHLLZ2026-09-25
B141MEDISSUITEMRCT20260Medis Suite MRCTMedis Medical Imaging Systems B.V.LLZ2026-09-25
00195278985613NAGE Medical Systems (China) Co.,Ltd.QIH2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SQIH2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SQIH2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SQIH2026-09-21
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-09-21
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.LLZ2026-09-18
08437021722109ADAS 3DADAS3D MEDICAL S.L.QIH2026-09-18
B720BX360HYPERDENSI1440Brainomix 360 HyperdensityBRAINOMIX LIMITEDQIH2026-09-18
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00860016420922AI-CVDHeart Lung CorporationQIH2026-09-04
00889024707092OrthoGrid®Orthogrid Systems, Inc.QIH2026-07-15
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00754016387128ANDIImeka Solutions IncQIH2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00198953113493LOGIQGE Ultrasound Korea Ltd.QIH2026-01-21
00198953042731LOGIQGE Ultrasound Korea Ltd.QIH2025-12-05
00198953042755LOGIQGE Ultrasound Korea Ltd.QIH2025-12-05
00198953042762LOGIQGE Ultrasound Korea Ltd.QIH2025-12-05
00198953042779LOGIQGE Ultrasound Korea Ltd.QIH2025-12-05
00198953042793LOGIQGE Ultrasound Korea Ltd.QIH2025-12-05
00198953076873SenoIrisGE MEDICAL SYSTEMSLLZ2025-11-24
00860003424841OrthoGrid Hip TraumaOrthogrid Systems, Inc.LLZ2025-06-24
00884838127746Radiology Operations Command Center ConsolePhilips Medical Systems Nederland B.V.LLZ2025-03-14
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10