FDA.reportPublic FDA data

uWS

Primary DI
06971576834150
Brand
uWS
Company
Shanghai United Imaging Healthcare Co., Ltd.
Model
uWS-CT
Device description
CT 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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203448000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203448000uCT ATLAS with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.2021-08-11JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971576834150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971576834150069715768341506971576834150

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/ disc burning) and/or image manipulation and quantification (e.g., non-interpretive graphical overlays).

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

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
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
06971576832231uMIuMI Panvivo2025-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05420060351235TRUMATCHMaterialise NVLLZ2026-10-22
05420060351242TRUMATCHMaterialise NVLLZ2026-10-22
05420060351259TRUMATCHMaterialise NVLLZ2026-10-22
05420060351266TRUMATCHMaterialise NVLLZ2026-10-22
05420060351273TRUMATCHMaterialise NVLLZ2026-10-22
05420060351280TRUMATCHMaterialise NVLLZ2026-10-22
05420060351297TRUMATCHMaterialise NVLLZ2026-10-22
05420060351303TRUMATCHMaterialise NVLLZ2026-10-22
05420060351310TRUMATCHMaterialise NVLLZ2026-10-22
05420060351327TRUMATCHMaterialise NVLLZ2026-10-22
05420060351334TRUMATCHMaterialise NVLLZ2026-10-22
05420060351341TRUMATCHMaterialise NVLLZ2026-10-22
05420060351358TRUMATCHMaterialise NVLLZ2026-10-22
05420060351365TRUMATCHMaterialise NVLLZ2026-10-22
05420060351372TRUMATCHMaterialise NVLLZ2026-10-22
05420060351389TRUMATCHMaterialise NVLLZ2026-10-22
05420060351396TRUMATCHMaterialise NVLLZ2026-10-22
05420060351402TRUMATCHMaterialise NVLLZ2026-10-22
B621ICOBRAINCTP1X7Y0icobrain ctpicometrix NVLLZ2026-10-22
00850631008919Roentgen WorksBrit Systems, LLCLLZ2026-10-21
00850631008926Roentgen WorksBrit Systems, LLCLLZ2026-10-21
05420060351228TruMatch CMF Titanium 3D Printed SplintsMaterialise NVLLZ2026-10-20
TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F1B80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F34K0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F6000PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7300PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7940PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7F80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F9F00PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20