FDA.reportPublic FDA data

uWS

Primary DI
06971576834327
Brand
uWS
Company
Shanghai United Imaging Healthcare Co., Ltd.
Model
uWS-Angio Basic
Device description
Angiography X-ray Image Processing Software
Published
2025-08-02
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
K243632000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243632000uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.2025-05-12LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971576834327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971576834327069715768343276971576834327

GMDN Terms#

Term, Definition table
TermDefinition
Angiographic x-ray system application softwareAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to an x-ray fluoroscopy based imaging system including x-ray angiography system configurations. 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 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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
06971576834334uWSuWS-Angio Pro2026-03-08
06971576834341uWSuWS-Angio2026-03-08
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
06971576832231uMIuMI Panvivo2025-08-03

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Primary DI, Brand, Company table
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08437021468212QP-ProstateQUIBIM SOCIEDAD LIMITADA.LLZ2026-06-05
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G725QFR300QFRQFR Solutions B.V.LLZ2026-05-11
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G713ELU0010ElucisRealize Medical Inc.LLZ2026-05-07
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.LLZ2026-05-06
08437023642016NemoCastSOFTWARE NEMOTEC SLLLZ2026-04-23
08437023642023NemoFABSOFTWARE NEMOTEC SLLLZ2026-04-23
M722C26103V260970ClearRead CT ServerRiverain Technologies, Inc.LLZ2026-04-20
M722CC26103V260970ClearRead CT ConsoleRiverain Technologies, Inc.LLZ2026-04-20
EOLENEUROINSIGHTV1P00Neuro InsightOlea Medical USALLZ2026-04-13
EOLENEUROVASIV1P00Neurovascular InsightOlea Medical USALLZ2026-04-13
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08800290066784EVO Q10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340506147EVO QH10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340509988EVO XQ10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800066200619JLK-AILINKJLK, Inc.LLZ2026-03-25