FDA.reportPublic FDA data

ULTRASOUND WORKSTATION PACKAGE

Primary DI
04987670100796
Brand
ULTRASOUND WORKSTATION PACKAGE
Company
CANON INC.
Model
TUW-U001S
Device description
ULTRASOUND WORKSTATION PACKAGE
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYLCollimator, dermatological, therapeutic x-ray
IYNSystem, imaging, pulsed doppler, ultrasonic
LLZSystem, image processing, radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYLCollimator, Dermatological, Therapeutic X-RayRadiology2
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121076000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121076000ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGEToshiba America Medical Systems, In.C2012-10-09LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987670100796PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987670100796049876701007964987670100796

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound imaging system workstationA freestanding image processing workstation specifically designed to be networked with one or more diagnostic ultrasound imaging systems. It is sometimes considered to be a component to a picture archiving and communication system (PACS). An ultrasound workstation differs from the operator's console in that it does not contain the controls for the direct operation of the diagnostic imaging system. It is designed to receive and transmit data both on-line and off-line and is typically located at a site remote from the operator console. It has the capability to further process, manipulate and/or view patient images and information collected from one or more ultrasounds.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1-8004211968xxx@xxx.xxx

Regulatory Flags#

DUNS number
690549662
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987670105005Vitrea Software PackageVSTP-002A2023-04-24
04987670106088CONVEX ARRAY TRANSDUCERPET-835LA2026-07-24
04987670100222INTERVENTIONAL ANGIOGRAPHY SYSTEMINFX-8000V2016-09-01
049876701013594ch Flex SPEEDERMJAJ-197A2016-09-01
04987670102493Vitrea Software Toshiba PackageVSTP-001A2018-03-02
04987670103360Vantage OrianMRT-15502018-11-30
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCUS-AME002026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCUS-ABE002026-06-01
04987670105579Aquilion ONETSX-308A2025-01-09
04987670103797CT SCANNERTSX-306A2021-11-01
04987670100741DIAGNOSTIC ULTRASOUND SYSTEMTUS-X100S2016-09-01
04987670100734DIAGNOSTIC ULTRASOUND SYSTEMTUS-X1002016-09-01
04987670100758DIAGNOSTIC ULTRASOUND SYSTEMTUS-X2002016-09-01
04987670100765DIAGNOSTIC ULTRASOUND SYSTEMTUS-X200S2016-09-01
04987670106095Aquilion Serve SPTSX-307B2024-07-04
04987670102721PHASED ARRAY TRANSDUCERPSU-60ST2026-03-01
04987670102745LINEAR ARRAY TRANSDUCERPLU-1003ST2026-03-01
04987670102752LINEAR ARRAY TRANSDUCERPLU-805ST2026-03-01
04987670102769PHASED ARRAY TRANSDUCERPSU-30ST2026-03-01
04987670102783LINEAR ARRAY TRANSDUCERPLU-704ST2026-03-01

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.IYN2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SIYN2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SIYN2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SIYN2026-09-21
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-09-21
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYN2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYN2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYN2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYN2026-09-18
08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00198953078747LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
00198953121382VolusonGE Ultrasound Korea Ltd.IYN2026-05-28
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00198953113493LOGIQGE Ultrasound Korea Ltd.IYN2026-01-21
00198953042731LOGIQGE Ultrasound Korea Ltd.IYN2025-12-05
00198953042748LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYN2025-12-05
00198953042755LOGIQGE Ultrasound Korea Ltd.IYN2025-12-05
00198953042762LOGIQGE Ultrasound Korea Ltd.IYN2025-12-05
00198953042779LOGIQGE Ultrasound Korea Ltd.IYN2025-12-05
00198953042793LOGIQGE Ultrasound Korea Ltd.IYN2025-12-05
00198953042816LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYN2025-12-05
00198953076873SenoIrisGE MEDICAL SYSTEMSLLZ2025-11-24
00198953001400VenueGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYN2025-11-17
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