FDA.reportPublic FDA data

Angio Workstation Software

Primary DI
04987670100451
Brand
Angio Workstation Software
Company
CANON INC.
Model
XIDF-AWS801
Device description
Angio Workstation Software
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
JAASystem, x-ray, fluoroscopic, image-intensified
OWBInterventional fluoroscopic x-ray system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2
OWBInterventional Fluoroscopic X-Ray SystemRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132106000
K141541000
K142736000
K150967000
K152785000
K172646000
K181415000
K220342000
K232526000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132106000INFINIX ANGIO WORKSTATION W/DTS SOFTWAREToshiba America Medical Systems, In.C2013-11-12JAA
K141541000XIDF-AWS801, ANGIO WORKSTATION, V5.31Toshibamedical Systems Corporation2014-09-08JAA
K142736000XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation2015-03-11OWB
K150967000XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation2015-06-18OWB
K152785000XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation2015-11-25OWB
K172646000XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation2017-10-30OWB
K181415000XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0Canon Medical Systems Corporation2018-09-10OWB
K220342000XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Canon Medical Systems Corporation2022-09-27OWB
K232526000XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5Canon Medical Systems Corporation2023-09-12JAA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987670100451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987670100451049876701004514987670100451

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic x-ray digital imaging system workstation application softwareAn individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to a diagnostic x-ray system workstation so that it may function according to its intended purpose, e.g., for the rendering, visualization and manipulation of medical images to support the image display needs of clinicians, diagnosticians and technicians. A basic set of applications programs and routines are included with the multi-purpose diagnostic x-ray system workstation and can be upgraded to correct programming errors or to add new system capabilities.

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
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
04987670102806CW DOPPLER PENCIL TRANSDUCERPC-20ST2026-03-01
04987670102813DIAGNOSTIC ULTRASOUND SYSTEMTUS-VC1002026-03-01

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