FDA.reportPublic FDA data

INTERVENTIONAL ANGIOGRAPHY SYSTEM

Primary DI
04987670100222
Brand
INTERVENTIONAL ANGIOGRAPHY SYSTEM
Company
CANON INC.
Model
INFX-8000V
Device description
INTERVENTIONAL ANGIOGRAPHY SYSTEM
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
IZISystem, x-ray, angiographic
JAASystem, x-ray, fluoroscopic, image-intensified
OWBInterventional fluoroscopic x-ray system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZISystem, X-Ray, AngiographicRadiology2
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2
OWBInterventional Fluoroscopic X-Ray SystemRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081582000
K112054000
K120073000
K133535000
K143225000
K152696000
K162614000
K170909000
K172863000
K181670000
K203551000
K251602000
K253584000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081582000INFX-8000V, INFINIX-CFI AND INFINIX VFIToshiba America Medical Systems, In.C2008-06-17JAA
K112054000INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000VToshiba Medical Systems Corporation, Japan2011-08-05JAA
K120073000INFX-8000V WITHToshibamedical Systems Corporation2012-01-26OWB
K133535000INFX-8000V, V5.30Toshibamedical Systems Corporation2014-07-23OWB
K143225000INFX-8000V with Wireless FootswitchToshibamedical Systems Corporation2015-01-09OWB
K152696000INFX-8000V, V6.20Toshibamedical Systems Corporation2016-01-12OWB
K162614000Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation2016-10-17OWB
K170909000Infinix INFX-8000V, V6.40Toshiba Medical Systems Coroporation2017-06-16OWB
K172863000Infinix-i, INFX-8000V, V7.0Toshibamedical Systems Corporation2017-12-14OWB
K181670000Alphenix, INFX-8000V/B, V8.0Canon Medical Systems Corporation2018-07-25OWB
K203551000Alphenix, INFX-8000V/B, /S, V9.1Canon Medical Systems Corporation2020-12-18OWB
K251602000Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingCanon Medical Systems Corporation2025-10-10OWB
K253584000Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)Canon Medical Systems Corporation2026-03-10OWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987670100222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987670100222049876701002224987670100222

GMDN Terms#

Term, Definition table
TermDefinition
Stationary angiographic x-ray system, digitalA stationary diagnostic fluoroscopic x-ray system specifically designed to optimize the capability of users to visually and quantitatively evaluate the anatomy and function of blood vessels of the heart, brain and other organs, as well as the lymphatic system. It uses digital techniques for real-time image capture, display and manipulation and typically includes spot-film capabilities in addition to the fluoroscopic features. It is commonly used in conjunction with an injected x-ray contrast medium during either imaging or x-ray guided surgical or interventional procedures. Images can be viewed in both real-time and delayed formats.

Contacts#

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

Regulatory Flags#

DUNS number
690549662
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04987670102820CONVEX ARRAY TRANSDUCERPVU-366ST2026-03-01

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