FDA.reportPublic FDA data

CATHETERIZATION TABLE

Primary DI
04987670100079
Brand
CATHETERIZATION TABLE
Company
CANON INC.
Model
CAT-860B
Published
2025-03-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OWBInterventional Fluoroscopic X-Ray System

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210900000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210900000Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2Canon Medical Systems Corporation2021-04-12OWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987670100079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987670100079049876701000794987670100079

GMDN Terms#

Term, Definition table
TermDefinition
Fluoroscopy/angiography table, poweredA powered table designed to support and position a patient during fluoroscopy/angiography typically in conjunction with a cardiovascular intervention or other minimally-invasive surgical intervention (e.g., biopsy). It has a flat table top with electronic controls for table top positioning and/or motion relative to the x-ray beam. It is not dedicated to breast biopsy, and is not intended for other specialized surgeries (i.e., it is not a specialized operating table with x-ray transparent features).

Sterilization Methods#

Method table
Method

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060508110057Cydar MapsCYDAR LIMITEDOWB2026-05-27
08055186671225A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08055186671232A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08055186671249A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08055186671256A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
00857088008684TrackXTrackX Technology, LLCOWB2026-05-11
00198715128956AngiowaveAngioWave Imaging, LLCOWB2026-05-09
08809365283033SG HealthcareSG Healthcare Co., Ltd.OWB2026-04-24
00841962120548Alpine Stirrups, Metric, LeftQfixOWB2026-04-14
00841962120555Alpine Stirrups, Metric, RightQfixOWB2026-04-14
08809244060533GenorayGENORAY CO., LTD.OWB2026-04-10
08809244060557GenorayGENORAY CO., LTD.OWB2026-04-10
08809244060632GenorayGENORAY CO., LTD.OWB2026-04-10
00850073646120TrackXTrackX Technology, LLCOWB2026-04-08
00850079606043MC2 Portable X-ray SystemOXOS Medical, Inc.OWB2026-03-25
00850079606050EmitterOXOS Medical, Inc.OWB2026-03-25
00850073646106TrackXTrackX Technology, LLCOWB2026-02-24
00198953052488AlliaGE MEDICAL SYSTEMSOWB2025-12-17
00841962120388Lumen AirShuttleQfixOWB2025-12-02
08809244060601GenorayGENORAY CO., LTD.OWB2025-12-01
00850073646045TrackXTrackX Technology, LLCOWB2025-10-24
00850073646052TrackXTrackX Technology, LLCOWB2025-10-24
00850073646069TrackXTrackX Technology, LLCOWB2025-10-24
00850073646076TrackXTrackX Technology, LLCOWB2025-10-24
00850073646083TrackXTrackX Technology, LLCOWB2025-10-24
00850073646113TrackXTrackX Technology, LLCOWB2025-10-15
00841962119467Alpine StirrupsQfixOWB2025-07-09
00841962119474Alpine StirrupsQfixOWB2025-07-09
08800018422601EXTRON 3DRTECH CorporationOWB2025-06-17
08809244060465GenorayGENORAY CO., LTD.OWB2025-05-02