FDA.reportPublic FDA data

CT SCANNER

Primary DI
04987670103797
Brand
CT SCANNER
Company
CANON INC.
Model
TSX-306A
Published
2021-11-01
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

Product Codes#

Code, Name table
CodeName
JAKSystem, X-Ray, Tomography, Computed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143294000
K192188000
K192828000
K203225000
K213504000
K253596000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143294000Adaptive Motion Correction (AMC), CSMC-001A and 4D AirwaysToshibamedical Systems Corporation2015-05-15JAK
K192188000Aquilion ONE (TSX-306A/3) V10.0Canon Medical Systems Corporation2019-09-06JAK
K192828000Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging SystemCanon Medical Systems Corporation2020-02-13JAK
K203225000Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging SystemCanon Medical Systems Corporation2021-03-24JAK
K213504000Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation2022-06-16JAK
K253596000Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation2026-05-20JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987670103797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987670103797049876701037974987670103797

GMDN Terms#

Term, Definition table
TermDefinition
Full-body CT systemAn assembly of diagnostic x-ray computed tomography (CT) devices with a gantry large enough to allow imaging of any part of the body. It includes designs with single or multiple fixed annular arrays of x-ray tubes and opposing detectors or those with x-ray tube(s) and opposing detector assemblies that rotate rapidly around a central axis point within the gantry imaging area. It can produce two and/or three-dimensional (3-D) cross-sectional (tomographic) images, including spiral CT or other special imaging applications at multiple specified angles in relation to body position. It may use a variety of digital techniques for information capture, image reconstruction, and display.

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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810068810940MONARCH™ Advanced Imaging Accessory KitAuris Health, Inc.JAK2026-06-02
00860015781918iCAC DeviceBunkerhill Health Inc.JAK2026-05-31
10884521785977superDimensionCovidien LPJAK2026-05-29
10884521851184superDimensionCovidien LPJAK2026-05-29
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.JAK2026-05-27
10810068810858MONARCH™ ControllerAuris Health, Inc.JAK2026-05-27
M722CD26112CA252790ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2026-05-07
B319LSN1LSNIMAGING BIOMETRICS, LLCJAK2026-04-14
B720BX360ELUNG230Brainomix 360 e-LungBRAINOMIX LIMITEDJAK2026-03-30
08719326703824LungQ®Thirona B.V.JAK2026-02-12
10841962119457Symphony Locating Bar, Prodigy2™QfixJAK2025-10-23
10841962119464Symphony Locating Bar, PH StyleQfixJAK2025-10-23
M722C25281CA252790ClearRead CT CAC ServerRiverain Technologies, Inc.JAK2025-10-17
M722CC25281CA252790ClearRead CT CAC ConsoleRiverain Technologies, Inc.JAK2025-10-17
M722CD25281CA252790ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2025-10-17
10810068811275Extended Patient Introducer MountAuris Health, Inc.JAK2025-09-04
10810068810896Monarch Bronchscope 2.0/Monarch Platform (P2), RefurbishedAuris Health, Inc.JAK2025-08-04
10810068811169Monarch Platform, Bronchoscopy 4.1, RefurbishedAuris Health, Inc.JAK2025-08-04
10810068811497Monarch™ Tower Software v4.1.1Auris Health, Inc.JAK2025-06-04
10810068811503Monarch™ Cart Software v4.1.1Auris Health, Inc.JAK2025-06-04
10884521852198superDimensionCovidien LPJAK2025-05-18
08800025300299AVIEWCORELINE SOFT CO.,LTD.JAK2025-03-27
08800025300367AVIEW CACCORELINE SOFT CO.,LTD.JAK2025-03-24
10810068810971Monarch Endoscopy ControllerAuris Health, Inc.JAK2025-03-05
10810068810988Monarch Platform, Bronchoscopy 4.1Auris Health, Inc.JAK2025-03-03
10810068810582Monarch™ Tower Software v4.1.0Auris Health, Inc.JAK2025-03-03
10810068810599Monarch™ Cart Software v4.1.0Auris Health, Inc.JAK2025-03-03
M722CD25030CA241430ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2025-02-12
04987670105579Aquilion ONECANON INC.JAK2025-01-09
07640167220021CAS-One IR Consumable Set GeneralCAScination AGJAK2024-06-17