FDA.reportPublic FDA data

iCT

Primary DI
00857534006219
Brand
iCT
Company
IMRIS Imaging, Inc.
Model
iCT System
Device description
iCT System 115219-000
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K130224000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130224000ICTImris, Inc.2013-07-18JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857534006219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857534006219008575340062198575340062190857534006219

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079990922
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857534006882Horseshoe Headrest116098-0002026-08-21
00857534006899Horseshoe Headrest116099-0002026-08-21
00850085914002IMRISeyeP1225062026-05-07
00857534006318Horseshoe HeadrestHorseshoe Headrest HFD100 Assembly2016-10-01
00857534006325Horseshoe HeadrestHorseshoe Headrest HFD200 Assembly2016-10-01
00857534006929Neuro II-SE105000-00X2026-03-20
00857534006110iMRX SystemAnt Assy, 1.5T 16CH Cardiac Coil2016-09-23
00857534006127iMRX SystemPOSTERIOR ASSY, 3T 16CH CARDIAC COIL2016-09-23
00857534006141iMRX SystemANTERIOR ASSY, 3T 16CH CARDIAC COIL2016-11-04
00857534006158iMRX SystemPost Assy, 1.5T 16CH Cardiac Coil2016-11-04
00857534006165iMRX SystemiMRX System AR-DR-OR2016-11-04
00857534006172iMRX SystemiMRX System AR-DR-AR2016-09-23
00857534006189iMRX SystemiMRX System AR-DR MR30RS2016-09-23
00857534006851InVision™ 3T Recharge Operating SuiteP1221812025-09-18
00857534006868IMRISmatrix 5.0P1223092025-09-18
00857534006875IMRISmatrix 5.0P1223102025-09-18
00857534006370InSitu Coil, 3TInSitu Coil, Open 3T2016-11-23
00857534006714Patient Support Board119749-0002020-09-18
00857534006837Horseshoe Headrest116668-0002024-11-01
00857534006844Horseshoe Headrest116961-0002024-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-06-05
10810068810940MONARCH™ Advanced Imaging Accessory KitAuris Health, Inc.JAK2026-06-02
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.JAK2026-05-27
00850025268424Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-05-12
00850025268400Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-02-27
00850025268394Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-01-21
00850025268387Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-11-03
00850025268370Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-09-24
00850025268349Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-07-11
00850025268363Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-06-03
00850025268356Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-05-23
00850025268332Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-05-16
08800025300299AVIEWCORELINE SOFT CO.,LTD.JAK2025-03-27
08800025300367AVIEW CACCORELINE SOFT CO.,LTD.JAK2025-03-24
00850025268318Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-03-21
00850025268325Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-11-21
00850025268301Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-09-20
00850025268257Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-09-05
00850025268295Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-08-13
10884521837102ILLUMISITECovidien LPJAK2024-08-09
10884521837126ILLUMISITECovidien LPJAK2024-08-09
10884521837133ILLUMISITECovidien LPJAK2024-08-09
10884521837140ILLUMISITECovidien LPJAK2024-08-09
10884521837157ILLUMISITECovidien LPJAK2024-08-09
10884521842915ILLUMISITECovidien LPJAK2024-08-09
07640167220021CAS-One IR Consumable Set GeneralCAScination AGJAK2024-06-17
00850025268240Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-05-02
08800025300237AVIEW CACCORELINE SOFT CO.,LTD.JAK2024-04-25
00850025268233Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-04-12
00850025268226Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-01-29