FDA.reportPublic FDA data

ORT400 Table

Primary DI
00857534006691
Brand
ORT400 Table
Company
IMRIS Imaging, Inc.
Model
119900-000
Device description
ORT400 Table
Published
2024-10-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Product Codes#

Code, Name table
CodeName
GDCTable, Operating-Room, Electrical
KXJTable, Radiologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDCTable, Operating-Room, ElectricalGeneral, Plastic Surgery1
KXJTable, RadiologicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857534006691PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857534006691008575340066918575340066910857534006691

GMDN Terms#

Term, Definition table
TermDefinition
MRI system table, poweredA powered/programmable table designed with electronic and/or software controls to position and support a patient during magnetic resonance imaging (MRI) examinations. It is dedicated for use as part of an MRI system, as an integral component of the MRI system gantry, and made with ferromagnetically inactive materials to render it compatible with MRI environments. It may have a detachable table top, equipment supports, physiological monitors, mattresses, alarms and a patient positioning system (PPS).

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00857534006271VISIUSeye117532-0002024-10-04
00857534006295VISIUSeye117533-0002024-10-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953081839NAGE Medical Systems, L.L.C.KXJ2026-04-02
00198953081877NAGE Medical Systems, L.L.C.KXJ2026-04-02
00198953089835NAGE HEALTHCARE(TIANJIN) COMPANY LIMITEDKXJ2026-04-02
00198953089842NAGE HEALTHCARE(TIANJIN) COMPANY LIMITEDKXJ2026-04-02
00728564070009Assist Powered Medical Exam TableThe Brewer Company LLCGDC2025-11-10
00728564075004Assist Powered Medical Exam TableThe Brewer Company LLCGDC2025-11-10
00810050245562NADOMICO MED-DEVICE, LLCGDC2025-09-24
00724995244880NASTERIS CORPORATIONGDC2025-05-05
00724995244965NASTERIS CORPORATIONGDC2025-05-05
00724995245030CMAX XRAY Remote ControlSTERIS CORPORATIONGDC2025-05-05
00810050245487NADOMICO MED-DEVICE, LLCKXJ2023-05-01
00810050245463NADOMICO MED-DEVICE, LLCKXJ2023-01-13
10810050245415NADOMICO MED-DEVICE, LLCKXJ2022-10-24
00810101300028Schaerer Medical USASchaerer Medical Usa, Inc.GDC2022-09-16
00810101300035Schaerer Medical USASchaerer Medical Usa, Inc.GDC2022-09-16
10810050245316NADOMICO MED-DEVICE, LLCKXJ2022-05-31
00810050245296NADOMICO MED-DEVICE, LLCKXJ2022-05-27
10810050245231ScancoatDOMICO MED-DEVICE, LLCKXJ2022-04-01
10810050245200NADOMICO MED-DEVICE, LLCKXJ2022-03-11
10810050245118NADOMICO MED-DEVICE, LLCKXJ2021-12-17
10810050245002NADOMICO MED-DEVICE, LLCKXJ2021-11-29
10810050244890NADOMICO MED-DEVICE, LLCKXJ2021-11-02
10810050244920NADOMICO MED-DEVICE, LLCKXJ2021-11-02
10810050244814NADOMICO MED-DEVICE, LLCKXJ2021-10-07
10810050244845NADOMICO MED-DEVICE, LLCKXJ2021-10-07
10810050244852NADOMICO MED-DEVICE, LLCKXJ2021-10-07
10810050244753NADOMICO MED-DEVICE, LLCKXJ2021-09-27
10810050244715NADOMICO MED-DEVICE, LLCKXJ2021-09-13
10810050244623NADOMICO MED-DEVICE, LLCKXJ2021-08-20
10810050244562NADOMICO MED-DEVICE, LLCKXJ2021-07-30