FDA.reportPublic FDA data

Patient Support Board

Primary DI
00857534006714
Brand
Patient Support Board
Company
IMRIS Imaging, Inc.
Model
119749-000
Device description
ORT 400 table, Patient Support Board with Label 119749-000
Published
2020-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe

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
00857534006714PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857534006714008575340067148575340067140857534006714

GMDN Terms#

Term, Definition table
TermDefinition
Basic diagnostic x-ray system table, poweredA powered/programmable table that is a component of a basic diagnostic x-ray system designed to position and support a patient during a variety of routine/planar or speciality diagnostic procedures requiring the use of a diagnostic x-ray system; it is not a planar tomography nor computed tomography (CT) table. It can be a stationary or mobile unit and is made of radiolucent materials with low x-ray attenuation coefficients. It is not intended for use during interventional radiology/surgery.

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
00857534006837Horseshoe Headrest116668-0002024-11-01
00857534006844Horseshoe Headrest116961-0002024-11-01
00857534006271VISIUSeye117532-0002024-10-04
00857534006295VISIUSeye117533-0002024-10-04
00857534006301VISIUSeye117535-0002024-10-04

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