FDA.reportPublic FDA data

ORT200

Primary DI
00857534006738
Brand
ORT200
Company
IMRIS Imaging, Inc.
Model
113821-000
Device description
ORT200 Covered Table Assembly V2
Published
2024-10-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Product Codes#

Code, Name table
CodeName
FQOTable, Operating-Room, Ac-Powered
KXJTable, Radiologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQOTable, Operating-Room, Ac-PoweredGeneral, Plastic Surgery1
KXJTable, RadiologicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857534006738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857534006738008575340067388575340067380857534006738

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
00850085914026VISIUSmatrix120906-0002026-10-16
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995362980STERISSTERIS CORPORATIONFQO2026-10-08
00724995362997STERISSTERIS CORPORATIONFQO2026-10-08
00724995363000STERISSTERIS CORPORATIONFQO2026-10-08
00724995363024STERISSTERIS CORPORATIONFQO2026-10-08
00724995363031STERISSTERIS CORPORATIONFQO2026-10-08
00724995363048STERISSTERIS CORPORATIONFQO2026-10-08
00724995363116STERISSTERIS CORPORATIONFQO2026-10-08
00724995363123STERISSTERIS CORPORATIONFQO2026-10-08
00724995363147STERISSTERIS CORPORATIONFQO2026-10-08
00724995363154STERISSTERIS CORPORATIONFQO2026-10-08
00724995363161STERISSTERIS CORPORATIONFQO2026-10-08
00724995363291NASTERIS CORPORATIONFQO2026-10-08
00724995363307NASTERIS CORPORATIONFQO2026-10-08
00724995363369NASTERIS CORPORATIONFQO2026-10-08
00724995363376NASTERIS CORPORATIONFQO2026-10-08
00724995363383NASTERIS CORPORATIONFQO2026-10-08
00724995363390NASTERIS CORPORATIONFQO2026-10-08
00724995363413NASTERIS CORPORATIONFQO2026-10-08
00724995363901NASTERIS CORPORATIONFQO2026-10-08
00724995363918NASTERIS CORPORATIONFQO2026-10-08
00198953255315NAGE Medical Systems, L.L.C.KXJ2026-07-08
00724995221577NASTERIS CORPORATIONFQO2026-06-24
00724995221584NASTERIS CORPORATIONFQO2026-06-24
00724995221591NASTERIS CORPORATIONFQO2026-06-24
00724995221607NASTERIS CORPORATIONFQO2026-06-24
00198953089835NAGE HEALTHCARE(TIANJIN) COMPANY LIMITEDKXJ2026-04-02
00198953089842NAGE HEALTHCARE(TIANJIN) COMPANY LIMITEDKXJ2026-04-02
00724995214074STERISSTERIS CORPORATIONFQO2023-11-17
00195278472083NAGE Medical Systems, L.L.C.KXJ2021-12-31
10810050245118NADOMICO MED-DEVICE, LLCKXJ2021-12-17