FDA.reportPublic FDA data

VISIUSeye

Primary DI
00857534006295
Brand
VISIUSeye
Company
IMRIS Imaging, Inc.
Model
117533-000
Device description
VISIUSeye - iMRI 3T V
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
FTYTape, Measuring, Rulers And Calipers

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTYTape, Measuring, Rulers And CalipersGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857534006295PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857534006295008575340062958575340062950857534006295

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding headrest, reusableA device designed to be placed on a flat surface (e.g., operating/examination table, stretcher) to support and stabilize the head of a recumbent patient, typically in preparation for and during many types of medical procedures or examinations; it is not attached to a parent device. The headrest is typically made of shock-absorbing materials (e.g., memory foam, gel) that cushion the head and is available in various sizes and shapes including head pad, head ring, and concave ergonomic holders with fingered lateral supports to position the head. This is a reusable device after appropriate cleaning.

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
00857534006301VISIUSeye117535-0002024-10-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809513720069SAEHAN Skinfold CaliperSaehan CorporationFTY2026-05-18
05055445928780SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
05055445928797SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
05055445928803SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
05055445928810SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
05055445928827SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
05055445928834SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
05055445928841SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
00850085914002IMRISeyeIMRIS Imaging, Inc.FTY2026-05-07
G4250010My MedicalMy Medical Store LLCFTY2026-05-04
G4250020My MedicalMy Medical Store LLCFTY2026-05-04
04719846011786CharderCHARDER ELECTRONIC CO., LTD.FTY2026-04-29
00190776418724MillenniumAvalign Technologies, Inc.FTY2026-04-09
00757770413607Bausch + LombBausch & Lomb IncorporatedFTY2026-03-31
00840117349827Durma+ DynaRule Disposable Paper RulersDynarex CorporationFTY2026-03-24
00842071152956AMT Balloon Measuring DeviceAPPLIED MEDICAL TECHNOLOGY, INC.FTY2026-02-20
00887868287510Trinica ALP Anterior Lumbar Plate SystemHighridge Medical, LLCFTY2025-11-12
03662663108027Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2025-11-12
03662663108034Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2025-11-12
03662663108041Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2025-11-12
03662663108058Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2025-11-12
03662663108065Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2025-11-12
03662663108096Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2025-11-12
08809986680198Magic RulerInnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)FTY2025-10-30
09348215165192Tendon RulerSIGNATURE ORTHOPAEDICS PTY LTDFTY2025-10-10
G79151202DMD000G0WishFIXRed Star Contract Manufacturing Inc.FTY2025-10-06
00371347019841Advance Dental ProductsThe Atlanta Dental Supply CompanyFTY2025-10-02
10197344154654MEDLINEMEDLINE INDUSTRIES, INC.FTY2025-07-28
04946585251672CROWNJUN Micro ScaleKONO SEISAKUSHO CO.,LTD.FTY2024-11-14
14026704920553KMEDICTELEFLEX INCORPORATEDFTY2024-07-15