FDA.reportPublic FDA data

IMRISeye

Primary DI
00850085914002
Brand
IMRISeye
Company
IMRIS Imaging, Inc.
Model
P122506
Device description
ALIGNMENT RING ASSEMBLY, SSF
Published
2026-05-07
Public version status
New
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
00850085914002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850085914002008500859140028500859140020850085914002

GMDN Terms#

Term, Definition table
TermDefinition
Radiological general body-part positionerA device intended to facilitate adequate positioning and immobilization of a patient’s body part during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures; it is not dedicated to a specific part of the body. The device is in the form of a frame, board, cushion, or preformed pad that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.

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
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
00857534006301VISIUSeye117535-0002024-10-04

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Primary DI, Brand, Company table
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05055445928841SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
05055445928858SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
G4250010My MedicalMy Medical Store LLCFTY2026-05-04
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