FDA.reportPublic FDA data

Neuro II-SE

Primary DI
00857534006929
Brand
Neuro II-SE
Company
IMRIS Imaging, Inc.
Model
105000-00X
Device description
Model 105000-00X include the following: 105000-000, OR-MB Configuration105000-001, OR-DR Config105000-002, OR-MB-DR Config105000-003, OR-MB-OR Config105000-004, OR-DR-OR Config105119-001, Multi-Room Imaging Suite MR15L Oracle OR-DR105087-000, Multi Room Imaging Suite, MR15LS OR-DR
Published
2026-03-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Product Codes#

Code, Name table
CodeName
LNHSystem, Nuclear Magnetic Resonance Imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061916000
K071099000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061916000NEURO II-SE, MODELS OR-MB-DR AND OR-DRImris, Inc.2006-08-11LNH
K071099000NEURO II-SE, MODELS: OR-DR-OR, OR-MBImris, Inc.2007-05-22LNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857534006929PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857534006929008575340069298575340069290857534006929

GMDN Terms#

Term, Definition table
TermDefinition
Full-body MRI system, superconducting magnetA diagnostic general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body (full-body imaging). This system includes a superconducting magnet assembly and can be fixed-location, mobile, or transportable. Some systems can perform MR spectroscopy or various real-time imaging procedures for MRI guided interventional, therapeutic, or surgical applications. The system is available in a variety of system gantry configurations including closed bore, open bore, and open-sided or other kinds of patient accessible designs.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079990922
Device count
1
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04573596201367OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201398OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201404OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201411OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201435OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596202159OASISFUJIFILM CORPORATIONLNH2026-05-29
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.LNH2026-04-23
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.LNH2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.LNH2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.LNH2026-04-22
08720168162854Mask DSPS®-PROSCVRL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162861Mask DSPS®-PROSC set/5MACROMEDICS B.V.LNH2026-04-22
08720168162878Mask DSPS®-PROSCVR set/5MACROMEDICS B.V.LNH2026-04-22
08720168162885Mask DSPS®-PROSCL set/5MACROMEDICS B.V.LNH2026-04-22
08720168163356DSPS-Prominent® SH profile set/2MACROMEDICS B.V.LNH2026-04-22
08720168163387DSPS PRO Mask Shim Set HNSMACROMEDICS B.V.LNH2026-04-22
08720168163394DSPS PRO Mask Shim Set HOMACROMEDICS B.V.LNH2026-04-22
B319QSM1QSMetricIMAGING BIOMETRICS, LLCLNH2026-04-22
10841962119457Symphony Locating Bar, Prodigy2™QfixLNH2025-10-23
10841962119464Symphony Locating Bar, PH StyleQfixLNH2025-10-23
10841439114732PronumbraMEDTEC, INC.LNH2025-09-12
10841439114749PronumbraMEDTEC, INC.LNH2025-09-12
10841439114770PronumbraMEDTEC, INC.LNH2025-09-12
10841439114787PronumbraMEDTEC, INC.LNH2025-09-12
08056304455727G-scan OpenESAOTE SPALNH2024-07-02
10841962119433Leg ExtensionQfixLNH2023-08-17
10841962119440Leg ExtensionQfixLNH2023-08-17
09355529000002FerriScan, Cardiac T2*RESONANCE HEALTH ANALYSIS SERVICES PTY LTDLNH2023-06-19