Neuro II-SE

GUDID 00857534006929

Model 105000-00X include the following: 105000-000, OR-MB Configuration 105000-001, OR-DR Config 105000-002, OR-MB-DR Config 105000-003, OR-MB-OR Config 105000-004, OR-DR-OR Config 105119-001, Multi-Room Imaging Suite MR15L Oracle OR-DR 105087-000, Multi Room Imaging Suite, MR15LS OR-DR

IMRIS Imaging, Inc.

Full-body MRI system, superconducting magnet

• Primary Device ID: 00857534006929
• NIH Device Record Key: 9352edd2-8c9b-4bc9-9db1-06c1f2f61b54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neuro II-SE
• Version Model Number: 105000-00X
• Company DUNS: 079990922
• Company Name: IMRIS Imaging, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857534006929 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061916

FDA Product Code

• LNH: System, Nuclear Magnetic Resonance Imaging

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-30
• Device Publish Date: 2026-03-20

Devices Manufactured by IMRIS Imaging, Inc.

• 00857534006929 - Neuro II-SE: 2026-03-30Model 105000-00X include the following: 105000-000, OR-MB Configuration 105000-001, OR-DR Config 105000-002, OR-MB-DR Config 105000-003, OR-MB-OR Config 105000-004, OR-DR-OR Config 105119-001, Multi-Room Imaging Suite MR15L Oracle OR-DR 105087-000, Multi Room Imaging Suite, MR15LS OR-DR
• 00857534006929 - Neuro II-SE: 2026-03-30 Model 105000-00X include the following: 105000-000, OR-MB Configuration 105000-001, OR-DR Config 105000-002, OR-MB-DR Config 10
• 00857534006851 - InVision™ 3T Recharge Operating Suite: 2025-09-26 InVision™ 3T Recharge Operating Suite
• 00857534006868 - IMRISmatrix 5.0: 2025-09-26 Applications Platform 5.0 3 Room, North America, Japan
• 00857534006875 - IMRISmatrix 5.0: 2025-09-26 Applications Platform 5.0 2 Room, North America, Japan
• 00857534006714 - Patient Support Board: 2025-04-08 ORT 400 table, Patient Support Board with Label 119749-000