InVision™ 3T Recharge Operating Suite

GUDID 00857534006851

InVision™ 3T Recharge Operating Suite

IMRIS Imaging, Inc.

Full-body MRI system, superconducting magnet

• Primary Device ID: 00857534006851
• NIH Device Record Key: 1b6a8a2f-f9d1-4b3e-8ea7-91abd3ec0cd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InVision™ 3T Recharge Operating Suite
• Version Model Number: P122181
• 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	00857534006851 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252239

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: 2025-09-26
• Device Publish Date: 2025-09-18

Devices Manufactured by IMRIS Imaging, Inc.

• 00857534006851 - InVision™ 3T Recharge Operating Suite: 2025-09-26InVision™ 3T Recharge Operating Suite
• 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