3G Transducer 101

GUDID B6691010

3rd generation MRIaudio Premium Transducer. Provides patients with high fidelity sound. 1.5 and 3 Tesla tested. Includes pneumatic tubing.

MRIAUDIO, INC.

Patient audiovisual communication/entertainment system

• Primary Device ID: B6691010
• NIH Device Record Key: 22e07687-56b0-4c07-8096-2391e3d287f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3G Transducer
• Version Model Number: 101
• Catalog Number: 101
• Company DUNS: 026681280
• Company Name: MRIAUDIO, 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B6691010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180100

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: 2026-03-16
• Device Publish Date: 2026-03-06

On-Brand Devices [3G Transducer]

• B6691011: 3rd generation MRIaudio Premium Transducer. Provides patients with high fidelity sound. 1.5 and
• B6691010: 3rd generation MRIaudio Premium Transducer. Provides patients with high fidelity sound. 1.5 and