SureWave Elastography

GUDID 00814848020775

QUALITY ELECTRODYNAMICS LLC

Magnetic resonance elastography acoustic driver

• Primary Device ID: 00814848020775
• NIH Device Record Key: 265fb940-f529-473c-8595-882535c668ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureWave Elastography
• Version Model Number: Q7000225
• Company DUNS: 614760119
• Company Name: QUALITY ELECTRODYNAMICS LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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	00814848020775 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242006

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: 2025-04-21
• Device Publish Date: 2025-04-12

Devices Manufactured by QUALITY ELECTRODYNAMICS LLC

• 00814848020775 - SureWave Elastography: 2025-04-21
• 00814848020775 - SureWave Elastography: 2025-04-21
• 00814848020799 - Contour Shoulder: 2025-04-11
• 00814848020782 - 16ch T/R Hand Wrist Coil: 2024-07-26
• 00814848020508 - Shape Coil: 2021-08-30
• 00814848020546 - Shape Coil: 2021-08-30
• 00814848020515 - 2Tx 28Rx Knee Coil: 2021-02-22
• 00814848020423 - Contour 24: 2020-03-05
• 00814848020003 - 18ch T/R Knee Coil: 2020-03-05