| 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 Issuing Agency | Device ID | 
|---|---|
| GS1 | 00814848020775 [Primary] | 
| LNH | System, Nuclear Magnetic Resonance Imaging | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2025-04-21 | 
| Device Publish Date | 2025-04-12 | 
| 00814848020812 - 16ch Flex SPEEDER Medium 1.5T | 2025-05-28 | 
| 00814848020829 - 16ch Flex SPEEDER Large 1.5T | 2025-05-28 | 
| 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 |