Quality Electrodynamics LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 34
- Inspections
- 4
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0036-2020 | Class II | TxRx Knee 15 Coil 1.5T QED part number: Q7000056 Siemens Model # 10606828 | August 20, 2019 |
| Z-0031-2020 | Class II | TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460 | August 20, 2019 |
| Z-0032-2020 | Class II | TxRx 15CH Knee Coil 1.5T QED part number:Q7000016 Siemens Model # 10185453 | August 20, 2019 |
| Z-0035-2020 | Class II | TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525 | August 20, 2019 |
| Z-0033-2020 | Class II | TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464 | August 20, 2019 |
| Z-0034-2020 | Class II | TxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524 | August 20, 2019 |
| Z-0037-2020 | Class II | TxRx Knee 15 Coil 1.5T QED part number: Q7000057 Siemens Model # 10606829 | August 20, 2019 |
| Z-2314-2012 | Class II | TxRx Knee 15 Coil 3T. For use in conjunction with magnetic resonance scanners to produce diagnost | July 27, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K244054 | 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) | February 28, 2025 |
| K242006 | SureWave Elastography (Q7000225) | February 12, 2025 |
| K233652 | Contour Hand/Wrist (Q7000232) | February 16, 2024 |
| K233656 | Contour Shoulder | February 15, 2024 |
| K223429 | Contour Knee | January 13, 2023 |
| K200477 | Flex Body Speeder | April 8, 2020 |
| K193140 | Flex Body SPEEDER | January 3, 2020 |
| K183111 | Contour 24 | December 7, 2018 |
| K181697 | 16ch Foot/ Ankle SPEEDER | July 11, 2018 |
| K173469 | 16ch T/R Hand Wrist Coil | January 9, 2018 |
| K173446 | Contour 24 | November 17, 2017 |
| K162946 | 8ch Knee-Foot SPEEDER | January 6, 2017 |
| K162623 | 16ch T/R Hand Wrist Coil | December 9, 2016 |
| K162966 | TxRx Knee 15 Flare MR Coil 1.5T | November 30, 2016 |
| K163066 | TxRx Knee 15 Flare MR Coil 3.0T | November 29, 2016 |
| K162029 | 16ch T/R Knee Coil | October 18, 2016 |
| K161193 | 16ch Tx/Rx Knee SPEEDER | June 2, 2016 |
| K152695 | 8 CH Knee SPEEDER | November 18, 2015 |
| K151753 | 16 ch Tx/Rx Knee SPEEDER | August 27, 2015 |
| K151829 | Atlas SPEEDER Header/Neck | July 29, 2015 |