# Quality Electrodynamics, LLC

- Location (FDA's records): Mayfield Village, OH
- FDA decisions: 34 (2007–2025): 34 510(k) clearances
- Names in FDA's records: Quality Electrodynamics, LLC (21); Quality Electrodynamics (13)
- Product codes: MOS (33), LNH (1)
- 510(k) review time since 2016: median 59 days, against 42 for FDA's reviews in the same codes and years (7 of 17 faster)
- Predicates its devices cite: 41 (21 its own); citations of its devices by later devices: 26 (21 its own)
- Recalls linked to its devices: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Usa Instruments, Inc.: 6 (https://510kreport.com/company/usa-instruments)
- Mri Devices Corp.: 3 (https://510kreport.com/company/mri-devices)
- Invivo Corporation: 2 (https://510kreport.com/company/invivo)
- Resonance Innovations, LLC: 1 (https://510kreport.com/company/resonance-innovations)
- Advanced Imaging Research Dba Sree Medical Systems: 1 (https://510kreport.com/company/advanced-imaging-research-dba-sree-medical-systems)
- Medical Advances, Inc.: 1 (https://510kreport.com/company/medical-advances)
- Sentinelle Medical, Inc.: 1 (https://510kreport.com/company/sentinelle-medical)
- Toshiba America Medical Systems, In.C: 1 (https://510kreport.com/company/toshiba-america-medical-systems-in-c)

## Firms that cite its devices most
- Shanghai United Imaging Healthcare Co., Ltd.: 2 (https://510kreport.com/company/shanghai-united-imaging-healthcare)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Siemens Medi Cal Solutions, Inc.: 1 (https://510kreport.com/company/siemens-medi-cal-solutions)
- Toshiba America Medical Systems, In.C: 1 (https://510kreport.com/company/toshiba-america-medical-systems-in-c)

## Its most-cited devices
- K082636: TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3T (2008), cited by 4
- K150331: 18ch T/R Knee Coil (2015), cited by 3
- K083160: 1.5T Atlas Speeder Head-Neck Coil (2008), cited by 3
- K173446: Contour 24 (2017), cited by 2
- K223429: Contour Knee (2023), cited by 2
- K091114: TXRX 1.5T CP Head Coil; TXRX 3T CP Head Coil (2009), cited by 2

## Recent decisions
- K244054: 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) (Feb 28, 2025)
- K242006: SureWave Elastography (Q7000225) (Feb 12, 2025)
- K233652: Contour Hand/Wrist (Q7000232) (Feb 16, 2024)
- K233656: Contour Shoulder (Feb 15, 2024)
- K223429: Contour Knee (Jan 13, 2023)
- K200477: Flex Body Speeder (Apr 8, 2020)
- K193140: Flex Body SPEEDER (Jan 3, 2020)
- K183111: Contour 24 (Dec 7, 2018)

Source page: https://510kreport.com/company/quality-electrodynamics