Medical Device Manufacturer · US , Mayfield Village , OH

Quality Electrodynamics, LLC - FDA 510(k) Cleared Devices

21 submissions · 21 cleared · Since 2014

Recent clearances: SureWave Elastography (Q7000225), Contour Knee, Flex Body Speeder

21

Total

21

Cleared

0

Denied

FDA 510(k) Regulatory Record - Quality Electrodynamics, LLC Radiology ✕

21 devices

1-12 of 21

Cleared Feb 12, 2025

SureWave Elastography (Q7000225)

Radiology · 218d

Cleared Jan 13, 2023

Radiology · 60d

Cleared Apr 08, 2020

Flex Body Speeder

Radiology · 41d

Cleared Jan 03, 2020

Flex Body SPEEDER

Radiology · 51d

Cleared Dec 07, 2018

Radiology · 29d

Cleared Jul 11, 2018

16ch Foot/ Ankle SPEEDER

Radiology · 14d

Cleared Jan 09, 2018

16ch T/R Hand Wrist Coil

Radiology · 62d

Cleared Nov 17, 2017

Radiology · 11d

Cleared Jan 06, 2017

8ch Knee-Foot SPEEDER

Radiology · 77d

Cleared Dec 09, 2016

16ch T/R Hand Wrist Coil

Radiology · 80d

Cleared Nov 30, 2016

TxRx Knee 15 Flare MR Coil 1.5T

Radiology · 37d

Cleared Nov 29, 2016

TxRx Knee 15 Flare MR Coil 3.0T

Radiology · 27d