Medical Device Manufacturer · US , Mayfield Village , OH

Quality Electrodynamics - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 2007

Recent clearances: 16ch Flex SPEEDER Medium 1.5T (Q7000246), Contour Hand/Wrist (Q7000232), Contour Shoulder

13

Total

13

Cleared

0

Denied

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

13 devices

1-12 of 13

Cleared Feb 28, 2025

16ch Flex SPEEDER Medium 1.5T (Q7000246)

Radiology · 59d

Cleared Feb 16, 2024

Contour Hand/Wrist (Q7000232)

Radiology · 94d

Cleared Feb 15, 2024

Contour Shoulder

Radiology · 93d

Cleared Sep 25, 2012

TOSHIBA 3T 32CH HEAD SPEEDER COIL,

Radiology · 27d

Cleared Mar 29, 2012

TOSHIBA 1.5T QD HEAD COIL

Radiology · 28d

Cleared Feb 28, 2012

TOSHIBA 1.5T CARDIAC COIL

Radiology · 28d

Cleared Sep 09, 2011

TOSHIBA 3T EXTRA LARGE KNEE COIL

Radiology · 29d

Cleared Feb 25, 2011

TOSHIBA 1.5T EXTRA LARGE KNEE COIL

Radiology · 120d

Cleared Jan 28, 2010

SHOULDER SPEEDER COIL

Radiology · 62d

Cleared May 01, 2009

TXRX 1.5T CP HEAD COIL

Radiology · 14d

Cleared Nov 07, 2008

1.5T ATLAS SPEEDER HEAD-NECK COIL

Radiology · 11d

Cleared Sep 25, 2008

TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T

Radiology · 15d