Medical Device Manufacturer · US , Mayfield Village , OH

Quality Electrodynamics

13 submissions · 13 cleared · Since 2007
13
Total
13
Cleared
0
Denied

Quality Electrodynamics — FDA 510(k) Submissions

Quality Electrodynamics has submitted 13 FDA 510(k) premarket notifications since 2007, of which 13 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Coil, Magnetic Resonance, Specialty . Use the specialty filter in the sidebar to narrow results.

13 devices
1–13 of 13
16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)
K244054 · MOS Coil, Magnetic Resonance,... · Radiology
Feb 2025 59d
Contour Hand/Wrist (Q7000232)
K233652 · MOS Coil, Magnetic Resonance,... · Radiology
Feb 2024 94d
Contour Shoulder
K233656 · MOS Coil, Magnetic Resonance,... · Radiology
Feb 2024 93d
TOSHIBA 3T 32CH HEAD SPEEDER COIL,
K122638 · MOS Coil, Magnetic Resonance,... · Radiology
Sep 2012 27d
TOSHIBA 1.5T QD HEAD COIL
K120627 · MOS Coil, Magnetic Resonance,... · Radiology
Mar 2012 28d
TOSHIBA 1.5T CARDIAC COIL
K120290 · MOS Coil, Magnetic Resonance,... · Radiology
Feb 2012 28d
TOSHIBA 3T EXTRA LARGE KNEE COIL
K112313 · MOS Coil, Magnetic Resonance,... · Radiology
Sep 2011 29d
TOSHIBA 1.5T EXTRA LARGE KNEE COIL
K103185 · MOS Coil, Magnetic Resonance,... · Radiology
Feb 2011 120d
SHOULDER SPEEDER COIL
K093667 · MOS Coil, Magnetic Resonance,... · Radiology
Jan 2010 62d
TXRX 1.5T CP HEAD COIL; TXRX 3T CP HEAD COIL
K091114 · MOS Coil, Magnetic Resonance,... · Radiology
May 2009 14d
1.5T ATLAS SPEEDER HEAD-NECK COIL
K083160 · MOS Coil, Magnetic Resonance,... · Radiology
Nov 2008 11d
TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T
K082636 · MOS Coil, Magnetic Resonance,... · Radiology
Sep 2008 15d
SPEEDER 1.5T WRIST ARRAY COIL
K072935 · MOS Coil, Magnetic Resonance,... · Radiology
Oct 2007 14d
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