Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Quality Electrodynamics — Predicate Candidate Screening

13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

28 daysmedian FDA review time

94 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K244054	16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER	Quality Electrodynamics	2025-02-28	59	0
K233652	Contour Hand/Wrist (Q7000232)	Quality Electrodynamics	2024-02-16	94	0
K233656	Contour Shoulder	Quality Electrodynamics	2024-02-15	93	0
K122638	TOSHIBA 3T 32CH HEAD SPEEDER COIL,	Quality Electrodynamics	2012-09-25	27	0
K120627	TOSHIBA 1.5T QD HEAD COIL	Quality Electrodynamics	2012-03-29	28	0
K120290	TOSHIBA 1.5T CARDIAC COIL	Quality Electrodynamics	2012-02-28	28	0
K112313	TOSHIBA 3T EXTRA LARGE KNEE COIL	Quality Electrodynamics	2011-09-09	29	0
K103185	TOSHIBA 1.5T EXTRA LARGE KNEE COIL	Quality Electrodynamics	2011-02-25	120	0
K093667	SHOULDER SPEEDER COIL	Quality Electrodynamics	2010-01-28	62	0
K091114	TXRX 1.5T CP HEAD COIL; TXRX 3T CP HEAD COIL	Quality Electrodynamics	2009-05-01	14	0
K083160	1.5T ATLAS SPEEDER HEAD-NECK COIL	Quality Electrodynamics	2008-11-07	11	1
K082636	TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T	Quality Electrodynamics	2008-09-25	15	1
K072935	SPEEDER 1.5T WRIST ARRAY COIL	Quality Electrodynamics	2007-10-31	14	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda