FDA.reportPublic FDA data

QUALITY ELECTRODYNAMICS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30073507133007350713QUALITY ELECTRODYNAMICS1N2026-01-016655 Beta Drive Suite 100 Mayfield Village OH US 44143

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1953781485925694K24405416ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)MOS2025-02-28
1953781522711077K242006SureWave Elastography (Q7000225)LNH2025-02-12
1953781024582692K233656Contour ShoulderMOS2024-02-15
1953781147492800K233652Contour Hand/Wrist (Q7000232)MOS2024-02-16
1953781840961061K223429Contour KneeMOS2023-01-13
1953781996819735K201615SIGNA 7.0TLNH2020-10-15
1953781707659613K200477Flex Body SpeederMOS2020-04-08
1953781148716813K193140Flex Body SPEEDERMOS2020-01-03
1953781035027400K183111Contour 24MOS2018-12-07
1953781846582412K18169716ch Foot/ Ankle SPEEDERMOS2018-07-11
1953782012039540K17346916ch T/R Hand Wrist CoilMOS2018-01-09
1953781083904803K173446Contour 24MOS2017-11-17
1953781538894487K170840MAGNETOM TerraLNH2017-10-12
1953781238937608K163066TxRx Knee 15 Flare MR Coil 3.0TMOS2016-11-29
1953781163903389K162966TxRx Knee 15 Flare MR Coil 1.5TMOS2016-11-30
1953781024487965K1629468ch Knee-Foot SPEEDERMOS2017-01-06
1953781445861084K16262316ch T/R Hand Wrist CoilMOS2016-12-09
1953781334430771K16202916ch T/R Knee CoilMOS2016-10-18
1953781571545563K16119316ch Tx/Rx Knee SPEEDERMOS2016-06-02
1953781019453126K1526958 CH Knee SPEEDERMOS2015-11-18
1953781785347321K151829Atlas SPEEDER Header/NeckMOS2015-07-29
1953781203395118K15175316 ch Tx/Rx Knee SPEEDERMOS2015-08-27
1953781203752769K15033118ch T/R Knee CoilMOS2015-04-09
1953781179134967K142802Atlas SPEEDER Head/NeckMOS2014-11-24
1953781456388049K142002BREAST SPEEDER CX, GRID HOLDER CXMOS2014-08-22
1953781959985126K140998PEDIATRIC 16, A1.5T TIM COIL/PEDIATRIC 16, A3T TIM COILMOS2014-07-11
1953781452950613K122638TOSHIBA 3T 32CH HEAD SPEEDER COIL,MOS2012-09-25
1953781693808077K120627TOSHIBA 1.5T QD HEAD COILMOS2012-03-29
1953781916109487K120290TOSHIBA 1.5T CARDIAC COILMOS2012-02-28
1953781600987539K112313TOSHIBA 3T EXTRA LARGE KNEE COILMOS2011-09-09
1953781687967563K103185TOSHIBA 1.5T EXTRA LARGE KNEE COILMOS2011-02-25
1953781928143992K102489VANTAGE TITAN 3TLNH2011-08-02
1953781523973215K093667SHOULDER SPEEDER COILMOS2010-01-28
1953781244622507K091114TXRX 1.5T CP HEAD COIL; TXRX 3T CP HEAD COILMOS2009-05-01
1953781521669174K0831601.5T ATLAS SPEEDER HEAD-NECK COILMOS2008-11-07
1953781702773327K082636TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3TMOS2008-09-25
1953781164328694K072935SPEEDER 1.5T WRIST ARRAY COILMOS2007-10-31
1953781068508458
1953781279956306
1953781950014055

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MOS332025-02-28
LNH42025-02-12

PMN#