FDA.report

Randy Vader

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30059305503005930550Randy Vader1N2026-01-0181 Hartwell Ave Ste 100 Lexington MA US 02421
30157465293015746529Randy Vader1N2026-01-0181 Hartwell Ave Ste 100 Lexington MA US 02421
30184233373018423337Randy Vader1N2026-01-0181 Hartwell Ave Ste 100 Lexington MA US 02421
30197845753019784575Randy Vader1N2026-01-0181 Hartwell Ave Ste 100 Lexington MA US 02421
30207070803020707080Randy Vader1N2026-01-0181 Hartwell Ave Ste 100 Lexington MA US 02421
30157465293015746529Randy Vader1N2020-04-2581 Hartwell Avenue, Suite 300 Lexington MA US 02421

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1361721529498580K254189Synapse 3D Base Tools (V7.2)QIH2026-04-30
1361721774381074K254075
2915931770968762K253862APERTO Lucent MRI SystemLNH2026-04-06
2915931970537071K251386ECHELON SynergyLNH2025-09-17
2915931095101272K250370SCENARIA View Phase 5.0JAK2025-05-20
1361721008171551K243762Synapse 3D Base Tools (V7.0)QIH2025-05-21
2915931560117658K241429ECHELON Synergy MRI SystemLNH2024-08-13
2915931308446383K240571OASIS MRI SystemLNH2024-04-12
2915931746920778K233687ECHELON Synergy V10.0LNH2024-05-03
2915931185681721K233629APERTO Lucent MRI SystemLNH2024-05-10
2915931166914806K233583FCT iSTREAM Phase 1JAK2024-04-26
2942871231231891K231941ARIETTA x10IYN2023-11-20
2915931402041504K223426ECHELON Synergy MRI systemLNH2023-07-13
1361721046233669K221677Synapse 3D Base Tools v6.6LLZ2022-11-10
2915931760389486K221619ECHELON Oval V6.2 MRI SystemLNH2023-01-26
2942871901082951K220295ARIETTA 50IYN2022-04-29
2915931564895720K213829SCENARIA ViewJAK2022-05-23
2915931887614146K211406OASIS MRI SystemLNH2021-10-07
2974441879237662K210625JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps ValveODC2021-09-10
2942871230519489K202422Arietta 65IYN2020-11-04
2915931893292896K202030OASIS MRI SystemLNH2020-10-21
1361721082036951K200973Synapse 3D Cardiac ToolsLLZ2020-08-27
2319391105992656K193123FUJIFILM Distal Cap Models 33-40FDS2019-12-11
1361721635842931K191544Synapse 3D Blood Flow AnalysisLLZ2019-10-18
2942871212317517K191233ARIETTA 750IYN2019-08-09
2915931202615603K190841SCENARIA ViewJAK2019-09-13
2942871930913618K190248ARIETTA 50IYN2019-04-02
2942871664306909K183456Aloka Arietta 850IYN2019-01-28
1361722042959559K181773Synapse 3D Optional ToolsLLZ2018-09-25
2942871646117350K181376ARIETTA 65IYN2018-07-18
1361721419018887K171463ASPIRE Bellus IILLZ2017-09-29
2915931399193721K163528HITACHI Supria Whole-body X-ray CT System Phase 3JAK2017-03-03
2942871156564689K163505ARIETTA PRECISIONIYN2017-05-30
2942871123664055K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersIYN2016-12-15
2942871595287013K162583ALOKA LISENDO 880IYN2016-11-17
1361721734472871K162287Synapse 3D Perfusion AnalysisLLZ2017-04-06
2942872071268906K160559NOBLUS™ Ultrasound Diagnostic SystemIYN2016-10-18
2915931639734541K150565Supria Whole-body X-ray CT SystemJAK2015-09-30
2942871389765943K142618Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound SystemITX2014-10-16
1361721189046698K142521Synapse 3D Liver and Kidney AnalysisLLZ2014-12-01
1361721518580140K141514SYNAPSE 3D TENSOR ANALYSISLLZ2014-09-03
2942871148901392K140854INTRA-OPERATIVE ULTRASOUND TRANSDUCERITX2014-06-11
2942871852358186K140443ARIETTA 60/ARIETTAS60/ARIETTAV60IYN2014-06-16
2942871217965337K134016ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNERIYN2014-03-28
1361721669919615K130542SYNAPSE 3D LUNG AND ABDOMEN ANALYSISLLZ2013-06-14
1361721454941324K130383SYNAPSE 3D CARDIAC TOOLSLLZ2013-04-09
2942871895192868K123828PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEMIYN2013-01-18
1361721880271689K123566SYNAPSE 3D COLON ANALYSISLLZ2013-01-22
2942871386117652K122537PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0IYN2013-04-12
2942871666540103K122341PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37IYN2012-09-26
1361721074364818K120679SYNAPSE 3D NODULE ANALYSISLLZ2012-06-01
1361721441363051K120637SYNAPSE 3D BRAIN PERFUSIONLLZ2012-05-08
1361721269746559K120361SYNAPSE 3D BASE TOOLSLLZ2012-04-06
1361721226709967K113244SYNAPSE MPR FUSIONLLZ2011-12-22
2915931560335119K113145ECHELON OVAL MRI SYSTEMLNH2012-05-01
1361721942384235K112439SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0LLZ2011-10-17
2942871611804595K110673HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNERIYN2011-09-27
2942871730634973K093488ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEMIYO2009-11-20
2942871077667322K083254ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEMIYN2008-12-19
2942871959054646K080176ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEMIYN2008-02-29
2915931245338392K080062OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120MOS2008-02-11
2915931678510262K073310OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT COILMOS2008-01-18
2942871111531474K072285ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEMITX2007-08-30
2915931570418304K072279MAGNETIC RESONANCE DIAGNOSTIC DEVICELNH2007-09-21
2915931155122536K063513ECHELON MR-RCC-150 CARDIAC COILMOS2006-12-12
2319391301674943
3447751030322329
3447751053053386
3447751248352409
2974441320271800
3447751532908906
3447751580581721
3447751722820992
3447751960072144

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
IYN192023-11-20
LLZ162022-11-10
LNH122026-04-06
JAK62025-05-20
ITX32014-10-16
MOS32008-02-11
QIH22026-04-30
ODC12021-09-10
FDS12019-12-11
IYO12009-11-20