FDA.reportPublic FDA data

Randy Vader

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30157465293015746529Randy Vader1N2026-01-0181 Hartwell Ave Ste 100 Lexington MA US 02421
30184233373018423337Randy 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 key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2915931770968762K253862APERTO Lucent MRI SystemLNH2026-04-06
2915931970537071K251386ECHELON SynergyLNH2025-09-17
2915931095101272K250370SCENARIA View Phase 5.0JAK2025-05-20
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
2915931402041504K223426ECHELON Synergy MRI systemLNH2023-07-13
2915931760389486K221619ECHELON Oval V6.2 MRI SystemLNH2023-01-26
2915931564895720K213829SCENARIA ViewJAK2022-05-23
2915931887614146K211406OASIS MRI SystemLNH2021-10-07
2974441879237662K210625JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps ValveODC2021-09-10
2915931893292896K202030OASIS MRI SystemLNH2020-10-21
2319391105992656K193123FUJIFILM Distal Cap Models 33-40FDS2019-12-11
2915931202615603K190841SCENARIA ViewJAK2019-09-13
2915931399193721K163528HITACHI Supria Whole-body X-ray CT System Phase 3JAK2017-03-03
2915931639734541K150565Supria Whole-body X-ray CT SystemJAK2015-09-30
2915931560335119K113145ECHELON OVAL MRI SYSTEMLNH2012-05-01
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
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 code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LNH122026-04-06
JAK62025-05-20
MOS32008-02-11
ODC12021-09-10
FDS12019-12-11