FDA.reportPublic FDA data

GENORAY CO., LTD.

Matched from indexed company URL: Genoray Co.,Ltd

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30058434183005843418GENORAY CO., LTD.1N2026-01-0160, Dunchon-daero 541beon-gil, Jungwon-gu Seongnam-si Gyeonggi KR 13212

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
708192003124924K252229BELLIGER ACEOWB2026-04-02
708191904027645K250060GT300; GT300-COAS2025-10-08
708191809644571K243420HESTIAMUE2025-07-17
708191768202573K232158GenX-CRMUH2023-09-13
708191319369154K232085DVAS (DVAS-M, DVAS-W)EHD2023-12-08
708191517994959K230787Oscar 15 & Oscar 15iOWB2023-07-20
708191970973006K220423PAPAYA & PAPAYA PlusMUH2022-05-19
708191021722160K220392PAPAYA 3D & PAPAYA 3D PlusOAS2022-05-19
708192066806785K211780ZEN-2090 TurboOWB2022-03-09
708192039762685K200469PAPAYA 3D Premium & PAPAYA 3D Premium PlusOAS2020-09-16
708191038926988K181943OSCAR (OSCAR Prime, OSCAR Classic)OWB2018-08-17
708191880791738K172810PORT-X IVEHD2018-03-07
708191133770868K172180OSCAR 15OWB2018-02-09
708191522616893K150354PAPAYA 3D PlusOAS2015-12-10
708191093990189K141700PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEMMUH2014-10-31
708191906969462K140041ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEMOWB2014-11-28
708191646304444K130419PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEMMUH2013-11-06
708191876395656K130088PORT VIEW, DIGITAL X-RAY SENSOR SYSTEMMUH2013-07-18
708191383016167K120263VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEMMUH2012-07-10
708191820503816K103182TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMLLZ2011-01-14
708191193506412K103181ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMLLZ2011-08-26
708191955014971K092171VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEMMUH2010-04-26
708191033196143K091918ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PROOWB2009-10-07
708191458951327K063121PORTABLE X-RAY SYSTEM, MODEL PORT-X IIEHD2007-01-11

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OWB102026-04-02
MUH82023-09-13
EHD52023-12-08
OAS42025-10-08
LLZ22011-08-26
MUE12025-07-17

PMN#

HESTIA

2025-07-17

Genoray Co., Ltd.

GUDID#

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