FDA.reportPublic FDA data

Orlando Tadeo

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96146983002808382Orlando Tadeo1N2026-01-012441 Michelle Dr. Tustin CA US 92780

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3499131389947573K990490SSA-320A JUST VISION 200/ SSA-325A JUST VISIONIYO1999-03-02
3499131104607522K990134MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, TSX-101A (AQUILION,MULTI)JAK1999-03-19
3499131749652578K260078Aquilion ServeSP (TSX-307B) V2.0JAK2026-03-13
3499131322957970K253625Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MRLNH2026-03-27
3499131105806303K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemIYN2026-01-20
3499131972126761K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0JAK2026-05-20
3499131317708339K253584Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)OWB2026-03-10
3499131422421273K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemIYN2025-10-31
3499132046823134K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAPJAK2025-09-26
3499131461826770K251602Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingOWB2025-10-10
3499131211360375K251370Cartesion Prime (PCD-1000A/3) V10.21KPS2025-12-01
3499131160330443K250901Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MRLNH2025-07-22
3499131841392712K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramQIH2025-04-30
3499131017691468K243398CT Scanner TSX-501R/1 V11.1JAK2025-06-20
3499131220678334K243335Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MRLNH2025-01-07
3499132016200357K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5IYN2025-05-13
3499131550401388K242403Aquilion ONE (TSX-308A/3) V1.5JAK2024-12-23
3499131461311141K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)IYN2024-09-12
3499132033585959K241496Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MRLNH2024-08-20
3499131539821977K240705Vitrea Software Package, VSTP-002A V2.0LLZ2024-07-17
3499131740818501K240238Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MRLNH2024-04-12
3499131351181274K233334Aquilion Serve SP (TSX-307B/1) V1.3JAK2023-12-06
3499131229180799K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemIYN2024-01-24
3499131776504772K233107Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5OWB2024-08-30
3499132053934815K232988Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound SystemIYN2023-11-21
3499131268208444K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemJAK2024-04-02
3499131844748008K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5JAA2023-09-12
3499131029157940K231748Cartesion Prime (PCD-1000A/3) V10.15KPS2023-09-12
3499131430262821K231281Aquilion Serve (TSX-307A/1) V1.3JAK2023-09-19
3499131803361613K230355Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MRLNH2023-08-30
3499131084591083K223336Vitrea Software Package, VSTP-002ALLZ2023-01-09
3499132024271341K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0IYN2023-03-31
3499131904993780K222968Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MRLNH2022-10-25
3499131599906414K222819Aquilion Serve (TSX-307A/1) V1.2 with AiCE-iJAK2023-03-03
3499131599204240K222387Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MRLNH2022-08-31
3499131320309706K220986Aquilion Precision (TSX-304A/4) V10.10 with AiCEJAK2022-09-12
3499131420867368K220342XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3OWB2022-09-27
3499132065507875K220335Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MRLNH2022-04-05
3499132066206735K220192Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MRLNH2022-04-08
3499131381255651K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001AJAK2022-06-16
3499131087576998K213305Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MRLNH2021-12-01
3499131806855909K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5IYN2022-03-22
3499131950802327K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5IYN2022-01-24
3499131731727940K212056Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MRLNH2021-08-04
3499131798829541K211828Aquilion Exceed LBJAK2021-09-10
3499131858606656K211633Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MRLNH2021-07-22
3499131784590586K211037Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MRLNH2021-05-17
3499131690882996K210900Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2OWB2021-04-12
3499131415760795K210340Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MRLNH2021-04-01
3499131353713134K210164Vantage Elan 1.5T, MRT-2020, V6.0LNH2021-03-10
3499131547472743K203553Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MRLNH2021-02-02
3499131691027044K203551Alphenix, INFX-8000V/B, /S, V9.1OWB2020-12-18
3499132027784797K203323Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MRLNH2021-03-04
3499131326760836K203314Cartesion Prime (PCD-1000A/3) V10.8KPS2021-04-23
3499131320173715K203312Vitrea Software Package, VSTP-001ALLZ2021-02-16
3499131278967911K203225Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging SystemJAK2021-03-24
3499131780563392K203053Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MRLNH2020-12-02
3499131516468076K203042Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-IJAK2020-12-10
3499131124062401K202767Vantage Orian 1.5T, MRT-1550, V6.0LNH2021-01-15
3499131155306396K202364Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1IYN2020-10-15
3499131844027411K202349Cartesion Prime, PCD-1000A, V10.7KPS2020-10-15
3499131902770440K202210Vantage Orian 1.5T, MRT-1550, V6.0LNH2020-09-22
3499131185225466K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1IYN2020-10-08
3499131681773220K201836Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-iJAK2021-01-12
3499131491647747K193097Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MRLNH2020-07-14
3499131794480876K193021Vantage Orian 1.5T, MRT-1550, V6.0LNH2020-06-03
3499131117480946K192832Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-iJAK2020-02-21
3499131294575951K192828Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging SystemJAK2020-02-13
3499131272567518K192574Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MRLNH2020-03-09
3499131988184564K192506Vantage Galan 3T, MRT-3020, V6.0LNH2020-03-02
3499131374834546K192188Aquilion ONE (TSX-306A/3) V10.0JAK2019-09-06
3499131013632204K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0IYN2019-09-18
3499131264408045K191662Vantage Orian 1.5T, MRT-1550, V4.5LNH2019-07-23
3499131278485137K191582Cartesion PrimeKPS2019-08-13
3499131695941655K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0IYN2019-07-19
3499131711024297K191128Vantage Titan 3T, MRT-3010, V2.5LNH2019-06-26
3499131710125208K183657Vantage Galan 3T, MRT-3020/A9, V5.0LNH2019-03-15
3499131720504372K183046Aquilion ONE (TSX-305A/6) V8.9 with AiCEJAK2019-06-12
3499131404735781K182901Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCEJAK2019-07-05
3499131428736326K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1IYN2018-10-31
3499131678173399K182596Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound SystemIYN2018-11-02
3499131828089554K182546Alphenix, INFX-8000H/B, V8.0OWB2018-10-17
3499131269849660K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemIYN2018-11-02
3499131059248635K182415Alphenix, INFX-8000F/B, V8.0OWB2018-09-28
3499131370477210K182282Vantage Orian 1.5T, MRT-1550, V4.5LNH2018-10-19
3499131669805063K182223Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034AJAK2018-09-14
3499131494727496K181834Ultimax-i, DREX-UI80 (V1.60)OWB2018-07-19
3499131768669434K181804Alphenix, INFX-8000C/B, V8.0OWB2018-08-02
3499131724762481K181670Alphenix, INFX-8000V/B, V8.0OWB2018-07-25
3499131066037059K181646Celesteion, PCA-9000A/3, V6.5JAK2018-11-16
3499131031818022K181593Vantage Galan 3T, MRT-3020/A7, V5.0LNH2018-08-13
3499131185477546K181415XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0OWB2018-09-10
3499131678093326K173962Viamo c100 TUS-VC100 Diagnostic Ultrasound SystemIYN2018-04-20
3499132051096002K173468Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0JAK2018-02-23
3499131144557977K173382Vantage Galan 3T, V4.6LNH2018-01-26
3499131515461673K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4IYN2018-01-11
3499131139135432K172878Vantage Titan 3T, MRT-3010/A7, M-Power GXLNH2017-11-17
3499131539826288K172863Infinix-i, INFX-8000V, V7.0OWB2017-12-14
3499131354485086K172646XIDF-AWS801, Angio Workstation, V7.0OWB2017-10-30
3499131359403578K172276Xario 200 Diagnostic Ultrasound System V6.0IYN2017-12-12
3499131534400998K172188Aquilion Prime SP, TSX-303B/1, v8.4JAK2017-10-06
3499131215893386K171597Vantage Elan 1.5T, V4.0LNH2017-07-21
3499131146187329K171222Vitrea Software Toshiba Package; VSTP-001ALLZ2017-06-08
3499131805890664K170909Infinix INFX-8000V, V6.40OWB2017-06-16
3499131345596269K170832Ultimax-i, DREX-UI80 V1.60OWB2017-07-21
3499131750755447K170490Celesteion, PCA-9000A/3KPS2017-06-01
3499131059118428K170412Vantage Titan 1.5T, MRT-1510, M-Power GXLNH2017-06-07
3499131210600717K170177Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1JAK2017-06-30
3499131139269271K170019Aquilion Lightning, TSX-036A/1, V8.4JAK2017-02-02
3499131301357451K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1IYN2017-05-30
3499131614304778K162614Infinix, INFX-8000V, V6.35OWB2016-10-17
3499131001921968K162187Xario 100 Diagnostic Ultrasound System, V5.0IYN2016-09-30
3499132021691162K162183Vantage Galan 3T, MRT-3020, V4.0LNH2016-11-25
3499131572136043K162155Xario 200 Diagnostic Ultrasound System V5.0IYN2016-11-01
3499131531608779K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0IYN2016-09-21
3499131088302885K161009Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4JAK2016-07-22
3499131635884967K160632Vantage Titan 1.5T, MRT-1510, V3.6 SoftwareLNH2016-08-23
3499131729225060K160587Aquilion ONE (TSX-305A/3) V7.3JAK2016-06-09
3499131833239685K153263Aquilion Lightning, TSX-035A/4 and /5, V7.0JAK2016-04-01
3499131777234831K152785XIDF-AWS801, Angio Workstation, V6.20OWB2015-11-25

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JAK552026-05-20
LNH492026-03-27
IYN402026-01-20
OWB262026-03-10
LLZ92024-07-17
JAA82023-09-12
KPS72025-12-01
MOS62012-08-17
ITX42011-02-02
MQB32012-10-09
IYO32012-08-16
QIH12025-04-30