FDA.reportPublic FDA data

Orlando Tadeo

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96146983002808382Orlando Tadeo1N2027-01-0110500 Cedar Ave Cleveland OH US 44106
30127615443012761544Orlando Tadeo1N2027-01-0110500 Cedar Ave Cleveland OH US 44106

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
3520681389947573K990490SSA-320A JUST VISION 200/ SSA-325A JUST VISIONIYO1999-03-02
3499131104607522K990134MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, TSX-101A (AQUILION,MULTI)JAK1999-03-19
3520681104607522K990134MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, TSX-101A (AQUILION,MULTI)JAK1999-03-19
3499131749652578K260078Aquilion ServeSP (TSX-307B) V2.0JAK2026-03-13
3520681749652578K260078Aquilion 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
3520681322957970K253625Vantage 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
3520681105806303K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemIYN2026-01-20
3499131972126761K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0JAK2026-05-20
3520681972126761K253596Aquilion 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
3520681317708339K253584Alphenix, 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
3520681422421273K252074Aplio 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
3520682046823134K251645Self-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
3520681461826770K251602Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingOWB2025-10-10
3499131211360375K251370Cartesion Prime (PCD-1000A/3) V10.21KPS2025-12-01
3520681211360375K251370Cartesion 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
3520681160330443K250901Vantage 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
3520681841392712K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramQIH2025-04-30
3499131017691468K243398CT Scanner TSX-501R/1 V11.1JAK2025-06-20
3520681017691468K243398CT Scanner TSX-501R/1 V11.1JAK2025-06-20
3499131220678334K243335Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MRLNH2025-01-07
3520681220678334K243335Vantage 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
3520682016200357K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5IYN2025-05-13
3499131550401388K242403Aquilion ONE (TSX-308A/3) V1.5JAK2024-12-23
3520681550401388K242403Aquilion 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
3520681461311141K241582Aplio 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
3520682033585959K241496Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MRLNH2024-08-20
3520681591346202K241049CANON Fundus Camera CR-10 (CR-10)HKI2024-05-15
3499131539821977K240705Vitrea Software Package, VSTP-002A V2.0LLZ2024-07-17
3520681539821977K240705Vitrea 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
3520681740818501K240238Vantage 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
3520681351181274K233334Aquilion Serve SP (TSX-307B/1) V1.3JAK2023-12-06
3499131229180799K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemIYN2024-01-24
3520681229180799K233195Aplio 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
3520681776504772K233107Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5OWB2024-08-30
3499132053934815K232988Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound SystemIYN2023-11-21
3520682053934815K232988Aplio 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
3520681268208444K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemJAK2024-04-02
3499131844748008K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5JAA2023-09-12
3520681844748008K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5JAA2023-09-12
3499131029157940K231748Cartesion Prime (PCD-1000A/3) V10.15KPS2023-09-12
3520681029157940K231748Cartesion Prime (PCD-1000A/3) V10.15KPS2023-09-12
3499131430262821K231281Aquilion Serve (TSX-307A/1) V1.3JAK2023-09-19
3520681430262821K231281Aquilion Serve (TSX-307A/1) V1.3JAK2023-09-19
3499131803361613K230355Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MRLNH2023-08-30
3520681803361613K230355Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MRLNH2023-08-30
3499131084591083K223336Vitrea Software Package, VSTP-002ALLZ2023-01-09
3520681084591083K223336Vitrea Software Package, VSTP-002ALLZ2023-01-09
3499132024271341K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0IYN2023-03-31
3520682024271341K223017Aplio 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
3520681904993780K222968Vantage 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
3520681599906414K222819Aquilion 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
3520681599204240K222387Vantage 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
3520681320309706K220986Aquilion Precision (TSX-304A/4) V10.10 with AiCEJAK2022-09-12
3499131420867368K220342XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3OWB2022-09-27
3520681420867368K220342XIDF-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
3520682065507875K220335Vantage 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
3520682066206735K220192Vantage 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
3520681381255651K213504Aquilion 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
3520681087576998K213305Vantage 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
3520681806855909K212960Aplio 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
3520681950802327K212333Aplio 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
3520681731727940K212056Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MRLNH2021-08-04
3499131798829541K211828Aquilion Exceed LBJAK2021-09-10
3520681798829541K211828Aquilion Exceed LBJAK2021-09-10
3499131858606656K211633Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MRLNH2021-07-22
3520681858606656K211633Vantage 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
3520681784590586K211037Vantage 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
3520681690882996K210900Alphenix, 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
3520681415760795K210340Vantage 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
3520681353713134K210164Vantage 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
3520681547472743K203553Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MRLNH2021-02-02
3499131691027044K203551Alphenix, INFX-8000V/B, /S, V9.1OWB2020-12-18
3520681691027044K203551Alphenix, INFX-8000V/B, /S, V9.1OWB2020-12-18
3499132027784797K203323Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MRLNH2021-03-04
3520682027784797K203323Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MRLNH2021-03-04
3499131326760836K203314Cartesion Prime (PCD-1000A/3) V10.8KPS2021-04-23
3520681326760836K203314Cartesion Prime (PCD-1000A/3) V10.8KPS2021-04-23
3499131320173715K203312Vitrea Software Package, VSTP-001ALLZ2021-02-16
3520681320173715K203312Vitrea Software Package, VSTP-001ALLZ2021-02-16
3499131278967911K203225Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging SystemJAK2021-03-24
3520681278967911K203225Aquilion 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
3520681780563392K203053Vantage 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
3520681516468076K203042Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-IJAK2020-12-10
3499131124062401K202767Vantage Orian 1.5T, MRT-1550, V6.0LNH2021-01-15
3520681124062401K202767Vantage Orian 1.5T, MRT-1550, V6.0LNH2021-01-15
3499131155306396K202364Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1IYN2020-10-15

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JAK1102026-05-20
LNH982026-03-27
IYN802026-01-20
OWB522026-03-10
LLZ182024-07-17
JAA162023-09-12
KPS142025-12-01
MOS122012-08-17
ITX82011-02-02
MQB62012-10-09
IYO62012-08-16
QIH22025-04-30
HKI12024-05-15
CFR12017-10-19