| 2026-05-20 |
K253596 |
Aquilion ONE (TSX-308A/TSX-306A) V2.0 |
JAK |
Class II |
Radiology |
| 2026-03-27 |
K253625 |
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR |
LNH |
— |
— |
| 2026-03-13 |
K260078 |
Aquilion ServeSP (TSX-307B) V2.0 |
JAK |
Class II |
Radiology |
| 2026-03-10 |
K253584 |
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) |
OWB |
— |
— |
| 2026-01-20 |
K253597 |
Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System |
IYN |
Class II |
Radiology |
| 2025-12-01 |
K251370 |
Cartesion Prime (PCD-1000A/3) V10.21 |
KPS |
Class II |
Radiology |
| 2025-10-31 |
K252074 |
Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System |
IYN |
Class II |
Radiology |
| 2025-10-10 |
K251602 |
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging |
OWB |
— |
— |
| 2025-09-26 |
K251645 |
Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP |
JAK |
Class II |
Radiology |
| 2025-07-22 |
K250901 |
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR |
LNH |
— |
— |
| 2025-06-20 |
K243398 |
CT Scanner TSX-501R/1 V11.1 |
JAK |
Class II |
Radiology |
| 2025-05-13 |
K242808 |
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5 |
IYN |
Class II |
Radiology |
| 2025-04-30 |
K250328 |
UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program |
QIH |
Class II |
Radiology |
| 2025-01-07 |
K243335 |
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR |
LNH |
— |
— |
| 2024-12-23 |
K242403 |
Aquilion ONE (TSX-308A/3) V1.5 |
JAK |
Class II |
Radiology |
| 2024-09-12 |
K241582 |
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700) |
IYN |
Class II |
Radiology |
| 2024-08-30 |
K233107 |
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5 |
OWB |
— |
— |
| 2024-08-20 |
K241496 |
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR |
LNH |
— |
— |
| 2024-07-17 |
K240705 |
Vitrea Software Package, VSTP-002A V2.0 |
LLZ |
Class II |
Radiology |
| 2024-04-12 |
K240238 |
Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR |
LNH |
— |
— |
| 2024-04-02 |
K232835 |
Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System |
JAK |
Class II |
Radiology |
| 2024-01-24 |
K233195 |
Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System |
IYN |
Class II |
Radiology |
| 2023-12-06 |
K233334 |
Aquilion Serve SP (TSX-307B/1) V1.3 |
JAK |
Class II |
Radiology |
| 2023-11-21 |
K232988 |
Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System |
IYN |
Class II |
Radiology |
| 2023-09-19 |
K231281 |
Aquilion Serve (TSX-307A/1) V1.3 |
JAK |
Class II |
Radiology |
| 2023-09-12 |
K232526 |
XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 |
JAA |
Class II |
Radiology |
| 2023-09-12 |
K231748 |
Cartesion Prime (PCD-1000A/3) V10.15 |
KPS |
Class II |
Radiology |
| 2023-08-30 |
K230355 |
Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR |
LNH |
— |
— |
| 2023-03-31 |
K223017 |
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 |
IYN |
Class II |
Radiology |
| 2023-03-07 |
K223726 |
Aquilion Precision (TSX-304A/4) V10.14 with AiCE |
JAK |
Class II |
Radiology |
| 2023-03-03 |
K222819 |
Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i |
JAK |
Class II |
Radiology |
| 2023-01-09 |
K223336 |
Vitrea Software Package, VSTP-002A |
LLZ |
Class II |
Radiology |
| 2022-10-25 |
K222968 |
Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR |
LNH |
— |
— |
| 2022-09-27 |
K220342 |
XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3 |
OWB |
— |
— |
| 2022-09-12 |
K220986 |
Aquilion Precision (TSX-304A/4) V10.10 with AiCE |
JAK |
Class II |
Radiology |
| 2022-08-31 |
K222387 |
Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR |
LNH |
— |
— |
| 2022-06-16 |
K213504 |
Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A |
JAK |
Class II |
Radiology |
| 2022-04-08 |
K220192 |
Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR |
LNH |
— |
— |
| 2022-04-05 |
K220335 |
Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR |
LNH |
— |
— |
| 2022-03-22 |
K212960 |
Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 |
IYN |
Class II |
Radiology |
| 2022-03-03 |
K220018 |
MR Elastography; MZEK-001A |
LNH |
— |
— |
| 2022-01-24 |
K212333 |
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 |
IYN |
Class II |
Radiology |
| 2021-12-01 |
K213305 |
Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR |
LNH |
— |
— |
| 2021-09-10 |
K211828 |
Aquilion Exceed LB |
JAK |
Class II |
Radiology |
| 2021-08-04 |
K212056 |
Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR |
LNH |
— |
— |
| 2021-07-22 |
K211633 |
Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR |
LNH |
— |
— |
| 2021-05-17 |
K211037 |
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR |
LNH |
— |
— |
| 2021-04-23 |
K203314 |
Cartesion Prime (PCD-1000A/3) V10.8 |
KPS |
Class II |
Radiology |
| 2021-04-12 |
K210900 |
Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2 |
OWB |
— |
— |
| 2021-04-01 |
K210340 |
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR |
LNH |
— |
— |
| 2021-03-24 |
K203225 |
Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System |
JAK |
Class II |
Radiology |
| 2021-03-10 |
K210164 |
Vantage Elan 1.5T, MRT-2020, V6.0 |
LNH |
— |
— |
| 2021-03-04 |
K203323 |
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR |
LNH |
— |
— |
| 2021-02-16 |
K203312 |
Vitrea Software Package, VSTP-001A |
LLZ |
Class II |
Radiology |
| 2021-02-02 |
K203553 |
Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR |
LNH |
— |
— |
| 2021-01-15 |
K202767 |
Vantage Orian 1.5T, MRT-1550, V6.0 |
LNH |
— |
— |
| 2021-01-12 |
K201836 |
Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i |
JAK |
Class II |
Radiology |
| 2020-12-18 |
K203551 |
Alphenix, INFX-8000V/B, /S, V9.1 |
OWB |
— |
— |
| 2020-12-10 |
K203042 |
Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I |
JAK |
Class II |
Radiology |
| 2020-12-02 |
K203053 |
Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR |
LNH |
— |
— |
| 2020-10-16 |
K202737 |
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Xario200G and Xario100G, Diagnostic Ultrasound System |
IYN |
Class II |
Radiology |
| 2020-10-15 |
K202364 |
Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1 |
IYN |
Class II |
Radiology |
| 2020-10-15 |
K202349 |
Cartesion Prime, PCD-1000A, V10.7 |
KPS |
Class II |
Radiology |
| 2020-10-08 |
K201972 |
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1 |
IYN |
Class II |
Radiology |
| 2020-09-22 |
K202210 |
Vantage Orian 1.5T, MRT-1550, V6.0 |
LNH |
— |
— |
| 2020-07-14 |
K193097 |
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR |
LNH |
— |
— |
| 2020-06-03 |
K193021 |
Vantage Orian 1.5T, MRT-1550, V6.0 |
LNH |
— |
— |
| 2020-03-09 |
K192574 |
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR |
LNH |
— |
— |
| 2020-03-02 |
K192506 |
Vantage Galan 3T, MRT-3020, V6.0 |
LNH |
— |
— |
| 2020-02-21 |
K192832 |
Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i |
JAK |
Class II |
Radiology |
| 2020-02-14 |
K192923 |
Vitrea Software Package |
LLZ |
Class II |
Radiology |
| 2020-02-13 |
K192828 |
Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System |
JAK |
Class II |
Radiology |