Data / Medical devices / Japan / Canon Inc.

Canon Inc.: FDA-registered device maker in OTAWARA-SHI Tochigi, Japan, 211 510(k) clearances

Name: Canon Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Canon Inc. is registered with the FDA (registration 9614698) in OTAWARA-SHI Tochigi, Japan. It lists 22 device types. The FDA files 211 510(k) clearances under its listings, the newest dated May 20, 2026. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Canon Inc.

FDA registration number: 9614698
FEI number: 3002808382
Address: 1385, Shimoishigami, OTAWARA-SHI Tochigi, Japan, 324-8550
Owner or operator: CANON INC. (8030410)
Roles: Contract manufacturer, Manufacturer
First device listed: July 12, 2023
Registered through: 2027
Brand names listed: APLIO A550, APLIO A450, AND APLIO A, DIAGNOSTIC ULTRASOUND SYSTEM, SOFTWARE V6.5, APLIO A550, APLIO A450, APLIO A, DIAGNOSTIC ULTRASOUND SYSTEM, SOFTWARE V5.1, APLIO I900/I800/I700 DIAGNOSTIC ULTRASOUND SYSTEM, SOFTWARE V7 (TUS-AI900, TUS-AI800, TUS-AI700), AQUILION LIGHTNING (TSX-035A/2, V7), AQUILION LIGHTNING (TSX-036A/7) V10.2 WITH AICE-I, AQUILION ONE (TSX-301C), AQUILION ONE (TSX-305A/3) V8.3 WITH FIRST 2.1, AQUILION ONE (TSX-306A/3) V10 WITH SPECTRAL IMAGING SYSTEM and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Contract manufacturer	accessdata.fda.gov
Automated Radiological Image Processing Software	QIH	2	Manufacturer	accessdata.fda.gov
Coil, Magnetic Resonance, Specialty	MOS	2	Manufacturer	accessdata.fda.gov
Collimator, Dermatological, Therapeutic X-Ray	IYL	2	Manufacturer	accessdata.fda.gov
Continuous Glucose Monitor, Implanted, Adjunctive Use	QCD	3	Manufacturer	accessdata.fda.gov
Electrode, Ion Specific, Potassium	CEM	2	Contract manufacturer	accessdata.fda.gov
Electrode, Ion Specific, Sodium	JGS	2	Contract manufacturer	accessdata.fda.gov
Electrode, Ion-Specific, Chloride	CGZ	2	Contract manufacturer	accessdata.fda.gov
Hexokinase, Glucose	CFR	2	Contract manufacturer	accessdata.fda.gov
Interventional Fluoroscopic X-Ray System	OWB	2	Manufacturer	accessdata.fda.gov
Sensor, Glucose, Implanted, Non-Adjunctive Use	QHJ	3	Manufacturer	accessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)	MQB	2	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
System, Nuclear Magnetic Resonance Imaging	LNH	2	Manufacturer	accessdata.fda.gov
System, Test, Human Chorionic Gonadotropin	DHA	2	Contract manufacturer	accessdata.fda.gov
System, Tomography, Computed, Emission	KPS	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Angiographic	IZI	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Contract manufacturer, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 211.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 20, 2026	K253596	Aquilion ONE (TSX-308A/TSX-306A) V2.0	JAK	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
March 27, 2026	K253625	Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR	LNH	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
March 13, 2026	K260078	Aquilion ServeSP (TSX-307B) V2.0	JAK	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
March 10, 2026	K253584	Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)	OWB	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
January 20, 2026	K253597	Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
December 1, 2025	K251370	Cartesion Prime (PCD-1000A/3) V10.21	KPS	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
October 31, 2025	K252074	Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
October 10, 2025	K251602	Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging	OWB	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
September 26, 2025	K251645	Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP	JAK	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
July 22, 2025	K250901	Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR	LNH	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
June 20, 2025	K243398	CT Scanner TSX-501R/1 V11.1	JAK	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
May 13, 2025	K242808	Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5	IYN	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
April 30, 2025	K250328	UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program	QIH	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
January 7, 2025	K243335	Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR	LNH	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
December 23, 2024	K242403	Aquilion ONE (TSX-308A/3) V1.5	JAK	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
September 12, 2024	K241582	Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)	IYN	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
August 30, 2024	K233107	Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5	OWB	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
August 20, 2024	K241496	Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR	LNH	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
July 17, 2024	K240705	Vitrea Software Package, VSTP-002A V2.0	LLZ	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
April 12, 2024	K240238	Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR	LNH	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
April 2, 2024	K232835	Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System	JAK	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
January 24, 2024	K233195	Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
December 6, 2023	K233334	Aquilion Serve SP (TSX-307B/1) V1.3	JAK	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
November 21, 2023	K232988	Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
September 19, 2023	K231281	Aquilion Serve (TSX-307A/1) V1.3	JAK	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
September 12, 2023	K232526	XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5	JAA	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
September 12, 2023	K231748	Cartesion Prime (PCD-1000A/3) V10.15	KPS	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
August 30, 2023	K230355	Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR	LNH	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
March 31, 2023	K223017	Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0	IYN	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
March 3, 2023	K222819	Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i	JAK	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
January 9, 2023	K223336	Vitrea Software Package, VSTP-002A	LLZ	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
October 25, 2022	K222968	Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR	LNH	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
September 27, 2022	K220342	XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3	OWB	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
September 12, 2022	K220986	Aquilion Precision (TSX-304A/4) V10.10 with AiCE	JAK	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
August 31, 2022	K222387	Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR	LNH	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
June 16, 2022	K213504	Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A	JAK	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
April 8, 2022	K220192	Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR	LNH	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
April 5, 2022	K220335	Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR	LNH	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
March 22, 2022	K212960	Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5	IYN	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
January 24, 2022	K212333	Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5	IYN	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
December 1, 2021	K213305	Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR	LNH	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
September 10, 2021	K211828	Aquilion Exceed LB	JAK	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
August 4, 2021	K212056	Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR	LNH	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
July 22, 2021	K211633	Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR	LNH	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
May 17, 2021	K211037	Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR	LNH	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
April 23, 2021	K203314	Cartesion Prime (PCD-1000A/3) V10.8	KPS	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
April 12, 2021	K210900	Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2	OWB	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
April 1, 2021	K210340	Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR	LNH	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
March 24, 2021	K203225	Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System	JAK	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
March 10, 2021	K210164	Vantage Elan 1.5T, MRT-2020, V6.0	LNH	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
March 4, 2021	K203323	Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR	LNH	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
February 16, 2021	K203312	Vitrea Software Package, VSTP-001A	LLZ	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
February 2, 2021	K203553	Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR	LNH	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
January 15, 2021	K202767	Vantage Orian 1.5T, MRT-1550, V6.0	LNH	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
January 12, 2021	K201836	Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i	JAK	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
December 18, 2020	K203551	Alphenix, INFX-8000V/B, /S, V9.1	OWB	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
December 10, 2020	K203042	Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I	JAK	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
December 2, 2020	K203053	Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR	LNH	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
October 15, 2020	K202364	Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1	IYN	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
October 15, 2020	K202349	Cartesion Prime, PCD-1000A, V10.7	KPS	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
October 8, 2020	K201972	Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1	IYN	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
September 22, 2020	K202210	Vantage Orian 1.5T, MRT-1550, V6.0	LNH	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
July 14, 2020	K193097	Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR	LNH	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
June 3, 2020	K193021	Vantage Orian 1.5T, MRT-1550, V6.0	LNH	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
March 9, 2020	K192574	Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR	LNH	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
March 2, 2020	K192506	Vantage Galan 3T, MRT-3020, V6.0	LNH	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
February 21, 2020	K192832	Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i	JAK	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
February 13, 2020	K192828	Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System	JAK	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
September 18, 2019	K191663	Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0	IYN	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
September 6, 2019	K192188	Aquilion ONE (TSX-306A/3) V10.0	JAK	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
August 13, 2019	K191582	Cartesion Prime	KPS	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
July 23, 2019	K191662	Vantage Orian 1.5T, MRT-1550, V4.5	LNH	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
July 19, 2019	K191467	Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0	IYN	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
July 5, 2019	K182901	Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE	JAK	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
June 26, 2019	K191128	Vantage Titan 3T, MRT-3010, V2.5	LNH	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
June 12, 2019	K183046	Aquilion ONE (TSX-305A/6) V8.9 with AiCE	JAK	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
March 15, 2019	K183657	Vantage Galan 3T, MRT-3020/A9, V5.0	LNH	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
November 16, 2018	K181646	Celesteion, PCA-9000A/3, V6.5	JAK	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
November 2, 2018	K182596	Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
November 2, 2018	K182427	Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
October 31, 2018	K182679	Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1	IYN	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
October 19, 2018	K182282	Vantage Orian 1.5T, MRT-1550, V4.5	LNH	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
October 17, 2018	K182546	Alphenix, INFX-8000H/B, V8.0	OWB	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
September 28, 2018	K182415	Alphenix, INFX-8000F/B, V8.0	OWB	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
September 14, 2018	K182223	Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A	JAK	Substantially Equivalent	Canon Medical Systems, USA	accessdata.fda.gov
September 10, 2018	K181415	XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0	OWB	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
August 13, 2018	K181593	Vantage Galan 3T, MRT-3020/A7, V5.0	LNH	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
August 2, 2018	K181804	Alphenix, INFX-8000C/B, V8.0	OWB	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
July 25, 2018	K181670	Alphenix, INFX-8000V/B, V8.0	OWB	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
July 19, 2018	K181834	Ultimax-i, DREX-UI80 (V1.60)	OWB	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
April 20, 2018	K173962	Viamo c100 TUS-VC100 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Toshibamedical Systems Corporation	accessdata.fda.gov
February 23, 2018	K173468	Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0	JAK	Substantially Equivalent	Toshibamedical Systems Corporation	accessdata.fda.gov
January 26, 2018	K173382	Vantage Galan 3T, V4.6	LNH	Substantially Equivalent	Toshibamedical Systems Corporation	accessdata.fda.gov
January 11, 2018	K173090	Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4	IYN	Substantially Equivalent	Toshibamedical Systems Corporation	accessdata.fda.gov
December 14, 2017	K172863	Infinix-i, INFX-8000V, V7.0	OWB	Substantially Equivalent	Toshibamedical Systems Corporation	accessdata.fda.gov
December 12, 2017	K172276	Xario 200 Diagnostic Ultrasound System V6.0	IYN	Substantially Equivalent	Toshibamedical Systems Corporation	accessdata.fda.gov
November 17, 2017	K172878	Vantage Titan 3T, MRT-3010/A7, M-Power GX	LNH	Substantially Equivalent	Toshiba Medical Systems Corporation, Japan	accessdata.fda.gov
October 30, 2017	K172646	XIDF-AWS801, Angio Workstation, V7.0	OWB	Substantially Equivalent	Toshibamedical Systems Corporation	accessdata.fda.gov
October 6, 2017	K172188	Aquilion Prime SP, TSX-303B/1, v8.4	JAK	Substantially Equivalent	Toshiba Medical Systems Coroporation	accessdata.fda.gov
July 21, 2017	K171597	Vantage Elan 1.5T, V4.0	LNH	Substantially Equivalent	Toshibamedical Systems Corporation	accessdata.fda.gov

Compare with other makers

Updated May 20, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.