Company ยท JP
Toshibamedical Systems Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2018. Name variants (Inc, Corp, punctuation) are merged.
80510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 27 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 18 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 14 |
| OWB | Interventional Fluoroscopic X-Ray System | 13 |
| LLZ | System, Image Processing, Radiological | 3 |
| KPS | System, Tomography, Computed, Emission | 2 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 |
| IZI | System, X-Ray, Angiographic | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 20, 2018 | K173962 | Viamo c100 TUS-VC100 Diagnostic Ultrasound System Toshibamedical Systems Corporation, JP | IYN |
| Feb 23, 2018 | K173468 | Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 Toshibamedical Systems Corporation, JP | JAK |
| Jan 31, 2018 | K173088 | Vitrea Software Toshiba Package VSTP-001A Toshibamedical Systems Corporation, JP | LLZ |
| Jan 26, 2018 | K173382 | Vantage Galan 3T, V4.6 Toshibamedical Systems Corporation, JP | LNH |
| Jan 11, 2018 | K173090 | Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 Toshibamedical Systems Corporation, JP | IYN |
| Dec 14, 2017 | K172863 | Infinix-i, INFX-8000V, V7.0 Toshibamedical Systems Corporation, JP | OWB |
| Dec 12, 2017 | K172276 | Xario 200 Diagnostic Ultrasound System V6.0 Toshibamedical Systems Corporation, JP | IYN |
| Oct 30, 2017 | K172646 | XIDF-AWS801, Angio Workstation, V7.0 Toshibamedical Systems Corporation, JP | OWB |
| Jul 21, 2017 | K171597 | Vantage Elan 1.5T, V4.0 Toshibamedical Systems Corporation, JP | LNH |
| Jul 21, 2017 | K170832 | Ultimax-i, DREX-UI80 V1.60 Toshibamedical Systems Corporation, JP | OWB |
| Jun 30, 2017 | K170177 | Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 Toshibamedical Systems Corporation, JP | JAK |
| Jun 8, 2017 | K171222 | Vitrea Software Toshiba Package; VSTP-001A Toshibamedical Systems Corporation, JP | LLZ |
| Jun 7, 2017 | K170412 | Vantage Titan 1.5T, MRT-1510, M-Power GX Toshibamedical Systems Corporation, JP | LNH |
| Jun 1, 2017 | K170490 | Celesteion, PCA-9000A/3 Toshibamedical Systems Corporation, JP | KPS |
| May 30, 2017 | K163702 | Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1 Toshibamedical Systems Corporation, JP | IYN |
| Feb 2, 2017 | K170019 | Aquilion Lightning, TSX-036A/1, V8.4 Toshibamedical Systems Corporation, JP | JAK |
| Nov 25, 2016 | K162183 | Vantage Galan 3T, MRT-3020, V4.0 Toshibamedical Systems Corporation, JP | LNH |
| Nov 1, 2016 | K162155 | Xario 200 Diagnostic Ultrasound System V5.0 Toshibamedical Systems Corporation, JP | IYN |
| Oct 17, 2016 | K162614 | Infinix, INFX-8000V, V6.35 Toshibamedical Systems Corporation, JP | OWB |
| Sep 30, 2016 | K162187 | Xario 100 Diagnostic Ultrasound System, V5.0 Toshibamedical Systems Corporation, JP | IYN |
| Sep 21, 2016 | K161843 | Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0 Toshibamedical Systems Corporation, JP | IYN |
| Aug 23, 2016 | K160632 | Vantage Titan 1.5T, MRT-1510, V3.6 Software Toshibamedical Systems Corporation, JP | LNH |
| Jul 22, 2016 | K161009 | Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4 Toshibamedical Systems Corporation, JP | JAK |
| Jun 9, 2016 | K160587 | Aquilion ONE (TSX-305A/3) V7.3 Toshibamedical Systems Corporation, JP | JAK |
| Apr 1, 2016 | K153263 | Aquilion Lightning, TSX-035A/4 and /5, V7.0 Toshibamedical Systems Corporation, JP | JAK |
| Jan 15, 2016 | K152697 | INFX-8000C, V6.20 Toshibamedical Systems Corporation, JP | OWB |
| Jan 12, 2016 | K152696 | INFX-8000V, V6.20 Toshibamedical Systems Corporation, JP | OWB |
| Nov 27, 2015 | K151673 | Aquilion ONE Vision with FIRST 1.0 (CCRS-001A) Toshibamedical Systems Corporation, JP | JAK |
| Nov 25, 2015 | K152785 | XIDF-AWS801, Angio Workstation, V6.20 Toshibamedical Systems Corporation, JP | OWB |
| Oct 23, 2015 | K152371 | Vantage Titan 3T Toshibamedical Systems Corporation, JP | LNH |
| Oct 9, 2015 | K151833 | Aquilion Lightning (TSX-035A/2, V7.0) Toshibamedical Systems Corporation, JP | JAK |
| Jul 13, 2015 | K151091 | Vitrea Software Toshiba Package, VSTP-001A Toshibamedical Systems Corporation, JP | LLZ |
| Jul 9, 2015 | K151451 | Aplio 500/400/300 Diagnostic Ultrasound System V6.0 Toshibamedical Systems Corporation, JP | IYN |
| Jun 18, 2015 | K150967 | XIDF-AWS801, Angio Workstation, V6.10 Toshibamedical Systems Corporation, JP | OWB |
| May 15, 2015 | K143294 | Adaptive Motion Correction (AMC), CSMC-001A and 4D Airways Toshibamedical Systems Corporation, JP | JAK |
| Apr 17, 2015 | K150427 | Vantage Titan 1.5T, V3.1, MRT-1510 Toshibamedical Systems Corporation, JP | LNH |
| Apr 9, 2015 | K143008 | Vantage Titan 3T Toshibamedical Systems Corporation, JP | LNH |
| Mar 19, 2015 | K150003 | Aquilion LB, TSX-201A/3, V6.0 Toshibamedical Systems Corporation, JP | JAK |
| Mar 11, 2015 | K142736 | XIDF-AWS801, Angio Workstation, v5.31 Toshibamedical Systems Corporation, JP | OWB |
| Mar 10, 2015 | K142465 | Aquilion ONE Vision, v7.0 Toshibamedical Systems Corporation, JP | JAK |
| Jan 29, 2015 | K143281 | Ultimax-i Toshibamedical Systems Corporation, JP | OWB |
| Jan 12, 2015 | K143223 | CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT Toshibamedical Systems Corporation, JP | JAK |
| Jan 9, 2015 | K143225 | INFX-8000V with Wireless Footswitch Toshibamedical Systems Corporation, JP | OWB |
| Nov 26, 2014 | K141741 | AQUILION PRIME, V6.00 Toshibamedical Systems Corporation | JAK |
| Nov 20, 2014 | K143027 | Xario 200, V3.0 Toshibamedical Systems Corporation, JP | IYN |
| Nov 19, 2014 | K143046 | Xario 100, V3.0 Toshibamedical Systems Corporation, JP | IYN |
| Oct 28, 2014 | K141459 | APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM, V5.0 Toshibamedical Systems Corporation | IYN |
| Sep 8, 2014 | K141541 | XIDF-AWS801, ANGIO WORKSTATION, V5.31 Toshibamedical Systems Corporation | JAA |
| Sep 5, 2014 | K134025 | AQUILION ONE VISION SELF-PROPELLED SCAN BASE KIT FOR IVR-CT Toshibamedical Systems Corporation | JAK |
| Jul 23, 2014 | K133535 | INFX-8000V, V5.30 Toshibamedical Systems Corporation | OWB |
Newest 50 of 80.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||