Toshibamedical Systems Corporation
Tustin, CA, US
Toshibamedical Systems Corporation appears in FDA device records in Tustin, CA. FDA records list 80 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 80
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 80FDA records hold 80 510(k) clearances for Toshibamedical Systems Corporation between 2004 and 2018. The busiest year on record is 2015, with 16. The most recent is 2018, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 2 |
| 2006 | 2 |
| 2007 | 1 |
| 2009 | 2 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 8 |
| 2013 | 8 |
| 2014 | 12 |
| 2015 | 16 |
| 2016 | 11 |
| 2017 | 11 |
| 2018 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K173962 | Viamo c100 TUS-VC100 Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K173468 | Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 | JAK | Substantially Equivalent | |
| K173088 | Vitrea Software Toshiba Package VSTP-001A | LLZ | Substantially Equivalent | |
| K173382 | Vantage Galan 3T, V4.6 | LNH | Substantially Equivalent | |
| K173090 | Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 | IYN | Substantially Equivalent | |
| K172863 | Infinix-i, INFX-8000V, V7.0 | OWB | Substantially Equivalent | |
| K172276 | Xario 200 Diagnostic Ultrasound System V6.0 | IYN | Substantially Equivalent | |
| K172646 | XIDF-AWS801, Angio Workstation, V7.0 | OWB | Substantially Equivalent | |
| K171597 | Vantage Elan 1.5T, V4.0 | LNH | Substantially Equivalent | |
| K170832 | Ultimax-i, DREX-UI80 V1.60 | OWB | Substantially Equivalent | |
| K170177 | Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 | JAK | Substantially Equivalent | |
| K171222 | Vitrea Software Toshiba Package; VSTP-001A | LLZ | Substantially Equivalent | |
| K170412 | Vantage Titan 1.5T, MRT-1510, M-Power GX | LNH | Substantially Equivalent | |
| K170490 | Celesteion, PCA-9000A/3 | KPS | Substantially Equivalent | |
| K163702 | Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1 | IYN | Substantially Equivalent | |
| K170019 | Aquilion Lightning, TSX-036A/1, V8.4 | JAK | Substantially Equivalent | |
| K162183 | Vantage Galan 3T, MRT-3020, V4.0 | LNH | Substantially Equivalent | |
| K162155 | Xario 200 Diagnostic Ultrasound System V5.0 | IYN | Substantially Equivalent | |
| K162614 | Infinix, INFX-8000V, V6.35 | OWB | Substantially Equivalent | |
| K162187 | Xario 100 Diagnostic Ultrasound System, V5.0 | IYN | Substantially Equivalent | |
| K161843 | Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0 | IYN | Substantially Equivalent | |
| K160632 | Vantage Titan 1.5T, MRT-1510, V3.6 Software | LNH | Substantially Equivalent | |
| K161009 | Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4 | JAK | Substantially Equivalent | |
| K160587 | Aquilion ONE (TSX-305A/3) V7.3 | JAK | Substantially Equivalent | |
| K153263 | Aquilion Lightning, TSX-035A/4 and /5, V7.0 | JAK | Substantially Equivalent | |
| K152697 | INFX-8000C, V6.20 | OWB | Substantially Equivalent | |
| K152696 | INFX-8000V, V6.20 | OWB | Substantially Equivalent | |
| K151673 | Aquilion ONE Vision with FIRST 1.0 (CCRS-001A) | JAK | Substantially Equivalent | |
| K152785 | XIDF-AWS801, Angio Workstation, V6.20 | OWB | Substantially Equivalent | |
| K152371 | Vantage Titan 3T | LNH | Substantially Equivalent | |
| K151833 | Aquilion Lightning (TSX-035A/2, V7.0) | JAK | Substantially Equivalent | |
| K151091 | Vitrea Software Toshiba Package, VSTP-001A | LLZ | Substantially Equivalent | |
| K151451 | Aplio 500/400/300 Diagnostic Ultrasound System V6.0 | IYN | Substantially Equivalent | |
| K150967 | XIDF-AWS801, Angio Workstation, V6.10 | OWB | Substantially Equivalent | |
| K143294 | Adaptive Motion Correction (AMC), CSMC-001A and 4D Airways | JAK | Substantially Equivalent | |
| K150427 | Vantage Titan 1.5T, V3.1, MRT-1510 | LNH | Substantially Equivalent | |
| K143008 | Vantage Titan 3T | LNH | Substantially Equivalent | |
| K150003 | Aquilion LB, TSX-201A/3, V6.0 | JAK | Substantially Equivalent | |
| K142736 | XIDF-AWS801, Angio Workstation, v5.31 | OWB | Substantially Equivalent | |
| K142465 | Aquilion ONE Vision, v7.0 | JAK | Substantially Equivalent | |
| K143281 | Ultimax-i | OWB | Substantially Equivalent | |
| K143223 | CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT | JAK | Substantially Equivalent | |
| K143225 | INFX-8000V with Wireless Footswitch | OWB | Substantially Equivalent | |
| K141741 | AQUILION PRIME, V6.00 | JAK | Substantially Equivalent | |
| K143027 | Xario 200, V3.0 | IYN | Substantially Equivalent | |
| K143046 | Xario 100, V3.0 | IYN | Substantially Equivalent | |
| K141459 | APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM, V5.0 | IYN | Substantially Equivalent | |
| K141541 | XIDF-AWS801, ANGIO WORKSTATION, V5.31 | JAA | Substantially Equivalent | |
| K134025 | AQUILION ONE VISION SELF-PROPELLED SCAN BASE KIT FOR IVR-CT | JAK | Substantially Equivalent | |
| K133535 | INFX-8000V, V5.30 | OWB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- OWBInterventional Fluoroscopic X-Ray System
- LLZSystem, Image Processing, Radiological
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- LNHSystem, Nuclear Magnetic Resonance Imaging
- KPSSystem, Tomography, Computed, Emission
- IZISystem, X-Ray, Angiographic
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- JAKSystem, X-Ray, Tomography, Computed
- ITXTransducer, Ultrasonic, Diagnostic
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain