# Toshibamedical Systems Corporation

- Location (FDA's records): Otawara-Shi, JP
- FDA decisions: 80 (2004–2018): 80 510(k) clearances
- Product codes: JAK (27), IYN (18), LNH (14), OWB (13), LLZ (3), KPS (2), IZI (1), ITX (1), JAA (1)
- 510(k) review time since 2016: median 104 days, against 98 for FDA's reviews in the same codes and years (9 of 27 faster)
- Predicates its devices cite: 126 (62 its own); citations of its devices by later devices: 113 (62 its own)
- Recalls linked to its devices: 49 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Toshiba America Medical Systems, In.C: 26 (https://510kreport.com/company/toshiba-america-medical-systems-in-c)
- GE Healthcare: 8 (https://510kreport.com/company/ge-healthcare)
- GE Medical Systems: 4 (https://510kreport.com/company/ge-medical-systems)
- Siemens Medical Solutions USA, Inc.: 3 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Sonosite,Inc.: 3 (https://510kreport.com/company/sonosite)
- Toshiba Medical Systems Coporation, Japan: 2 (https://510kreport.com/company/toshiba-medical-systems-coporation-japan)
- Vital Images, Inc.: 2 (https://510kreport.com/company/vital-images)
- Siemens AG Medical Solutions: 2 (https://510kreport.com/company/siemens-ag-medical-solutions)

## Firms that cite its devices most
- Canon Medical Systems Corporation: 23 (https://510kreport.com/company/canon-medical-systems)
- Toshiba America Medical Systems, In.C: 10 (https://510kreport.com/company/toshiba-america-medical-systems-in-c)
- Vital Images, Inc.: 3 (https://510kreport.com/company/vital-images)
- Toshiba Medical Systems Corporation, Japan: 3 (https://510kreport.com/company/toshiba-medical-systems-japan)
- Supersonic Imagine: 3 (https://510kreport.com/company/supersonic-imagine)
- Toshiba Medical Systems Coroporation: 3 (https://510kreport.com/company/toshiba-medical-systems-coroporation)
- Delphinus Medical Technologies: 1 (https://510kreport.com/company/delphinus-medical-technologies)
- Qi Imaging, LLC: 1 (https://510kreport.com/company/qi-imaging)

## Its most-cited devices
- K151091: Vitrea Software Toshiba Package, VSTP-001A (2015), cited by 4
- K141741: Aquilion Prime, V6.00 (2014), cited by 4
- K120638: Vantage Titan (2012), cited by 3
- K132222: Aquilion One Vision, V6.0 (2013), cited by 3
- K143008: Vantage Titan 3T (2015), cited by 3
- K162183: Vantage Galan 3T, MRT-3020, V4.0 (2016), cited by 3

## Recent decisions
- K173962: Viamo c100 TUS-VC100 Diagnostic Ultrasound System (Apr 20, 2018)
- K173468: Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 (Feb 23, 2018)
- K173088: Vitrea Software Toshiba Package VSTP-001A (Jan 31, 2018)
- K173382: Vantage Galan 3T, V4.6 (Jan 26, 2018)
- K173090: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 (Jan 11, 2018)
- K172863: Infinix-i, INFX-8000V, V7.0 (Dec 14, 2017)
- K172276: Xario 200 Diagnostic Ultrasound System V6.0 (Dec 12, 2017)
- K172646: XIDF-AWS801, Angio Workstation, V7.0 (Oct 30, 2017)

Source page: https://510kreport.com/company/toshibamedical-systems