Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Toshibamedical Systems Corporation · Predicate Candidate Screening
80 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
92 daysmedian FDA review time
170 days90th percentile
80clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K173962 | Viamo c100 TUS-VC100 Diagnostic Ultrasound System | Toshibamedical Systems Corporation | 2018-04-20 | 113 | 0 |
| K173468 | Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 | Toshibamedical Systems Corporation | 2018-02-23 | 107 | 1 |
| K173088 | Vitrea Software Toshiba Package VSTP-001A | Toshibamedical Systems Corporation | 2018-01-31 | 124 | 0 |
| K173382 | Vantage Galan 3T, V4.6 | Toshibamedical Systems Corporation | 2018-01-26 | 88 | 0 |
| K173090 | Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 | Toshibamedical Systems Corporation | 2018-01-11 | 104 | 0 |
| K172863 | Infinix-i, INFX-8000V, V7.0 | Toshibamedical Systems Corporation | 2017-12-14 | 85 | 0 |
| K172276 | Xario 200 Diagnostic Ultrasound System V6.0 | Toshibamedical Systems Corporation | 2017-12-12 | 137 | 0 |
| K172646 | XIDF-AWS801, Angio Workstation, V7.0 | Toshibamedical Systems Corporation | 2017-10-30 | 59 | 0 |
| K171597 | Vantage Elan 1.5T, V4.0 | Toshibamedical Systems Corporation | 2017-07-21 | 51 | 0 |
| K170832 | Ultimax-i, DREX-UI80 V1.60 | Toshibamedical Systems Corporation | 2017-07-21 | 123 | 0 |
| K170177 | Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 | Toshibamedical Systems Corporation | 2017-06-30 | 162 | 1 |
| K171222 | Vitrea Software Toshiba Package; VSTP-001A | Toshibamedical Systems Corporation | 2017-06-08 | 43 | 0 |
| K170412 | Vantage Titan 1.5T, MRT-1510, M-Power GX | Toshibamedical Systems Corporation | 2017-06-07 | 117 | 0 |
| K170490 | Celesteion, PCA-9000A/3 | Toshibamedical Systems Corporation | 2017-06-01 | 104 | 0 |
| K163702 | Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1 | Toshibamedical Systems Corporation | 2017-05-30 | 152 | 0 |
| K170019 | Aquilion Lightning, TSX-036A/1, V8.4 | Toshibamedical Systems Corporation | 2017-02-02 | 30 | 1 |
| K162183 | Vantage Galan 3T, MRT-3020, V4.0 | Toshibamedical Systems Corporation | 2016-11-25 | 113 | 0 |
| K162155 | Xario 200 Diagnostic Ultrasound System V5.0 | Toshibamedical Systems Corporation | 2016-11-01 | 91 | 0 |
| K162614 | Infinix, INFX-8000V, V6.35 | Toshibamedical Systems Corporation | 2016-10-17 | 28 | 0 |
| K162187 | Xario 100 Diagnostic Ultrasound System, V5.0 | Toshibamedical Systems Corporation | 2016-09-30 | 57 | 0 |
| K161843 | Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0 | Toshibamedical Systems Corporation | 2016-09-21 | 78 | 0 |
| K160632 | Vantage Titan 1.5T, MRT-1510, V3.6 Software | Toshibamedical Systems Corporation | 2016-08-23 | 169 | 0 |
| K161009 | Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4 | Toshibamedical Systems Corporation | 2016-07-22 | 102 | 0 |
| K160587 | Aquilion ONE (TSX-305A/3) V7.3 | Toshibamedical Systems Corporation | 2016-06-09 | 100 | 0 |
| K153263 | Aquilion Lightning, TSX-035A/4 and /5, V7.0 | Toshibamedical Systems Corporation | 2016-04-01 | 143 | 0 |
| K152697 | INFX-8000C, V6.20 | Toshibamedical Systems Corporation | 2016-01-15 | 116 | 0 |
| K152696 | INFX-8000V, V6.20 | Toshibamedical Systems Corporation | 2016-01-12 | 113 | 1 |
| K151673 | Aquilion ONE Vision with FIRST 1.0 (CCRS-001A) | Toshibamedical Systems Corporation | 2015-11-27 | 158 | 1 |
| K152785 | XIDF-AWS801, Angio Workstation, V6.20 | Toshibamedical Systems Corporation | 2015-11-25 | 61 | 0 |
| K152371 | Vantage Titan 3T | Toshibamedical Systems Corporation | 2015-10-23 | 63 | 1 |
| K151833 | Aquilion Lightning (TSX-035A/2, V7.0) | Toshibamedical Systems Corporation | 2015-10-09 | 95 | 0 |
| K151091 | Vitrea Software Toshiba Package, VSTP-001A | Toshibamedical Systems Corporation | 2015-07-13 | 81 | 0 |
| K151451 | Aplio 500/400/300 Diagnostic Ultrasound System V6.0 | Toshibamedical Systems Corporation | 2015-07-09 | 41 | 0 |
| K150967 | XIDF-AWS801, Angio Workstation, V6.10 | Toshibamedical Systems Corporation | 2015-06-18 | 66 | 1 |
| K143294 | Adaptive Motion Correction (AMC), CSMC-001A and 4D Airways | Toshibamedical Systems Corporation | 2015-05-15 | 179 | 0 |
| K150427 | Vantage Titan 1.5T, V3.1, MRT-1510 | Toshibamedical Systems Corporation | 2015-04-17 | 57 | 0 |
| K143008 | Vantage Titan 3T | Toshibamedical Systems Corporation | 2015-04-09 | 171 | 0 |
| K150003 | Aquilion LB, TSX-201A/3, V6.0 | Toshibamedical Systems Corporation | 2015-03-19 | 76 | 0 |
| K142736 | XIDF-AWS801, Angio Workstation, v5.31 | Toshibamedical Systems Corporation | 2015-03-11 | 169 | 0 |
| K142465 | Aquilion ONE Vision, v7.0 | Toshibamedical Systems Corporation | 2015-03-10 | 189 | 1 |
| K143281 | Ultimax-i | Toshibamedical Systems Corporation | 2015-01-29 | 76 | 0 |
| K143223 | CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for I | Toshibamedical Systems Corporation | 2015-01-12 | 63 | 0 |
| K143225 | INFX-8000V with Wireless Footswitch | Toshibamedical Systems Corporation | 2015-01-09 | 60 | 2 |
| K141741 | AQUILION PRIME, V6.00 | Toshibamedical Systems Corporation | 2014-11-26 | 152 | 2 |
| K143027 | Xario 200, V3.0 | Toshibamedical Systems Corporation | 2014-11-20 | 30 | 0 |
| K143046 | Xario 100, V3.0 | Toshibamedical Systems Corporation | 2014-11-19 | 28 | 0 |
| K141459 | APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM, V5.0 | Toshibamedical Systems Corporation | 2014-10-28 | 148 | 0 |
| K141541 | XIDF-AWS801, ANGIO WORKSTATION, V5.31 | Toshibamedical Systems Corporation | 2014-09-08 | 90 | 0 |
| K134025 | AQUILION ONE VISION SELF-PROPELLED SCAN BASE KIT FOR IVR-CT | Toshibamedical Systems Corporation | 2014-09-05 | 249 | 0 |
| K133535 | INFX-8000V, V5.30 | Toshibamedical Systems Corporation | 2014-07-23 | 247 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda