Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Toshiba America Medical Systems, In.C · Predicate Candidate Screening
146 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
49 daysmedian FDA review time
206 days90th percentile
146clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K141472 | VANTAGE ELAN | Toshiba America Medical Systems, In.C | 2014-09-19 | 108 | 0 |
| K133553 | KALARE | Toshiba America Medical Systems, In.C | 2014-06-13 | 206 | 1 |
| K140729 | APLIO ARTIDA, V3.2 | Toshiba America Medical Systems, In.C | 2014-05-23 | 60 | 0 |
| K132106 | INFINIX ANGIO WORKSTATION W/DTS SOFTWARE | Toshiba America Medical Systems, In.C | 2013-11-12 | 127 | 0 |
| K131822 | ULTRAEXTEND USWS-900A V2.1 AND V3.1 | Toshiba America Medical Systems, In.C | 2013-07-23 | 33 | 0 |
| K123097 | DOSE TRACKING SYSTEM MODEL XIDF-DTS801 | Toshiba America Medical Systems, In.C | 2013-02-13 | 134 | 0 |
| K122613 | VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US | Toshiba America Medical Systems, In.C | 2012-12-13 | 108 | 2 |
| K121076 | ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE | Toshiba America Medical Systems, In.C | 2012-10-09 | 183 | 0 |
| K122842 | RADREX-I, SW V4.00 MODEL DRAD-3000E | Toshiba America Medical Systems, In.C | 2012-10-09 | 22 | 0 |
| K122109 | AQUILION ONE VISION, V4.90 | Toshiba America Medical Systems, In.C | 2012-09-21 | 66 | 1 |
| K112989 | AQUILION CXL | Toshiba America Medical Systems, In.C | 2012-04-10 | 187 | 0 |
| K110066 | AQUILION PRIME | Toshiba America Medical Systems, In.C | 2012-01-26 | 381 | 0 |
| K113052 | INFINIX-CCI | Toshiba America Medical Systems, In.C | 2011-11-22 | 40 | 1 |
| K110870 | APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASO | Toshiba America Medical Systems, In.C | 2011-10-04 | 189 | 0 |
| K111633 | AQUILION LB MOVEMENT BASE KIT | Toshiba America Medical Systems, In.C | 2011-08-25 | 73 | 0 |
| K103629 | PET-512MC TRANSESOPHAGEAL TRANSDUCER | Toshiba America Medical Systems, In.C | 2011-02-02 | 51 | 0 |
| K101868 | INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V | Toshiba America Medical Systems, In.C | 2010-09-07 | 67 | 0 |
| K100067 | MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM | Toshiba America Medical Systems, In.C | 2010-01-28 | 17 | 0 |
| K093171 | VIAMO SSA-640A VERSION 1.2 | Toshiba America Medical Systems, In.C | 2009-12-04 | 57 | 0 |
| K092948 | APLIO MX SSA-780A, VERSION 1.0 | Toshiba America Medical Systems, In.C | 2009-10-09 | 15 | 1 |
| K092179 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERS | Toshiba America Medical Systems, In.C | 2009-07-29 | 8 | 1 |
| K091295 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION | Toshiba America Medical Systems, In.C | 2009-05-15 | 11 | 2 |
| K083503 | DRAD30003/RADREX-I | Toshiba America Medical Systems, In.C | 2009-02-13 | 79 | 1 |
| K090158 | APLIO ARTIDA V2.0 SSH-880CV | Toshiba America Medical Systems, In.C | 2009-02-06 | 15 | 5 |
| K083282 | MODEL TSX-301B AQUILION CT SYSTEM | Toshiba America Medical Systems, In.C | 2008-12-12 | 35 | 8 |
| K083014 | ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A | Toshiba America Medical Systems, In.C | 2008-10-17 | 8 | 0 |
| K082684 | 4D VIEWER RADIOLOGY, MODEL USWP-100A | Toshiba America Medical Systems, In.C | 2008-10-14 | 29 | 0 |
| K082830 | INFX-8000H, INFINIX-I | Toshiba America Medical Systems, In.C | 2008-10-10 | 14 | 1 |
| K082596 | ULTRAEXTEND USWS-900A | Toshiba America Medical Systems, In.C | 2008-09-23 | 15 | 0 |
| K082494 | DRAD3000E/RADREX-I | Toshiba America Medical Systems, In.C | 2008-09-12 | 14 | 0 |
| K082244 | PCA-8000A, MARK 11, PET / CT SYSTEM | Toshiba America Medical Systems, In.C | 2008-08-21 | 13 | 0 |
| K082119 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERS | Toshiba America Medical Systems, In.C | 2008-08-12 | 15 | 0 |
| K081621 | INFX-8000C (INFINIX CC-I AND VC-I) | Toshiba America Medical Systems, In.C | 2008-06-23 | 14 | 1 |
| K081624 | INFX-8000F (INFINIX CSI AND INFINIX DPI) | Toshiba America Medical Systems, In.C | 2008-06-23 | 13 | 3 |
| K081582 | INFX-8000V, INFINIX-CFI AND INFINIX VFI | Toshiba America Medical Systems, In.C | 2008-06-17 | 12 | 1 |
| K081482 | CSBP-001A BODY ORGAN PERFUSION SYSTEM | Toshiba America Medical Systems, In.C | 2008-06-11 | 14 | 0 |
| K081065 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A, VER | Toshiba America Medical Systems, In.C | 2008-06-06 | 52 | 0 |
| K080211 | MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM | Toshiba America Medical Systems, In.C | 2008-03-14 | 45 | 8 |
| K080160 | APLIO ARTIDA, MODEL SSH-880CV DIAGNOSTIC ULTRASOUND SYSTEM | Toshiba America Medical Systems, In.C | 2008-02-08 | 16 | 0 |
| K080038 | VANTAGE TITAN, MODEL MRT-1504/S3 | Toshiba America Medical Systems, In.C | 2008-01-22 | 15 | 1 |
| K073259 | XIDF-100A/B1 IMAGE PROCESSOR | Toshiba America Medical Systems, In.C | 2007-12-20 | 30 | 0 |
| K073081 | JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X | Toshiba America Medical Systems, In.C | 2007-11-21 | 20 | 0 |
| K073165 | DRAD-3000E, RADREX-I | Toshiba America Medical Systems, In.C | 2007-11-16 | 7 | 1 |
| K072693 | CSNP-001A NEURO PACKAGE | Toshiba America Medical Systems, In.C | 2007-11-01 | 38 | 0 |
| K072826 | APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM | Toshiba America Medical Systems, In.C | 2007-10-24 | 21 | 0 |
| K072737 | CSCS-001A CALCIUM SCORING PACKAGE | Toshiba America Medical Systems, In.C | 2007-10-05 | 8 | 0 |
| K072606 | AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM | Toshiba America Medical Systems, In.C | 2007-10-02 | 15 | 4 |
| K072000 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A VERSIO | Toshiba America Medical Systems, In.C | 2007-07-30 | 7 | 0 |
| K063361 | EXCELART VANTAGE ATLAS, MODEL MRT-1503 | Toshiba America Medical Systems, In.C | 2006-11-21 | 14 | 1 |
| K063241 | CSTC-002A, EXTENDED FIELD OF VIEW SOFTWARE OPTION | Toshiba America Medical Systems, In.C | 2006-11-09 | 14 | 0 |
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