Company ยท US
Toshiba America Medical Systems, In.C
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 2014. Name variants (Inc, Corp, punctuation) are merged.
146510(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 | 35 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 22 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 13 |
| LLZ | System, Image Processing, Radiological | 10 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 10 |
| ITX | Transducer, Ultrasonic, Diagnostic | 9 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 9 |
| KPS | System, Tomography, Computed, Emission | 6 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 5 |
| OWB | Interventional Fluoroscopic X-Ray System | 3 |
| IZI | System, X-Ray, Angiographic | 2 |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 2 |
| IZZ | Table, Radiographic, Non-Tilting, Powered | 2 |
| MOS | Coil, Magnetic Resonance, Specialty | 2 |
| DXK | Echocardiograph | 1 |
| DXT | Injector And Syringe, Angiographic | 1 |
| GXW | Echoencephalograph | 1 |
| IXR | Table, Radiographic, Tilting | 1 |
| IYD | Generator, Low Voltage, Therapeutic X-Ray | 1 |
| IYX | Camera, Scintillation (Gamma) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 19, 2014 | K141472 | VANTAGE ELAN Toshiba America Medical Systems, In.C | LNH |
| Jun 13, 2014 | K133553 | KALARE Toshiba America Medical Systems, In.C | JAA |
| May 23, 2014 | K140729 | APLIO ARTIDA, V3.2 Toshiba America Medical Systems, In.C | IYN |
| Nov 12, 2013 | K132106 | INFINIX ANGIO WORKSTATION W/DTS SOFTWARE Toshiba America Medical Systems, In.C | JAA |
| Jul 23, 2013 | K131822 | ULTRAEXTEND USWS-900A V2.1 AND V3.1 Toshiba America Medical Systems, In.C | LLZ |
| Feb 13, 2013 | K123097 | DOSE TRACKING SYSTEM MODEL XIDF-DTS801 Toshiba America Medical Systems, In.C | JAA |
| Dec 13, 2012 | K122613 | VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US Toshiba America Medical Systems, In.C | LNH |
| Oct 9, 2012 | K122842 | RADREX-I, SW V4.00 MODEL DRAD-3000E Toshiba America Medical Systems, In.C | MQB |
| Oct 9, 2012 | K121076 | ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE Toshiba America Medical Systems, In.C | LLZ |
| Sep 21, 2012 | K122109 | AQUILION ONE VISION, V4.90 Toshiba America Medical Systems, In.C | JAK |
| Apr 10, 2012 | K112989 | AQUILION CXL Toshiba America Medical Systems, In.C | JAK |
| Jan 26, 2012 | K110066 | AQUILION PRIME Toshiba America Medical Systems, In.C | JAK |
| Nov 22, 2011 | K113052 | INFINIX-CCI Toshiba America Medical Systems, In.C | MQB |
| Oct 4, 2011 | K110870 | APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM Toshiba America Medical Systems, In.C | IYN |
| Aug 25, 2011 | K111633 | AQUILION LB MOVEMENT BASE KIT Toshiba America Medical Systems, In.C | JAK |
| Feb 2, 2011 | K103629 | PET-512MC TRANSESOPHAGEAL TRANSDUCER Toshiba America Medical Systems, In.C | ITX |
| Sep 7, 2010 | K101868 | INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V Toshiba America Medical Systems, In.C | OWB |
| Jan 28, 2010 | K100067 | MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM Toshiba America Medical Systems, In.C | ITX |
| Dec 4, 2009 | K093171 | VIAMO SSA-640A VERSION 1.2 Toshiba America Medical Systems, In.C | IYN |
| Oct 9, 2009 | K092948 | APLIO MX SSA-780A, VERSION 1.0 Toshiba America Medical Systems, In.C | IYN |
| Jul 29, 2009 | K092179 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 4.0R001 Toshiba America Medical Systems, In.C | IYN |
| May 15, 2009 | K091295 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0 Toshiba America Medical Systems, In.C | ITX |
| Feb 13, 2009 | K083503 | DRAD30003/RADREX-I Toshiba America Medical Systems, In.C | KPR |
| Feb 6, 2009 | K090158 | APLIO ARTIDA V2.0 SSH-880CV Toshiba America Medical Systems, In.C | IYN |
| Dec 12, 2008 | K083282 | MODEL TSX-301B AQUILION CT SYSTEM Toshiba America Medical Systems, In.C | JAK |
| Oct 17, 2008 | K083014 | ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A Toshiba America Medical Systems, In.C | MOS |
| Oct 14, 2008 | K082684 | 4D VIEWER RADIOLOGY, MODEL USWP-100A Toshiba America Medical Systems, In.C | LLZ |
| Oct 10, 2008 | K082830 | INFX-8000H, INFINIX-I Toshiba America Medical Systems, In.C | JAA |
| Sep 23, 2008 | K082596 | ULTRAEXTEND USWS-900A Toshiba America Medical Systems, In.C | LLZ |
| Sep 12, 2008 | K082494 | DRAD3000E/RADREX-I Toshiba America Medical Systems, In.C | MQB |
| Aug 21, 2008 | K082244 | PCA-8000A, MARK 11, PET / CT SYSTEM Toshiba America Medical Systems, In.C | KPS |
| Aug 12, 2008 | K082119 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 3.0 Toshiba America Medical Systems, In.C | IYN |
| Jun 23, 2008 | K081624 | INFX-8000F (INFINIX CSI AND INFINIX DPI) Toshiba America Medical Systems, In.C | MQB |
| Jun 23, 2008 | K081621 | INFX-8000C (INFINIX CC-I AND VC-I) Toshiba America Medical Systems, In.C | JAA |
| Jun 17, 2008 | K081582 | INFX-8000V, INFINIX-CFI AND INFINIX VFI Toshiba America Medical Systems, In.C | JAA |
| Jun 11, 2008 | K081482 | CSBP-001A BODY ORGAN PERFUSION SYSTEM Toshiba America Medical Systems, In.C | JAK |
| Jun 6, 2008 | K081065 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A, VERSION 2.2 Toshiba America Medical Systems, In.C | IYN |
| Mar 14, 2008 | K080211 | MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM Toshiba America Medical Systems, In.C | JAK |
| Feb 8, 2008 | K080160 | APLIO ARTIDA, MODEL SSH-880CV DIAGNOSTIC ULTRASOUND SYSTEM Toshiba America Medical Systems, In.C | IYN |
| Jan 22, 2008 | K080038 | VANTAGE TITAN, MODEL MRT-1504/S3 Toshiba America Medical Systems, In.C | LNH |
| Dec 20, 2007 | K073259 | XIDF-100A/B1 IMAGE PROCESSOR Toshiba America Medical Systems, In.C | LLZ |
| Nov 21, 2007 | K073081 | JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X Toshiba America Medical Systems, In.C | LNH |
| Nov 16, 2007 | K073165 | DRAD-3000E, RADREX-I Toshiba America Medical Systems, In.C | MQB |
| Nov 1, 2007 | K072693 | CSNP-001A NEURO PACKAGE Toshiba America Medical Systems, In.C | JAK |
| Oct 24, 2007 | K072826 | APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM Toshiba America Medical Systems, In.C | ITX |
| Oct 5, 2007 | K072737 | CSCS-001A CALCIUM SCORING PACKAGE Toshiba America Medical Systems, In.C | JAK |
| Oct 2, 2007 | K072606 | AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM Toshiba America Medical Systems, In.C | JAK |
| Jul 30, 2007 | K072000 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A VERSION 2.0 Toshiba America Medical Systems, In.C | IYN |
| Nov 21, 2006 | K063361 | EXCELART VANTAGE ATLAS, MODEL MRT-1503 Toshiba America Medical Systems, In.C | LNH |
| Nov 9, 2006 | K063241 | CSTC-002A, EXTENDED FIELD OF VIEW SOFTWARE OPTION Toshiba America Medical Systems, In.C | JAK |
Newest 50 of 146.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||