Toshiba America Medical Systems, In.C
Tustin, CA, US
Toshiba America Medical Systems, In.C appears in FDA device records in Tustin, CA. FDA records list 146 510(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
- 146
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 146FDA records hold 146 510(k) clearances for Toshiba America Medical Systems, In.C between 1989 and 2014. The busiest year on record is 2008, with 16. The most recent is 2014, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 2 |
| 1990 | 11 |
| 1991 | 3 |
| 1992 | 7 |
| 1993 | 3 |
| 1994 | 7 |
| 1995 | 8 |
| 1996 | 5 |
| 1997 | 4 |
| 1998 | 8 |
| 1999 | 8 |
| 2000 | 1 |
| 2001 | 5 |
| 2002 | 6 |
| 2003 | 4 |
| 2004 | 2 |
| 2005 | 7 |
| 2006 | 7 |
| 2007 | 8 |
| 2008 | 16 |
| 2009 | 6 |
| 2010 | 2 |
| 2011 | 4 |
| 2012 | 6 |
| 2013 | 3 |
| 2014 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K141472 | VANTAGE ELAN | LNH | Substantially Equivalent | |
| K133553 | KALARE | JAA | Substantially Equivalent | |
| K140729 | APLIO ARTIDA, V3.2 | IYN | Substantially Equivalent | |
| K132106 | INFINIX ANGIO WORKSTATION W/DTS SOFTWARE | JAA | Substantially Equivalent | |
| K131822 | ULTRAEXTEND USWS-900A V2.1 AND V3.1 | LLZ | Substantially Equivalent | |
| K123097 | DOSE TRACKING SYSTEM MODEL XIDF-DTS801 | JAA | Substantially Equivalent | |
| K122613 | VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US | LNH | Substantially Equivalent | |
| K122842 | RADREX-I, SW V4.00 MODEL DRAD-3000E | MQB | Substantially Equivalent | |
| K121076 | ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE | LLZ | Substantially Equivalent | |
| K122109 | AQUILION ONE VISION, V4.90 | JAK | Substantially Equivalent | |
| K112989 | AQUILION CXL | JAK | Substantially Equivalent | |
| K110066 | AQUILION PRIME | JAK | Substantially Equivalent | |
| K113052 | INFINIX-CCI | MQB | Substantially Equivalent | |
| K110870 | APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K111633 | AQUILION LB MOVEMENT BASE KIT | JAK | Substantially Equivalent | |
| K103629 | PET-512MC TRANSESOPHAGEAL TRANSDUCER | ITX | Substantially Equivalent | |
| K101868 | INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V | OWB | Substantially Equivalent | |
| K100067 | MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM | ITX | Substantially Equivalent | |
| K093171 | VIAMO SSA-640A VERSION 1.2 | IYN | Substantially Equivalent | |
| K092948 | APLIO MX SSA-780A, VERSION 1.0 | IYN | Substantially Equivalent | |
| K092179 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 4.0R001 | IYN | Substantially Equivalent | |
| K091295 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0 | ITX | Substantially Equivalent | |
| K083503 | DRAD30003/RADREX-I | KPR | Substantially Equivalent | |
| K090158 | APLIO ARTIDA V2.0 SSH-880CV | IYN | Substantially Equivalent | |
| K083282 | MODEL TSX-301B AQUILION CT SYSTEM | JAK | Substantially Equivalent | |
| K083014 | ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A | MOS | Substantially Equivalent | |
| K082684 | 4D VIEWER RADIOLOGY, MODEL USWP-100A | LLZ | Substantially Equivalent | |
| K082830 | INFX-8000H, INFINIX-I | JAA | Substantially Equivalent | |
| K082596 | ULTRAEXTEND USWS-900A | LLZ | Substantially Equivalent | |
| K082494 | DRAD3000E/RADREX-I | MQB | Substantially Equivalent | |
| K082244 | PCA-8000A, MARK 11, PET / CT SYSTEM | KPS | Substantially Equivalent | |
| K082119 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 3.0 | IYN | Substantially Equivalent | |
| K081624 | INFX-8000F (INFINIX CSI AND INFINIX DPI) | MQB | Substantially Equivalent | |
| K081621 | INFX-8000C (INFINIX CC-I AND VC-I) | JAA | Substantially Equivalent | |
| K081582 | INFX-8000V, INFINIX-CFI AND INFINIX VFI | JAA | Substantially Equivalent | |
| K081482 | CSBP-001A BODY ORGAN PERFUSION SYSTEM | JAK | Substantially Equivalent | |
| K081065 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A, VERSION 2.2 | IYN | Substantially Equivalent | |
| K080211 | MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM | JAK | Substantially Equivalent | |
| K080160 | APLIO ARTIDA, MODEL SSH-880CV DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K080038 | VANTAGE TITAN, MODEL MRT-1504/S3 | LNH | Substantially Equivalent | |
| K073259 | XIDF-100A/B1 IMAGE PROCESSOR | LLZ | Substantially Equivalent | |
| K073081 | JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X | LNH | Substantially Equivalent | |
| K073165 | DRAD-3000E, RADREX-I | MQB | Substantially Equivalent | |
| K072693 | CSNP-001A NEURO PACKAGE | JAK | Substantially Equivalent | |
| K072826 | APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM | ITX | Substantially Equivalent | |
| K072737 | CSCS-001A CALCIUM SCORING PACKAGE | JAK | Substantially Equivalent | |
| K072606 | AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM | JAK | Substantially Equivalent | |
| K072000 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A VERSION 2.0 | IYN | Substantially Equivalent | |
| K063361 | EXCELART VANTAGE ATLAS, MODEL MRT-1503 | LNH | Substantially Equivalent | |
| K063241 | CSTC-002A, EXTENDED FIELD OF VIEW SOFTWARE OPTION | JAK | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- IYXCamera, Scintillation (Gamma)
- MOSCoil, Magnetic Resonance, Specialty
- KPWDevice, Beam Limiting, X-Ray, Diagnostic
- LMADigitizer, Image, Radiological
- DXKEchocardiograph
- GXWEchoencephalograph
- IZOGenerator, High-Voltage, X-Ray, Diagnostic
- IYDGenerator, Low Voltage, Therapeutic X-Ray
- OXOImage-Intensified Fluoroscopic X-Ray System, Mobile
- DXTInjector And Syringe, Angiographic
- OWBInterventional Fluoroscopic X-Ray System
- MAAMonitor, Fetal Doppler Ultrasound
- MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
- LMDSystem, Digital Image Communications, Radiological
- LLZSystem, Image Processing, Radiological
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- LNHSystem, Nuclear Magnetic Resonance Imaging
- LNISystem, Nuclear Magnetic Resonance Spectroscopic
- KPQSystem, Simulation, Radiation Therapy
- JWMSystem, Tomographic, Nuclear
- KPSSystem, Tomography, Computed, Emission
- IZISystem, X-Ray, Angiographic
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- KPRSystem, X-Ray, Stationary
- JAKSystem, X-Ray, Tomography, Computed
- IZZTable, Radiographic, Non-Tilting, Powered
- IXRTable, Radiographic, Tilting
- KXJTable, Radiologic
- 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