Toshiba America Medical Systems, In.C
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 146
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K141472 | VANTAGE ELAN | September 19, 2014 |
| K133553 | KALARE | June 13, 2014 |
| K140729 | APLIO ARTIDA, V3.2 | May 23, 2014 |
| K132106 | INFINIX ANGIO WORKSTATION W/DTS SOFTWARE | November 12, 2013 |
| K131822 | ULTRAEXTEND USWS-900A V2.1 AND V3.1 | July 23, 2013 |
| K123097 | DOSE TRACKING SYSTEM MODEL XIDF-DTS801 | February 13, 2013 |
| K122613 | VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US | December 13, 2012 |
| K121076 | ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE | October 9, 2012 |
| K122842 | RADREX-I, SW V4.00 MODEL DRAD-3000E | October 9, 2012 |
| K122109 | AQUILION ONE VISION, V4.90 | September 21, 2012 |
| K112989 | AQUILION CXL | April 10, 2012 |
| K110066 | AQUILION PRIME | January 26, 2012 |
| K113052 | INFINIX-CCI | November 22, 2011 |
| K110870 | APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND | October 4, 2011 |
| K111633 | AQUILION LB MOVEMENT BASE KIT | August 25, 2011 |
| K103629 | PET-512MC TRANSESOPHAGEAL TRANSDUCER | February 2, 2011 |
| K101868 | INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V | September 7, 2010 |
| K100067 | MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM | January 28, 2010 |
| K093171 | VIAMO SSA-640A VERSION 1.2 | December 4, 2009 |
| K092948 | APLIO MX SSA-780A, VERSION 1.0 | October 9, 2009 |