Siemens AG Medical Solutions
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 31
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
| K143196 | syngo.CT Lung CAD | May 12, 2015 |
| K130998 | SYNGO.VIA WEB VIEWER | January 3, 2014 |
| K123920 | SYNGO.VIA | January 18, 2013 |
| K120331 | SYNGO CT DYNAMIC ANGIO | April 13, 2012 |
| K111079 | SYNGO.VIA WEB VIEWER | May 13, 2011 |
| K101666 | SYNGO. PLAZA VA20A | August 10, 2010 |
| K100637 | SYNGO.CT CORONARY ANALYSIS | May 26, 2010 |
| K093612 | SYNGO.PLAZA | March 4, 2010 |
| K092067 | ABVS WORKPLACE | September 18, 2009 |
| K092519 | SYNGO.X | August 27, 2009 |
| K092013 | SYNGO VOLUME PERFUSION-CT BODY | July 17, 2009 |
| K082430 | SYNGO IMAGING XS | November 14, 2008 |
| K081734 | SYNGO IMAGING (VERSION V31) | July 3, 2008 |
| K072728 | SYNGO MULTIMODALITY WORKPLACE | April 22, 2008 |
| K073418 | SYNGO IMAGING CCF VA10A | February 29, 2008 |
| K073238 | SYNGO VOLUME PERFUSION-CT NEURO | January 3, 2008 |
| K073373 | SYNGO VOLUME PERFUSION-CT BODY | December 18, 2007 |
| K072909 | 1.5T 32-CHANNEL HEAD COIL AND 3T 32-CHANNEL HEAD COIL | October 31, 2007 |
| K071114 | SYNGO IMAGING (VERSION V30) | May 22, 2007 |
| K063762 | SYNGO CIRCULATION SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY | January 5, 2007 |