Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Siemens AG Medical Solutions · Predicate Candidate Screening
31 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
25 daysmedian FDA review time
101 days90th percentile
31clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K143196 | syngo.CT Lung CAD | Siemens AG Medical Solutions | 2015-05-12 | 187 | 0 |
| K130998 | SYNGO.VIA WEB VIEWER | Siemens AG Medical Solutions | 2014-01-03 | 268 | 0 |
| K123920 | SYNGO.VIA | Siemens AG Medical Solutions | 2013-01-18 | 29 | 0 |
| K120331 | SYNGO CT DYNAMIC ANGIO | Siemens AG Medical Solutions | 2012-04-13 | 71 | 0 |
| K111079 | SYNGO.VIA WEB VIEWER | Siemens AG Medical Solutions | 2011-05-13 | 25 | 0 |
| K101666 | SYNGO. PLAZA VA20A | Siemens AG Medical Solutions | 2010-08-10 | 57 | 3 |
| K100637 | SYNGO.CT CORONARY ANALYSIS | Siemens AG Medical Solutions | 2010-05-26 | 82 | 0 |
| K093612 | SYNGO.PLAZA | Siemens AG Medical Solutions | 2010-03-04 | 101 | 15 |
| K092067 | ABVS WORKPLACE | Siemens AG Medical Solutions | 2009-09-18 | 71 | 0 |
| K092519 | SYNGO.X | Siemens AG Medical Solutions | 2009-08-27 | 9 | 3 |
| K092013 | SYNGO VOLUME PERFUSION-CT BODY | Siemens AG Medical Solutions | 2009-07-17 | 11 | 0 |
| K082430 | SYNGO IMAGING XS | Siemens AG Medical Solutions | 2008-11-14 | 84 | 11 |
| K081734 | SYNGO IMAGING (VERSION V31) | Siemens AG Medical Solutions | 2008-07-03 | 14 | 4 |
| K072728 | SYNGO MULTIMODALITY WORKPLACE | Siemens AG Medical Solutions | 2008-04-22 | 209 | 0 |
| K073418 | SYNGO IMAGING CCF VA10A | Siemens AG Medical Solutions | 2008-02-29 | 86 | 0 |
| K073238 | SYNGO VOLUME PERFUSION-CT NEURO | Siemens AG Medical Solutions | 2008-01-03 | 48 | 0 |
| K073373 | SYNGO VOLUME PERFUSION-CT BODY | Siemens AG Medical Solutions | 2007-12-18 | 15 | 0 |
| K072909 | 1.5T 32-CHANNEL HEAD COIL AND 3T 32-CHANNEL HEAD COIL | Siemens AG Medical Solutions | 2007-10-31 | 19 | 0 |
| K071114 | SYNGO IMAGING (VERSION V30) | Siemens AG Medical Solutions | 2007-05-22 | 32 | 7 |
| K063762 | SYNGO CIRCULATION SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALI | Siemens AG Medical Solutions | 2007-01-05 | 16 | 0 |
| K062673 | MODIFICATION TO SYNGO INSPACE 4D | Siemens AG Medical Solutions | 2006-09-22 | 14 | 0 |
| K061964 | SYNGO MULTIMODALITY WORKPLACE | Siemens AG Medical Solutions | 2006-07-27 | 15 | 0 |
| K052775 | SYNGO MULTIMODALITY WORKPLACE (SYNGO MM WP) | Siemens AG Medical Solutions | 2005-10-31 | 28 | 1 |
| K052461 | SYNGO IMAGING VERSION V20A | Siemens AG Medical Solutions | 2005-09-22 | 14 | 3 |
| K052029 | SYNGO CIRCULATION | Siemens AG Medical Solutions | 2005-08-09 | 13 | 0 |
| K043469 | SYNGO INSPACE 4D | Siemens AG Medical Solutions | 2005-02-03 | 49 | 0 |
| K042832 | SIENET COSMOS (VERSION V15A) | Siemens AG Medical Solutions | 2004-10-28 | 15 | 3 |
| K042605 | COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY | Siemens AG Medical Solutions | 2004-10-08 | 14 | 0 |
| K033832 | SYNGO PERFUSION-CT | Siemens AG Medical Solutions | 2003-12-23 | 13 | 0 |
| K033831 | SIENET COSMOS | Siemens AG Medical Solutions | 2003-12-19 | 9 | 1 |
| K033374 | LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY | Siemens AG Medical Solutions | 2003-11-06 | 15 | 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