Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Siemens AG — Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
48 daysmedian FDA review time
87 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150843 | syngo®.via (version VB10A) | Siemens AG | 2015-04-24 | 25 | 0 |
| K123375 | SYNGO.VIA | Siemens AG | 2012-11-20 | 19 | 5 |
| K110366 | SYNGO.CT CARDIAC FUNCTION | Siemens AG | 2011-04-12 | 64 | 0 |
| K071310 | SYNGO CT ONCOLOGY SOFTWARE PACKAGE | Siemens AG | 2007-06-08 | 30 | 0 |
| K063507 | SYNGO NEURO PBV CT | Siemens AG | 2006-11-30 | 10 | 0 |
| K063373 | FLEX LOOP COIL SET 3T | Siemens AG | 2006-11-17 | 9 | 0 |
| K053024 | SYNGO NEURO DSA CT | Siemens AG | 2005-11-04 | 14 | 0 |
| K050867 | SYNGO BODY PERFUSION-CT | Siemens AG | 2005-04-14 | 8 | 0 |
| K043122 | SMD 21500 OR DSB-2103-D-5MP-5M PIXEL GRAYSCALE FLAT PANEL DI | Siemens AG | 2005-02-09 | 89 | 0 |
| K032280 | SIREMOBIL ISO-C 3D | Siemens AG | 2003-09-10 | 48 | 0 |
| K972436 | T1 LINE DENTAL HANDPIECES | Siemens AG | 1997-09-22 | 84 | 0 |
| K972312 | SIEMENS ORTHOPHOS DS/DS CEPH | Siemens AG | 1997-09-15 | 87 | 0 |
| K972276 | CEREC 2 CROWN SOFTWARE | Siemens AG | 1997-08-15 | 58 | 0 |
| K965238 | T1 CONTROL HIGH SPEED DENTAL HANDPIECE | Siemens AG | 1997-03-19 | 78 | 0 |
| K952533 | SIENET DICOM GATEWAY | Siemens AG | 1995-08-23 | 83 | 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