Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Siemens Medical Systems, Inc. · Predicate Candidate Screening
25 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
39 daysmedian FDA review time
276 days90th percentile
25clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K133646 | ADMIRE | Siemens Medical Systems, Inc. | 2014-06-20 | 205 | 0 |
| K130901 | SOMATOM DEFINITION AS OPEN | Siemens Medical Systems, Inc. | 2014-01-02 | 276 | 0 |
| K123540 | SYNGO CT PULMO 3D | Siemens Medical Systems, Inc. | 2013-08-29 | 283 | 0 |
| K123541 | SYNGO.CT NEURO PERFUSION | Siemens Medical Systems, Inc. | 2013-04-02 | 134 | 0 |
| K122909 | SYNGO SINGLE SOURCE DUAL ENGERY | Siemens Medical Systems, Inc. | 2012-12-27 | 97 | 0 |
| K122471 | SOMATOM DEFINITION | Siemens Medical Systems, Inc. | 2012-09-11 | 28 | 3 |
| K120579 | SOMATOM DEFINITION EDGE | Siemens Medical Systems, Inc. | 2012-05-23 | 86 | 2 |
| K121072 | SOMATOM DEFINITION FLASH | Siemens Medical Systems, Inc. | 2012-05-08 | 29 | 3 |
| K113342 | SOMATOM DEFINITION FLASH | Siemens Medical Systems, Inc. | 2011-12-29 | 45 | 1 |
| K052216 | SOMATOM DEFINITION | Siemens Medical Systems, Inc. | 2005-09-08 | 36 | 0 |
| K051602 | AXIOM SIRESKOP SD | Siemens Medical Systems, Inc. | 2005-07-07 | 21 | 5 |
| K042646 | DYNACT | Siemens Medical Systems, Inc. | 2004-10-19 | 21 | 0 |
| K042328 | SOMATOM SPIRIT | Siemens Medical Systems, Inc. | 2004-09-14 | 18 | 1 |
| K040970 | LEONARDO | Siemens Medical Systems, Inc. | 2004-07-08 | 85 | 1 |
| K040675 | AXIOM ARTIS U | Siemens Medical Systems, Inc. | 2004-06-10 | 90 | 1 |
| K040577 | SOMATOM PROJECT P30L | Siemens Medical Systems, Inc. | 2004-03-22 | 18 | 1 |
| K040347 | SIREMOBIL ISO-C 3D | Siemens Medical Systems, Inc. | 2004-03-09 | 26 | 1 |
| K033238 | MOBILETTE XP AND MOBILETT XPHYBRID | Siemens Medical Systems, Inc. | 2003-11-14 | 39 | 4 |
| K020440 | NEWCOR | Siemens Medical Systems, Inc. | 2002-12-03 | 295 | 8 |
| K023687 | SOMATOM EMOTION 6 CT SYSTEMS | Siemens Medical Systems, Inc. | 2002-11-22 | 21 | 5 |
| K023571 | 6 CHANNEL BODY COIL | Siemens Medical Systems, Inc. | 2002-11-20 | 27 | 0 |
| K020353 | OMNIA X/XS ULTRASOUND SYSTEM | Siemens Medical Systems, Inc. | 2002-02-13 | 9 | 0 |
| K013826 | AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM) | Siemens Medical Systems, Inc. | 2002-02-01 | 74 | 7 |
| K013586 | MAGNETOM TRIO SYSTEM | Siemens Medical Systems, Inc. | 2001-12-28 | 59 | 4 |
| K013522 | SOMATOM P30 CT SYSTEMS | Siemens Medical Systems, Inc. | 2001-11-07 | 15 | 7 |
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