Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Siemens Medical Solution USA, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
182 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220433 | syngo Application Software (VE21) | Siemens Medical Solution USA, Inc. | 2022-08-16 | 182 | 0 |
| K201156 | ARTIS pheno (VE2) | Siemens Medical Solution USA, Inc. | 2020-06-29 | 60 | 1 |
| K193178 | Biograph Horizon | Siemens Medical Solution USA, Inc. | 2020-02-12 | 86 | 1 |
| K190780 | syngo Application Software | Siemens Medical Solution USA, Inc. | 2019-09-12 | 169 | 0 |
| K190757 | MAGNETOM Avanto Fit | Siemens Medical Solution USA, Inc. | 2019-05-31 | 67 | 0 |
| K181407 | Artis zee/zeego & Artis Q/Q.zen | Siemens Medical Solution USA, Inc. | 2018-08-15 | 77 | 20 |
| K163286 | ARTIS pheno | Siemens Medical Solution USA, Inc. | 2017-03-09 | 107 | 4 |
| K163285 | syngo Application Software | Siemens Medical Solution USA, Inc. | 2017-02-14 | 84 | 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