Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Siemens Medical Solutions USA, Inc. Ultrasound Gro · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132804 | ACUSON S1000 / S2000 / S3000 | Siemens Medical Solutions USA, Inc. Ultrasound Gro | 2013-10-24 | 48 | 3 |
| K132654 | ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. Ultrasound Gro | 2013-09-26 | 31 | 0 |
| K121646 | ACUSON X150 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X150 DIAG | Siemens Medical Solutions USA, Inc. Ultrasound Gro | 2012-06-22 | 17 | 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