Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
U-Systems, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
139 daysmedian FDA review time
191 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K052355 | AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS | U-Systems, Inc. | 2005-09-14 | 16 | 0 |
| K032640 | FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTE | U-Systems, Inc. | 2003-09-11 | 15 | 0 |
| K022517 | USI-2000 ULTRASOUND SYSTEM WITH AUTOMATED SCANNING ACCESSORY | U-Systems, Inc. | 2002-12-24 | 147 | 0 |
| K013902 | U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM USI-2000 | U-Systems, Inc. | 2002-06-05 | 191 | 0 |
| K013848 | U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000 | U-Systems, Inc. | 2002-04-08 | 139 | 0 |
| K003479 | U-SYSTEMS ULTRASOUND SYSTEM USI-2000 | U-Systems, Inc. | 2001-01-18 | 70 | 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