U-Systems, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “U-Systems, Inc.” (first 2001, latest 2005), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 104 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 4 | 4 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | 2 |
Review panels
- Radiology (6)
Most recent U-Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K052355 | AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS | IYO | 2005-09-14 | 16 |
| K032640 | FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM | IYO | 2003-09-11 | 15 |
| K022517 | USI-2000 ULTRASOUND SYSTEM WITH AUTOMATED SCANNING ACCESSORY | IYN | 2002-12-24 | 147 |
| K013902 | U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM USI-2000 | IYN | 2002-06-05 | 191 |
| K013848 | U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000 | IYN | 2002-04-08 | 139 |
| K003479 | U-SYSTEMS ULTRASOUND SYSTEM USI-2000 | IYN | 2001-01-18 | 70 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2013-05-16.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named U-Systems, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01424956: CRRS-4 Pivotal Somo•v™ ABUS ROC Reader Observer Study (Completed, started 2011-07)
- NCT00816530: A Clinical Study to Evaluate Somo•v and Digital Mammography Together as a Breast Cancer Screening Method, Compared to Digital Mammography Alone, in Women With Dense Breasts. (Completed, started 2009-03)
Frequently asked questions
How many FDA 510(k) clearances are listed under U-Systems, Inc.?
FDA lists 6 510(k) clearances under the applicant name “U-Systems, Inc.” (first 2001, latest 2005), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by U-Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name U-Systems, Inc. is 104 days.
Which FDA product codes appear under U-Systems, Inc.?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 4); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 2).
Next steps
- See all 6 U-Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYN, U-Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.