U-Systems, Inc.
Los Altos, CA, US
U-Systems, Inc. appears in FDA device records in Los Altos, CA. FDA records list 6 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for U-Systems, Inc. between 2001 and 2005. The busiest year on record is 2002, with 3. The most recent is 2005, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2002 | 3 |
| 2003 | 1 |
| 2005 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K052355 | AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS | IYO | Substantially Equivalent | |
| K032640 | FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM | IYO | Substantially Equivalent | |
| K022517 | USI-2000 ULTRASOUND SYSTEM WITH AUTOMATED SCANNING ACCESSORY | IYN | Substantially Equivalent | |
| K013902 | U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM USI-2000 | IYN | Substantially Equivalent | |
| K013848 | U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000 | IYN | Substantially Equivalent | |
| K003479 | U-SYSTEMS ULTRASOUND SYSTEM USI-2000 | IYN | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1587-2013 | Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening. | Devices labeled for an intended use not included in the existing 510(k) or PMA, in that, the user manual contains the Indication for Use of the soma v Platinum ABUS [a 510(k) product]. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain