U-systems Inc
FDA Regulatory Profile
U-systems Inc appears in FDA public data with 1 recall, 6 510(k) clearances, 6 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1587-2013, Class II) was initiated on May 16, 2013. Its most recent 510(k) clearance was granted on September 14, 2005.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 6
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1587-2013 | Class II | Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an ad | May 16, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K052355 | AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS | September 14, 2005 |
| K032640 | FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM | September 11, 2003 |
| K022517 | USI-2000 ULTRASOUND SYSTEM WITH AUTOMATED SCANNING ACCESSORY | December 24, 2002 |
| K013902 | U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM USI-2000 | June 5, 2002 |
| K013848 | U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000 | April 8, 2002 |
| K003479 | U-SYSTEMS ULTRASOUND SYSTEM USI-2000 | January 18, 2001 |