Company ยท US
U-Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2005. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 14, 2005 | K052355 | AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS U-Systems, Inc. | IYO |
| Sep 11, 2003 | K032640 | FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM U-Systems, Inc. | IYO |
| Dec 24, 2002 | K022517 | USI-2000 ULTRASOUND SYSTEM WITH AUTOMATED SCANNING ACCESSORY U-Systems, Inc. | IYN |
| Jun 5, 2002 | K013902 | U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM USI-2000 U-Systems, Inc. | IYN |
| Apr 8, 2002 | K013848 | U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000 U-Systems, Inc. | IYN |
| Jan 18, 2001 | K003479 | U-SYSTEMS ULTRASOUND SYSTEM USI-2000 U-Systems, Inc. | IYN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2013 | U-systems Inc Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound.
Indicated as an adjunct to mammography for breast cancer screening. Terminated |
PAA | K080930 |