U-Systems, Inc.

U-Systems, Inc. holds 6 FDA 510(k) medical device clearances, first cleared 2001, most recent 2005, with 1 FDA device recall on record.

FDA recalls by U-Systems, Inc.

Z-1587-2013 — Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening.Class II·Terminated·2013-05-16

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

Recent clearances by U-Systems, Inc.

K052355 — AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUSCode IYO·2005-09-14
K032640 — FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEMCode IYO·2003-09-11
K022517 — USI-2000 ULTRASOUND SYSTEM WITH AUTOMATED SCANNING ACCESSORYCode IYN·2002-12-24
K013902 — U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM USI-2000Code IYN·2002-06-05
K013848 — U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000Code IYN·2002-04-08
K003479 — U-SYSTEMS ULTRASOUND SYSTEM USI-2000Code IYN·2001-01-18

Data sourced from openFDA. This site is unofficial and independent of the FDA.

Top product codes for U-Systems, Inc.

FDA recalls by U-Systems, Inc.

Recent clearances by U-Systems, Inc.