U-Systems, Inc. - FDA 510(k) Cleared Devices
Recent clearances: AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS, FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM, USI-2000 ULTRASOUND SYSTEM WITH AUTOMATED SCANNING ACCESSORY
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - U-Systems, Inc. Radiology ✕
6 devices
Cleared
Sep 14, 2005
AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS
Radiology
16d
Cleared
Sep 11, 2003
FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM
Radiology
15d
Cleared
Dec 24, 2002
USI-2000 ULTRASOUND SYSTEM WITH AUTOMATED SCANNING ACCESSORY
Radiology
147d
Cleared
Jun 05, 2002
U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM USI-2000
Radiology
191d
Cleared
Apr 08, 2002
U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000
Radiology
139d
Cleared
Jan 18, 2001
U-SYSTEMS ULTRASOUND SYSTEM USI-2000
Radiology
70d