Medical Device Manufacturer · US , Los Altos, , CA

U-Systems, Inc. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2001

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - U-Systems, Inc. Radiology ✕

6 devices

1-6 of 6

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