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

U-Systems, Inc. has 6 FDA 510(k) cleared medical devices. Based in Los Altos,, US.

Historical record: 6 cleared submissions from 2001 to 2005. Primary specialty: Radiology.

Browse the FDA 510(k) cleared devices submitted by U-Systems, Inc. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - U-Systems, Inc.
6 devices
1-6 of 6
Cleared Sep 14, 2005
AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS
K052355 · IYO
Radiology · 16d
Cleared Sep 11, 2003
FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM
K032640 · IYO
Radiology · 15d
Cleared Dec 24, 2002
USI-2000 ULTRASOUND SYSTEM WITH AUTOMATED SCANNING ACCESSORY
K022517 · IYN
Radiology · 147d
Cleared Jun 05, 2002
U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM USI-2000
K013902 · IYN
Radiology · 191d
Cleared Apr 08, 2002
U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000
K013848 · IYN
Radiology · 139d
Cleared Jan 18, 2001
U-SYSTEMS ULTRASOUND SYSTEM USI-2000
K003479 · IYN
Radiology · 70d
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