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U-Systems, Inc.

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K052355	AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS	IYO	2005-09-14	View
510(k)	K032640	FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM	IYO	2003-09-11	View
510(k)	K022517	USI-2000 ULTRASOUND SYSTEM WITH AUTOMATED SCANNING ACCESSORY	IYN	2002-12-24	View
510(k)	K013902	U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM USI-2000	IYN	2002-06-05	View
510(k)	K013848	U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000	IYN	2002-04-08	View
510(k)	K003479	U-SYSTEMS ULTRASOUND SYSTEM USI-2000	IYN	2001-01-18	View

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