USI-2000 ULTRASOUND SYSTEM WITH AUTOMATED SCANNING ACCESSORY


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K022517
Device Name USI-2000 ULTRASOUND SYSTEM WITH AUTOMATED SCANNING ACCESSORY
Original Applicant
U-SYSTEMS, INC.
2081 longden circle
los altos,, 
CA 
94204

Original Contact sheila w pickering
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 07/30/2002
Decision Date 12/24/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No