HDI 5000 ULTRASOUND SYSTEM WITH EXTENDED FIELD OF VIEW IMAGING


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K002003
Device Name HDI 5000 ULTRASOUND SYSTEM WITH EXTENDED FIELD OF VIEW IMAGING
Original Applicant
ATL ULTRASOUND, INC.
p.o. box 3003
bothell, 
WA 
98041 -3003

Original Contact terrence j sweeney
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 06/30/2000
Decision Date 07/13/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party Yes

Combination Product

No