PICUS ULTRASOUND IMAGING SYSTEMS


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K023512
Device Name PICUS ULTRASOUND IMAGING SYSTEMS
Original Applicant
PIE MEDICAL
7992 castleway drive
indianapolis, 
IN 
46250

Original Contact colleen densmore
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 10/21/2002
Decision Date 01/24/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No