OBSERVER ULTRASOUND REPORTING AND IMAGING SYSTEM


Device Classification Name

system, image processing, radiological

510(k) Number K022877
Device Name OBSERVER ULTRASOUND REPORTING AND IMAGING SYSTEM
Original Applicant
VISION CHIPS, INC.
27111 aliso creek rd, ste. 120
aliso viejo, 
CA 
92656

Original Contact ronald “jock” philip
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 08/30/2002
Decision Date 02/05/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No