IVUS PLUS


Device Classification Name

system, image processing, radiological

510(k) Number K024103
Device Name IVUS PLUS
Original Applicant
INDEC SYSTEMS, INC.
505 e. evelyn
suite d
mountain view, 
CA 
94041

Original Contact carol hubler
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 12/12/2002
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