IQUANTIFY, VERSION 1.0


Device Classification Name

system, image processing, radiological

510(k) Number K011196
Device Name IQUANTIFY, VERSION 1.0
Original Applicant
INSIGHTFUL CORPORATION
1700 westlake ave.
suite 500
seattle, 
WA 
98109 -3044

Original Contact bradley t wyman
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 04/19/2001
Decision Date 11/08/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No