SHARP VIEW IMAGE ENHANCEMENT SYSTEM


Device Classification Name

system, image processing, radiological

510(k) Number K024028
Device Name SHARP VIEW IMAGE ENHANCEMENT SYSTEM
Original Applicant
CONTEXT VISION AB
storgatan 24
linkoping, 

SE

se-582 23

Original Contact kent strandlund
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 12/06/2002
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