MW100 (MAMMOGRAPHY) LCD MONITOR SYSTEM


Device Classification Name

system, image processing, radiological

510(k) Number K110596
Device Name MW100 (MAMMOGRAPHY) LCD MONITOR SYSTEM
Applicant
WIDE CORPORATION
1600 manchester way
corinth, 
TX 
76210

Applicant Contact carl alletto
Correspondent
WIDE CORPORATION
1600 manchester way
corinth, 
TX 
76210

Correspodent Contact carl alletto
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 03/02/2011
Decision Date 11/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No