DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI


Device Classification Name

system, image processing, radiological

510(k) Number K080351
Device Name DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI
Applicant
DEXELA LTD
200 west street
waltham, 
MA 
01851

Applicant Contact barry sall
Correspondent
DEXELA LTD
200 west street
waltham, 
MA 
01851

Correspodent Contact barry sall
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 02/11/2008
Decision Date 04/22/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No