21.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR


Device Classification Name

system, image processing, radiological

510(k) Number K111496
Device Name 21.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR
Applicant
TOTOKU ELECTRIC CO., LTD
300 oya
ueda, nagano, 

JP

386-0192

Applicant Contact tsukasa tashiro
Correspondent
TOTOKU ELECTRIC CO., LTD
300 oya
ueda, nagano, 

JP

386-0192

Correspodent Contact tsukasa tashiro
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 05/31/2011
Decision Date 09/26/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No