Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K081242 |
Device Name |
21.3 INCH (53CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS51I2, (MDL2123A) |
Applicant |
TOKOTU ELECTRIC CO., LTD. |
300 OYA, UEDA |
NAGANO,
JP
386-0192
|
|
Applicant Contact |
MIKIO HASEGAWA |
Correspondent |
TOKOTU ELECTRIC CO., LTD. |
300 OYA, UEDA |
NAGANO,
JP
386-0192
|
|
Correspondent Contact |
MIKIO HASEGAWA |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 05/01/2008 |
Decision Date | 06/11/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|