Device Classification Name |
System, X-Ray, Stationary
|
510(k) Number |
K122454 |
Device Name |
FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION |
Applicant |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
419 WEST AVE. |
STAMFORD,
CT
06902 -6300
|
|
Applicant Contact |
DEBBIE PEACOCK |
Correspondent |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
419 WEST AVE. |
STAMFORD,
CT
06902 -6300
|
|
Correspondent Contact |
DEBBIE PEACOCK |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 08/13/2012 |
Decision Date | 11/20/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|