Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K112439 |
Device Name |
SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0 |
Applicant |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
419 WEST AVE. |
STAMFORD,
CT
06902 -6300
|
|
Applicant Contact |
JYH-SHYAN LIN |
Correspondent |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
419 WEST AVE. |
STAMFORD,
CT
06902 -6300
|
|
Correspondent Contact |
JYH-SHYAN LIN |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 08/24/2011 |
Decision Date | 10/17/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|