Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K120679 |
Device Name |
SYNAPSE 3D NODULE ANALYSIS |
Applicant |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
419 WEST AVE. |
STAMFORD,
CT
06902 -6300
|
|
Applicant Contact |
JYH-SHYAN LIN |
Correspondent |
FUJIFILM MEDICAL SYSTEMS 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 | 03/06/2012 |
Decision Date | 06/01/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|