Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K181773 |
Device Name |
Synapse 3D Optional Tools |
Applicant |
FUJIFILM Corporation |
798 Miyanodai Kaisei-Machi |
Ashigarakami-Gun,
JP
258-8538
|
|
Applicant Contact |
Randy Vader |
Correspondent |
FUJIFILM Medical Systems U.S.A., Inc. |
419 West Avenue |
Stamford,
CT
06902
|
|
Correspondent Contact |
Jeffrey Wan |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 07/03/2018 |
Decision Date | 09/25/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|