Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K120361 |
Device Name |
SYNAPSE 3D BASE TOOLS |
Applicant |
FUJIFILM MEDICAL SYSTEMS USA, INC. |
419 WEST AVENUE |
STAMFORD,
CT
06902
|
|
Applicant Contact |
DEBBIE PEACOCK |
Correspondent |
FUJIFILM MEDICAL SYSTEMS USA, INC. |
419 WEST AVENUE |
STAMFORD,
CT
06902
|
|
Correspondent Contact |
DEBBIE PEACOCK |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 02/06/2012 |
Decision Date | 04/06/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|