Device Classification Name |
Solid State X-Ray Imager (Flat Panel/Digital Imager)
|
510(k) Number |
K192932 |
Device Name |
FDR D-EVO III flat panel detector system |
Applicant |
FUJIFILM Corporation |
798 Miyanodai Kaisei-Machi |
Ashigarakami-Gun,
JP
258-8538
|
|
Applicant Contact |
Randy Vader |
Correspondent |
FUJIFILM Medical Systems U.S.A, Inc. |
81 Hartwell Avenue, Suite 300 |
Lexington,
MA
02421
|
|
Correspondent Contact |
Kamila Sak |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 10/17/2019 |
Decision Date | 11/12/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|