Device Classification Name |
X-Ray, Tomography, Computed, Dental
|
510(k) Number |
K171012 |
Device Name |
Veraview X800 |
Applicant |
J.Morita USA, Inc. |
9 Mason |
Irvine,
CA
92618
|
|
Applicant Contact |
Keisuke Mori |
Correspondent |
Fish & Richardson P.C. |
1425 K Street, N.W., Suite 1100 |
Washingon DC,
DC
20005
|
|
Correspondent Contact |
Keith A. Barritt |
Regulation Number | 892.1750
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/04/2017 |
Decision Date | 12/19/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|