Device Classification Name |
whole slide imaging system
|
510(k) Number |
K213883 |
Device Name |
NanoZoomer S360MD Slide scanner system |
Applicant |
Hamamatsu Photonics K.K. |
812, Joko-cho, Higashi-ku |
Hamamatsu City,
JP
431-3196
|
|
Applicant Contact |
Shinichi Fujisaka |
Correspondent |
Hyman, Phelps & McNamara, P.C |
700 Thirteenth Street NW, Suite 1200 |
DC,
DC
20005
|
|
Correspondent Contact |
Jeffrey Gibbs |
Regulation Number | 864.3700
|
Classification Product Code |
|
Date Received | 12/13/2021 |
Decision Date | 09/27/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Pathology
|
510k Review Panel |
Pathology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|