Device Classification Name |
Whole Slide Imaging System
|
510(k) Number |
K232202 |
Device Name |
Aperio GT 450 DX |
Applicant |
Leica Biosystems Imaging, Inc. |
1360 Park Center Drive |
Vista,
CA
92081
|
|
Applicant Contact |
April Komplin |
Correspondent |
Leica Biosystems Imaging, Inc. |
1360 Park Center Drive |
Vista,
CA
92081
|
|
Correspondent Contact |
April Komplin |
Regulation Number | 864.3700
|
Classification Product Code |
|
Date Received | 07/25/2023 |
Decision Date | 04/16/2024 |
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
|
|
|