Device Classification Name |
whole slide imaging system
|
510(k) Number |
K192259 |
Device Name |
Philips IntelliSite Pathology Solution |
Applicant |
Philips Electronics Nederland B.V. |
Veenpluis 6 |
Best,
NL
5684 PC
|
|
Applicant Contact |
Liselotte Kornmann |
Correspondent |
Philips Electronics Nederland B.V. |
Veenpluis 6 |
Best,
NL
5684 PC
|
|
Correspondent Contact |
Liselotte Kornmann |
Regulation Number | 864.3700
|
Classification Product Code |
|
Date Received | 08/21/2019 |
Decision Date | 09/20/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Pathology
|
510k Review Panel |
Pathology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|