FDA.reportPublic FDA data

De Novo DEN160056

Device
Philips IntelliSite Pathology Solution
Contact
esther abels
De Novo number
DEN160056
Product code
PSY
Regulation
864.3700
Classification name
whole slide imaging system
Decision
granted (DENG)
Decision date
2017-04-12
Date received
2016-12-01
Classification advisory
Pathology
Review advisory
Pathology
Type
Direct

Current FDA Classification#

Product code
PSY
Device name
Whole Slide Imaging System
Medical specialty
Pathology
Device class
2
Regulation
864.3700
Implant
N
Life sustain/support
N