510(k) DEN160056
DEN160056 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Nederland B.V. for the device "Philips IntelliSite Pathology Solution". The FDA issued a decision of De Novo granted on Apr 12, 2017. The device falls under product code PSY (Whole Slide Imaging System), a Class II device regulated under 21 CFR 864.3700. Philips Medical Systems Nederland B.V. has 106 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo granted)
- Decision Date
- Apr 12, 2017
- Date Received
- Dec 1, 2016
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Whole Slide Imaging System
- Device Class
- Class II
- Regulation Number
- 864.3700
- Review Panel
- PA
- Submission Type
- 510(k)
The whole slide imaging system is an automated digital slide creation, viewing, and management system intended as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue. The system generates digital images that would otherwise be appropriate for manual visualization by conventional brightfield microscopy. The whole slide imaging system is not intended for use with slides prepared from frozen tissue, cytology, and non-FFPE hematopathology specimens (e.g., peripheral blood smear).