510(k) K241717
K241717 is an FDA 510(k) premarket notification submitted by Shandon Diagnostics Limited for the device "E1000 Dx Digital Pathology Solution". The FDA issued a decision of Substantially Equivalent on February 28, 2025. The device falls under product code PSY (Whole Slide Imaging System), a Class II device regulated under 21 CFR 864.3700.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 2025
- Date Received
- June 14, 2024
- Clearance Type
- Traditional
- 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
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).