PSY
23 FDA 510(k) clearances · Product code
237 daysmedian time to decision
288 days90th percentile
23clearances measured
FDA profile
- Official device name
- Whole Slide Imaging System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.3700
- Medical specialty
- Pathology
- FDA definition
- 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).
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Every clearance here is in the API, with alerts when new ones post.