PSY · Class II — Moderate Risk (510(k) clearance required) · Pathology · 21 CFR 864.3700
Classification
FDA Product Code
PSY
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 864.3700
Review panel
PA
Medical specialty
Pathology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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).