DeviceClearance

Product code PSY— Pathology

Philips IntelliSite Pathology Solution

Classification name
Whole Slide Imaging System
Device class
Class 2
Regulation
21 CFR 864.3700
Advisory panel
Pathology
Total cleared
23
First cleared
Most recent

FDA classification 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).”

— U.S. Food and Drug Administration, device classification record for product code PSY under 21 CFR 864.3700, via openFDA

Market context for product code PSY

FDA has cleared 23 devices under product code PSY between 2017 and 2026, filed by 11 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PSY

Recent clearances under product code PSY

Data sourced from openFDA. This site is unofficial and independent of the FDA.