DeviceClearance

Product code NOT— Hematology

SCANSCOPE XT SYSTEM

Classification name
Microscope, Automated, Image Analysis, Operator Intervention
Device class
Class 2
Regulation
21 CFR 864.1860
Advisory panel
Hematology
Total cleared
13
First cleared
Most recent

FDA classification definition

“Automated microscopic immunohistochemistry image-analysis system to measure cell membrane intensity and pattern with operator intervention.”

— U.S. Food and Drug Administration, device classification record for product code NOT under 21 CFR 864.1860, via openFDA

Market context for product code NOT

FDA has cleared 13 devices under product code NOT between 2003 and 2026, filed by 8 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 NOT

Recent clearances under product code NOT

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