DeviceClearance

Product code OEO— Hematology

SCANSCOPE XT SYSTEM

Classification name
Automated Digital Image Manual Interpretation Microscope
Device class
Class 2
Regulation
21 CFR 864.1860
Advisory panel
Hematology
Total cleared
6
First cleared
Most recent

FDA classification definition

“The ihc her2 manual read of a digital slide application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of her2/neu (c-erbb-2) in formalin-fixed, paraffin-embedded normal and neoplastic tissue immunohistochemically stained for her-2 receptors, using microscopy images displayed on a computer monitor. Her-2 results are indicated for use as an aid in the management, prognosis and prediction of therapy outcomes in breast cancer.”

— U.S. Food and Drug Administration, device classification record for product code OEO under 21 CFR 864.1860, via openFDA

Market context for product code OEO

FDA has cleared 6 devices under product code OEO between 2007 and 2015, filed by 5 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 OEO

Recent clearances under product code OEO

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