NOT

Microscope, Automated, Image Analysis, Operator Intervention

Product code

NOT

Device name

Microscope, Automated, Image Analysis, Operator Intervention

Device class

Class 2

21 CFR

21 CFR 864.1860

Medical specialty

Hematology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

13 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-07-02.

1 summaries are archived here for direct download.