QTW

Digital Amsler Grid

Product code: QTW
Device name: Digital Amsler Grid
Device class: Class 1
21 CFR: 21 CFR 886.1330
Medical specialty: Ophthalmic
Marketing pathway: 510(K) Exempt
510(k) clearances (all years, FDA): 1 (all years; only the last 3 years are listed here)

FDA classification definition

A Digital Amsler grid is intended as an aid in detection of central visual irregularities caused by changes in the visual pathway in patients.

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

Official FDA classification page: QTW

Classification and pathway per current FDA publications. Data from openFDA (CC0).