510(k) K213037— IDx-DR v2.3

Substantially Equivalent

Digital Diagnostics, Inc.

Clearance details

Applicant: Digital Diagnostics, Inc.
Product code: Code PIB
Advisory panel: Ophthalmic
Date received: 2021-09-21
Decision date: 2022-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Coralville, IA, US

Download summary PDF View on FDA.gov ↗

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