Optellum Virtual Nodule Clinic, Optellum software, Optellum platform— 510(k) K202300

Name: FDA 510(k) clearance K202300
Creator: U.S. Food and Drug Administration
Published: 2021-03-05

Substantially Equivalent

Optellum, Ltd.

FDA 510(k) clearance K202300 for Optellum Virtual Nodule Clinic, Optellum software, Optellum platform, Substantially Equivalent on 2021-03-05. Applicant: Optellum, Ltd.. Device class: 2.

Clearance details

Applicant: Optellum, Ltd.
Product code: Code POK
Device class: Class 2
Regulation: 21 CFR 892.2060
Advisory panel: Radiology
Date received: 2020-08-13
Decision date: 2021-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxford, GB

Download summary PDF View on FDA.gov ↗

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