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FDA 510(k)

Optellum Virtual Nodule Clinic, Optellum software, Optellum platform

K-Number: K202300 · 2021-03-05

ApplicantOptellum, Ltd.
Decision Date2021-03-05
Product CodePOK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Optellum Virtual Nodule Clinic, Optellum software, Optellum platform is a medical device manufactured by Optellum, Ltd.. It received FDA 510(k) clearance on 2021-03-05 under approval number K202300. The device is classified under product code POK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Optellum Virtual Nodule Clinic, Optellum software, Optellum platform?

Optellum Virtual Nodule Clinic, Optellum software, Optellum platform is a medical device that received FDA 510(k) clearance on 2021-03-05. It is manufactured by Optellum, Ltd.. The 510(k) number is K202300.

When was Optellum Virtual Nodule Clinic, Optellum software, Optellum platform approved by the FDA?

Optellum Virtual Nodule Clinic, Optellum software, Optellum platform received FDA 510(k) clearance on 2021-03-05, under approval number K202300.

What company makes Optellum Virtual Nodule Clinic, Optellum software, Optellum platform?

Optellum Virtual Nodule Clinic, Optellum software, Optellum platform is manufactured by Optellum, Ltd..

What is the FDA product code for Optellum Virtual Nodule Clinic, Optellum software, Optellum platform?

The FDA product code for Optellum Virtual Nodule Clinic, Optellum software, Optellum platform is POK.

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Related PubMed Literature

PMID: 41790854 A Substance Use Disorder Virtual Treatment and Research Platform: A Proof of Concept. IEEE pulse (2025) PMID: 40619298 Software-based finger joint range of motion analysis: Current concepts, considerations, and challenges. Journal of hand therapy : official journal of the American Society of Hand Therapists (2025)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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