Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Optellum, Ltd.. It received FDA 510(k) clearance on 2021-03-05 under 510(k) 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. The listed applicant is Optellum, Ltd.. The 510(k) number is K202300.

When did Optellum Virtual Nodule Clinic, Optellum software, Optellum platform receive FDA 510(k) clearance?

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

Who is the listed applicant for Optellum Virtual Nodule Clinic, Optellum software, Optellum platform?

The FDA 510(k) record lists Optellum, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06638398Biomarker Platform (Virtual Nodule Clinic) for the Management of Indeterminate Pulmonary NodulesACTIVE_NOT_RECRUITINGNCT02603640" Virtual Brain "-Based Interpretation of Electrophysiological Signals in EpilepsyCOMPLETEDNCT03636230Virtual E-health System for PacemakersACTIVE_NOT_RECRUITINGNCT04544904The Technology, Exercise Programming, and Activity Prescription for Enhanced Mobility (TEAM) StudyCOMPLETEDNCT06647576Exploring Neurosphere's Remote Monitoring and Virtual Clinic Features in Improve Quality of Life and Reduce CostsCOMPLETEDNCT07448103Hospital and Home Rehabilitation Based on Social Care Robotics and Artificial Intelligence for Pediatric PatientsRECRUITING

Related Devices (Code: POK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253884Koios DS (3.8)Koios Medical, Inc.K261519Sonio SuspectSonioK254161Automated Aortic Stenosis Software (AutoAS)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLCK251769RevealAI-LungPrecision Medical Ventures, Inc. Dba RevealdxK252294Fetal EchoScan (v1.2)BrightheartK250221StrokeSENS ASPECTS Software ApplicationCircle Cardiovascular Imaging, Inc.

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.

↑