Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015478020

FEI Number

3015478020

Entity Name

OPTELLUM LTD

City/State/Country

Oxford Oxfordshire, GB

Establishment Address

Five Kings Meadow, Osney Mead, Oxford Oxfordshire OX2 0DP, GB

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Optellum Ltd (Owner Number: 10060418)

Owner / Operator Contact Address

Five Kings Meadow, Osney Mead, Oxford, GB-OXF OX2 0DP, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K202300

PMA Number

N/A

All Registered Proprietary Names

Optellum software Optellum Virtual Nodule Clinic Optellum platform

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
POK	Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer	Radiology	Class 2	892.2060	2021-03-31

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Optellum Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K251769	Precision Medical Ventures, Inc. Dba Revealdx	RevealAI-Lung	2026-01-30

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015478020. Last updated year: 2026. Please use registration number 3015478020 when referencing this establishment in official correspondence.