FDA 510(k) Application Details - K202300

Device Classification Name	More FDA Info for this Device
510(K) Number	K202300
Device Name	Optellum Virtual Nodule Clinic, Optellum software, Optellum platform
Applicant	Optellum Ltd Oxford Centre for Innovation, New Road Oxford OX1 1BY GB Other 510(k) Applications for this Company
Contact	David Arrowsmith Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	POK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/13/2020
Decision Date	03/05/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review