Cleared Traditional

ClearRead CT

K221612 · Riverain Technologies, Inc. · Radiology

Dec 2022

Decision

185d

Days

Class 2

Risk

About This 510(k) Submission

K221612 is an FDA 510(k) clearance for the ClearRead CT, a Lung Computed Tomography System, Computer-aided Detection (Class II — Special Controls, product code OEB), submitted by Riverain Technologies, Inc. (Miamisburg, US). The FDA issued a Cleared decision on December 5, 2022, 185 days after receiving the submission on June 3, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K221612 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 03, 2022
Decision Date	December 05, 2022
Days to Decision	185 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	OEB — Lung Computed Tomography System, Computer-aided Detection
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.2050
Definition	To Assist Radiologists In The Review Of Multi-slice Computed Tomography (msct) Exams Of The Chest And Highlight Potential Nodules That The Radiologist Should Review. A Computer Aided Diagnosis, Lung Computed Tomography System Is A Class 3 Device Under Product Code Nrr.