Cleared Traditional

K161201 - ClearRead CT

K161201 is an FDA 510(k) clearance for ClearRead CT, manufactured by Riverain Technologies, LLC. The device is a Class 2 Radiology device with product code OEB cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K161201 · Riverain Technologies, LLC · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
134d
Days
Class 2
Risk

K161201 is an FDA 510(k) clearance for the ClearRead CT. Classified as Lung Computed Tomography System, Computer-aided Detection (product code OEB), Class II - Special Controls.

Submitted by Riverain Technologies, LLC (Miamisburg, US). The FDA issued a Cleared decision on September 9, 2016 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K161201

510(k) Number K161201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2016
Decision Date September 09, 2016
Days to Decision 134 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 107d · This submission: 134d
Pathway characteristics
Predicate-based equivalence.

OEB Device Classification - Class 2, Special Controls

Product Code OEB Lung Computed Tomography System, Computer-aided Detection
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Radiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02440139 Completed Interventional

Evaluation of Computer-Aided Lung Nodule Detection Software in Thoracic CT for Riverain Technologies LLC

Computer-Aided System for the Improvement of Nodule Detection and Characterization in Thoracic CT Based on a Novel Vessel Suppressed CT Volume

12
Patients (actual)
1
Site
Diagnostic
Purpose
Double blind
Masking
Condition studied Lung Cancer
Study design Parallel
Eligibility All sexes · 55 Years+
Principal investigator Matthew T Freedman, M.D.
Sponsor Virginia Polytechnic Institute and State University
Started 2015-04-01 → Primary completion 2017-09-01 → Completed 2018-03-01
Primary outcome
Comparing the Detection Accuracy, Sensitivity, and Specificity of Clinically Actionable Lung Nodules
Secondary outcome
Average Reading Time Per Case
View full study on ClinicalTrials.gov

Regulatory Peers - OEB Lung Computed Tomography System, Computer-aided Detection

All 19
Devices cleared under the same product code (OEB) and FDA review panel - the closest regulatory comparables to K161201.
Veolity
K201501 · Mevis Medical Solutions AG · Feb 2021
InferRead Lung CT.AI
K192880 · Beijing Infervision Technology Co., Ltd. · Jul 2020
syngo.CT Lung CAD
K193216 · Siemens Medi Cal Solutions, Inc. · Mar 2020
syngo.CT Lung CAD
K143196 · Siemens AG Medical Solutions · May 2015
IMAGECHECKER CT CAD SOFTWARE SYSTEM
K043617 · Hologic, Inc. · Dec 2007
SYNGO LUNG CAD
K063877 · Siemens Medical Solutions USA, Inc. · Oct 2006
K161201 · ClearRead CT
Download PDF FDA Summary Riverain Technologies…