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
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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.

View all Riverain Technologies, LLC devices

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
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 107d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

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

All 16
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