Cleared Traditional

K221612 - ClearRead CT

K221612 is an FDA 510(k) clearance for ClearRead CT, manufactured by Riverain Technologies, Inc.. The device is a Class 2 Radiology device with product code OEB cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K221612 · Riverain Technologies, Inc. · Radiology device
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Dec 2022
Decision
185d
Days
Class 2
Risk

K221612 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, Inc. (Miamisburg, US). The FDA issued a Cleared decision on December 5, 2022 after a review of 185 days - an extended review cycle.

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, Inc. devices

FDA 510(k) Submission Details - K221612

510(k) Number K221612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 107d · This submission: 185d
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 15
Devices cleared under the same product code (OEB) and FDA review panel - the closest regulatory comparables to K221612.
V5med Lung AI
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syngo.CT Lung CAD (Version VD30)
K231157 · Siemens Healthcare GmbH · Jul 2023
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syngo.CT Lung CAD
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Veolity
K201501 · Mevis Medical Solutions AG · Feb 2021
InferRead Lung CT.AI
K192880 · Beijing Infervision Technology Co., Ltd. · Jul 2020