# K221612: ClearRead CT

- Pathway: 510(k) (Traditional)
- Applicant: Riverain Technologies, Inc.
- Decided: Dec 5, 2022 after 185 days
- Product code: OEB (Lung Computed Tomography System, Computer-Aided Detection)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K913770 (1991). 164 ancestors in all.
No later device cites it as a predicate yet.
0 of 165 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161201: ClearRead CT, Riverain Technologies, LLC (2016) Summary page 5.
- K162484: Lung Nodule Assessment and Comparison Option (LNA), Philips Medical Systems Nederland B.V. (2017) Summary page 5.

## Indications for use
ClearRead CT is comprised of computer-assisted reading tools designed to aid the radiologist in the detection and characterization of pulmonary nodules during the review of screening and surveillance (low-dose) CT examinations of the chest on a non-oncological patient population. ClearRead CT requires both lungs be in the field of view and is not intended for monitoring patients undergoing therapy for lung cancer or limited field of view CT scans. ClearRead CT provides adjunctive information and is not intended to be used without the original CT series.

Source page: https://510kreport.com/device/K221612
Methodology: https://510kreport.com/methodology