# K161201: ClearRead CT

- Pathway: 510(k) (Traditional)
- Applicant: Riverain Technologies, LLC
- Decided: Sep 9, 2016 after 134 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: 10 generations back to K913770 (1991). 144 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 150 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143196: syngo.CT Lung CAD, Siemens AG Medical Solutions (2015) Summary page 4.
- K093621: Syngo.Pet&CT Oncology, Siemens Medical Solutions USA, Inc. (2010) Summary page 4.
- K092363: Softview, Model 2.01, Riverain Medical Group (2010) Summary page 5.

## Most influential descendants
- K192880: InferRead Lung CT.AI (2020), 1 descendant of its own
- K254075: Synapse Lung Nodule AI (2026), 0 descendants of its own
- K240554: InferRead Lung CT.AI (2025), 0 descendants of its own
- K242919: V5med Lung AI (2025), 0 descendants of its own
- K221612: ClearRead CT (2022), 0 descendants of its own

## Indications for use
ClearRead CT™ is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during review of CT examinations of the chest on an asymptomatic population. The ClearRead CT requires both lungs be in the field of view. ClearRead CT provides adjunctive information and is not intended to be used without the original CT series.

Source page: https://510kreport.com/device/K161201
Methodology: https://510kreport.com/methodology