# K161959: ClearView cCAD

- Pathway: 510(k) (Traditional)
- Applicant: Clearview Diagnostics, Inc.
- Decided: Dec 28, 2016 after 163 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K913770 (1991). 12 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050846: B-Cad System, Version 1.0, The Medipattern Corporation (2005) Summary page 4.

## Most influential descendants
- K190442: Koios DS for Breast (2019), 12 descendants of its own
- K201555: EchoGo Pro (2020), 6 descendants of its own
- K212616: Koios DS (2021), 4 descendants of its own
- K242342: Fetal EchoScan (2024), 2 descendants of its own
- K251071: Fetal EchoScan (v1.1) (2025), 1 descendant of its own

## Recalls of this device
- Dec 31, 2019 · Class II · Z-0820-2020: Affected software product versions were found during internal audit to have been marketed for sale without sufficient documentation pertaining to certain required quality procedures.

## Indications for use
ClearView cCAD is a software application designed to assist skilled physicians in analyzing breast ultrasound images. ClearView cCAD automatically classifies shape and orientation characteristics of user-selected regions of interest (ROIs). The software allows the user to annotate, tag, measure, and automatically record and/or store selected views. The software also automatically generates reports from user inputs annotated during the image analysis process as well as the automatically generated characteristics. The output of this system will be a DICOM compatible (e.g. grayscale softcopy presentation state (GSPS)) and/or PDF report that can be sent along with the original image to standard film or paper printers or sent electronically to an intranet webserver or other DICOM compatible device. cCAD includes options to annotate and describe the image based on the ACR BI-RADS® Breast Imaging Atlas. In addition, the report form has been designed to support compliance with the ACR BI-RADS ® Ultrasound Lexicon Classification Form. When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. Patient management decision should not be made solely on the results of the cCAD analysis. The ultrasound images displayed on cCAD must not be used for primary diagnostic interpretation.

Source page: https://510kreport.com/device/K161959
Methodology: https://510kreport.com/methodology