# K223133: VisiRad XR

- Pathway: 510(k) (Traditional)
- Applicant: Imidex, Inc.
- Decided: Aug 3, 2023 after 304 days
- Product code: MYN (Analyzer, Medical Image)
- Device class: 2
- Regulation: 21 CFR 892.2070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to P000041 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201560: Auto Lung Nodule Detection, Samsung Electronics Co., Ltd. (2021) Summary page 4.

## Indications for use
VisiRad XR is a computer-aided detection (CADe) device intended to identify and mark regions of interest that may be suspicious for lung nodules and masses on chest radiographs. It identifies features associated with pulmonary nodules and masses from 6-60mm in size. Detection of suspicious findings by VisiRad XR is intended as an aid only after the physician has performed an initial interpretation; it is not intended to replace the review by a qualified radiologist and is not intended to be used for triage or to make or confirm a diagnosis. The intended patient population for VisiRad XR consists of patients >21 years of age on whom chest radiographs have been acquired in an outpatient or emergency department setting.

Source page: https://510kreport.com/device/K223133
Methodology: https://510kreport.com/methodology