# K201501: Veolity

- Pathway: 510(k) (Traditional)
- Applicant: MeVis Medical Solutions AG
- Decided: Feb 23, 2021 after 263 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: 9 generations back to K913770 (1991). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043617: Imagechecker CT Cad Software System, Hologic, Inc. (2007) Summary page 5.
- K023003: Imagechecker-CT Workstation, R2 Technology, Inc. (2002) Summary page 5.
- K040028: CA-1500, R2 Technology, Inc. (2004) Summary page 5.
- K162484: Lung Nodule Assessment and Comparison Option (LNA), Philips Medical Systems Nederland B.V. (2017) Summary page 5.

## Indications for use
Veolity is intended to: display a composite view of 2D cross-sections, and 3D volumes of chest CT images, allow comparison between new and previous acquisitions as well as abnormal thoracic regions of interest, such as pulmonary nodules, provide Computer-Aided Detection (“CAD”) findings, which assist radiologists in the detection of solid pulmonary nodules between 4-30 mm in size in CT images with or without intravenous contrast. CAD is intended to be used as an adjunct, alerting the radiologist — after his or her initial reading of the scan — to regions of interest that may have been initially overlooked. The system can be used with any combination of these features. Enabling/disabling is handled via licensing or configuration options. Intended Patient Population: Veolity is an imaging software including computer assisted reading tools for reviewing CT examinations of the chest on an asymptomatic population. Intended Conditions of Use: As a software-only product, Veolity does not come into direct contact or indirect contact with patients, and it is neither a sterile device nor an in vitro diagnostic device. Additionally, the environmental and location requirements as defined for the hardware running Veolity apply. The software does not alter these requirements. Intended User Profile: Veolity is intended to be used by medical professionals (e.g., radiologists) with adequate training.

Source page: https://510kreport.com/device/K201501
Methodology: https://510kreport.com/methodology