# K162484: Lung Nodule Assessment and Comparison Option (LNA)

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Feb 23, 2017 after 169 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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: 8 generations back to K913770 (1991). 34 ancestors in all.
7 later devices descend from it; 6 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151283: Lung Analysis Software, Vital Images, Inc. (2015) Summary page 5.
- K023785: Lung Nodule Assessment and Comparison Option, Philips Medical Systems (Cleveland), Inc. (2003) Summary page 5.

## Most influential descendants
- K202990: NinesMeasure (2021), 1 descendant of its own
- K193220: Aview LCS (2020), 1 descendant of its own
- K240554: InferRead Lung CT.AI (2025), 0 descendants of its own
- K240740: qCT LN Quant (2024), 0 descendants of its own
- K221612: ClearRead CT (2022), 0 descendants of its own

## Indications for use
The Lung Nodule Assessment and Comparison Option is intended for use as a diagnostic patient-imaging tool. It is intended for the review and analysis of thoracic CT images, providing quantitative and characterizing information about nodules in the lung in a single study, or over the time course of several thoracic studies. Characterizations include diameter, volume and volume over time. The system automatically performs the measurements, allowing lung nodules and measurements to be displayed.

Source page: https://510kreport.com/device/K162484
Methodology: https://510kreport.com/methodology