# K023785: Lung Nodule Assessment and Comparison Option

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Feb 10, 2003 after 90 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K930090 (1993). 9 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961464: Select/SP, Elscint, Inc. (1996) Summary page 2.
- K012009: MX8000 Idt CT System, Marconi Medical Systems, Inc. (2001)
- (no number) Image Processing Function on the Mx8000IDT: named in the summary without a submission number

## Most influential descendants
- K162484: Lung Nodule Assessment and Comparison Option (LNA) (2017), 7 descendants of its own
- 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

## Indications for use
The Philips Medical Systems MxView Lung Nodule Assessment and Comparison Option is intended for use as a diagnostic patient-imaging tool. It is intended to provide quantitative information about physician-indicated lung nodules that are identified on high-resolution computed tomography images of the lung. The Lung Nodule Assessment and Comparison Option is used in a workstation (MxView) of a Computed Tomography X-Ray System intended to produce cross-sectional images of the lungs by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.

Source page: https://510kreport.com/device/K023785
Methodology: https://510kreport.com/methodology