# K202990: NinesMeasure

- Pathway: 510(k) (Traditional)
- Applicant: Nines, Inc.
- Decided: Feb 25, 2021 after 148 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: 9 generations back to K913770 (1991). 35 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162484: Lung Nodule Assessment and Comparison Option (LNA), Philips Medical Systems Nederland B.V. (2017) Summary page 4.

## Most influential descendants
- K240740: qCT LN Quant (2024), 0 descendants of its own

## Indications for use
NinesMeasure is a semi-automatic tool indicated for use by trained radiologists to aid in the analysis and review of adult thoracic CT images. NinesMeasure provides quantitative information about pulmonary nodule size on a single study or over the time course of several thoracic studies by providing long and short axis diameter measurements in the axial plane. Based on analysis of DICOM images and provided input from a radiologist, indicating the location of the pulmonary nodule, the device uses artificial intelligence algorithms to automatically perform the measurements, and allows the axial measurements to be displayed and reviewed. NinesMeasure is limited for use on solid pulmonary nodules. The device is intended to be used as a measurement tool by a trained radiologist and is limited to analysis of imaging data and should not be used in-lieu of full patient evaluation or relied upon to make or confirm a diagnosis. The device does not alter the original medical image.

Source page: https://510kreport.com/device/K202990
Methodology: https://510kreport.com/methodology