# K070868: LMS-Lung/Track

- Pathway: 510(k) (Traditional)
- Applicant: Median Technologies
- Decided: May 15, 2007 after 47 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: 5 generations back to K930090 (1993). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040028: CA-1500, R2 Technology, Inc. (2004) Summary page 1.
- K023785: Lung Nodule Assessment and Comparison Option, Philips Medical Systems (Cleveland), Inc. (2003) Summary page 1.
- K024149: Primelung, Accuimage Diagnostics Corp. (2003) Summary page 1.

## Indications for use
LMS-Lung/TRACK is intended to provide the radiologists and other clinicians qualified to interpret CT images the ability to: - visualize chest CT datasets acquired in low or normal dose; - mark and automatically/manually measure characteristics (such as diameter, volume) of lung nodules selected by the user; - compare chest CT scans of the same patient over time for quantification of pulmonary lesion evolution (volume growth and doubling time estimation) - generate automatic reports. LMS-Lung/Track device is designed to be used in diagnostic thoracic CT examinations in adult patients. LMS-Lung/Track is not intended to be used for patients with prior thoracotomy.

Source page: https://510kreport.com/device/K070868
Methodology: https://510kreport.com/methodology