# K022013: Lungcare CT Software Package

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jul 16, 2002 after 26 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: 3 generations back to K913770 (1991). 3 ancestors in all.
379 later devices descend from it; 6 cite it directly.
1 of 383 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013381: Advanced Lung Analysis-1, General Electric Co. (2001)

## Most influential descendants
- K033374: Lungcare CT Software Package with Extended Functionality (2003), 295 descendants of its own
- K063762: Syngo Circulation Software Package with Extended Functionality (2007), 263 descendants of its own
- K041484: Undecided (2004), 222 descendants of its own
- K053301: Cedara I-Response Cedara Pet/CT (2006), 221 descendants of its own
- K042694: Advanced Lung Analysis II (2004), 207 descendants of its own

## Indications for use
Lung CARE CT is a self-contained image analysis software package for evaluating CT volume data sets. Combining enhanced commercially available digital image processing tools with optimized workflow and reporting tools, the software is designed to support the physician in confirming the presence or absence of physician-identified lung lesions (eg. nodules) in addition to evaluation, documentation and follow-up of any such lesions using standard or low-dose spiral CT scanning. This evaluation tool allows for volumetric analysis of pulmonary nodule or lesion size over time, helping the Physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue unambiguously, with respect to their size, dimensions, shape and position.

Source page: https://510kreport.com/device/K022013
Methodology: https://510kreport.com/methodology