# K033374: Lungcare CT Software Package with Extended Functionality

- Pathway: 510(k) (Special)
- Applicant: Siemens AG Medical Solutions
- Decided: Nov 6, 2003 after 15 days
- Product code: OEB (Lung Computed Tomography System, Computer-Aided Detection)
- 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: 4 generations back to K913770 (1991). 4 ancestors in all.
295 later devices descend from it; 5 cite it directly.
1 of 300 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022013: Lungcare CT Software Package, Siemens Medical Solutions USA, Inc. (2002)

## Most influential descendants
- 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
- K063324: Pet Vcar (2007), 204 descendants of its own
- K071950: Syngo Trued (2007), 201 descendants of its own

## Indications for use
LungCARE CT is a self-contained image analysis software package for evaluating CT volume data sets. Combining enhanced commercially available digital image processing tools with an 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 foflow-up of any such lesions using standard or low-dose spiral CT scanning. The LungCare CT Software Package with extended functionality contains modifications which support the user with a special workflow based on automated segmentation for the visual identification of possible lesions (Nodule enhanced Viewing). This visualization 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 having determined their size, dimensions, shape and position.

Source page: https://510kreport.com/device/K033374
Methodology: https://510kreport.com/methodology