# K033412: Mediclung, Release 1

- Pathway: 510(k) (Traditional)
- Applicant: Medicsight
- Decided: Dec 30, 2003 after 64 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.
136 later devices descend from it; 1 cites it directly.
1 of 141 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) Summary page 1.
- K022013: Lungcare CT Software Package, Siemens Medical Solutions USA, Inc. (2002) Summary page 1.

## Most influential descendants
- K041807: Lung Car 1.1 (2004), 135 descendants of its own
- K061214: Aquariusaps Server (2006), 134 descendants of its own
- K112020: Syngo.CT Vascular Analysis (2011), 99 descendants of its own
- K123920: Syngo.Via (2013), 63 descendants of its own
- K150843: syngo®.via (version VB10A) (2015), 46 descendants of its own

## Indications for use
MedicLung I is a PC-based, stand-alone, non-invasive, image analysis software application for the display and visualization of 20 and 3D medical image data of the lung derived from CT scans, for the purpose of assisting radiologists and other clinicians in the evaluation of lung lesions (e.g. nodules). The software provides functionality for the user to extract the region of interest (ROI) either manually using a drawing tool, or "semi-automatically" through the user selecting either a single or double seed point followed by interactive fine-tuning the boundaries of the ROL. MedicLung I provides quantative information for measurement of lesion volume and other measured characteristics over time allowing the user to review and track any changes in the physician-indicated nodules or lesions.

Source page: https://510kreport.com/device/K033412
Methodology: https://510kreport.com/methodology