# K081426: Nexstar Liftoff Pet Application Software Suite

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Jun 4, 2008 after 14 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- 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 K930090 (1993). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052640: Gemini Raptor, Philips Medical Systems (Cleveland), Inc. (2005) Summary page 1.

## Indications for use
Software contained in the PET Application Suite process, analyze, display, and quantify medical images/data. The PET and CT images may be registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in: · The evaluation, detection and diagnosis of lesions, disease and organ function such as cancer, cardiovascular disease, and neurological disorders. · The detection, localization, and staging of tumors and diagnosing cancer patients. * Treatment planning and interventional radiology procedures. · The PET Application Suite includes software that provides a quantified analysis of regional cerebral activity from PET images. Cardiac imaging software provides functionality for the quantification of cardiology images and datasets including but not limited to myocardial perfusion for the display of wall motion and quantification of left-ventricular function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium

Source page: https://510kreport.com/device/K081426
Methodology: https://510kreport.com/methodology