# K120161: Alphapoint Imaging Software

- Pathway: 510(k) (Traditional)
- Applicant: Radlogics, Inc.
- Decided: Apr 13, 2012 after 85 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: 9 generations back to K913770 (1991). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060378: VITREA2 Version 3.8.1, Vital Images, Inc. (2006) Summary page 1.

## Indications for use
The AlphaPoint software is a device that allows review, analysis, and interchange of CT chest images. It is intended for use with CT Chest images to assist medical professionals in image analysis. It is not intended to be the primary interpretation. The software provides segmentation and Hounsfield numerical analysis values which are indicative of various substances (i.e., air, lung, soft tissue, fat, water, transudlate, exudate, blood, muscle and bone). The user can review, verify and correct the results of the system and generate a report of the findings..

Source page: https://510kreport.com/device/K120161
Methodology: https://510kreport.com/methodology