# K152949: WebPAX

- Pathway: 510(k) (Traditional)
- Applicant: Heart Imaging Technologies, LLC
- Decided: Aug 17, 2016 after 316 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: 4 generations back to K010938 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042203: Leonardo Syngo Cardiology Workstation, Siemens Medical Solutions USA, Inc. (2004) Summary page 4.
- K051325: Webpax, Model 200, Heart Imaging Technologies, LLC (2005) Summary page 4.

## Indications for use
WebPAX is intended for use in the communication and storage of medical images. WebPAX is also intended for use as a comprehensive solution to view, optimize, and post-process diagnostic medical images as an aid to physicians and other healthcare professionals in the evaluation of digital imaging examinations. Due to special customer requirements based on the imaging modality and clinical focus, WebPAX can be configured with different combinations of clinical applications which are intended to assist the physician in diagnosis or treatment planning. This includes commercially available post-processing techniques such as multi-planar reconstruction (MPR). Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using cleared monitors intended for mammography display. MPR is not intended for mammography use. Not intended for diagnostic use on mobile devices.

Source page: https://510kreport.com/device/K152949
Methodology: https://510kreport.com/methodology