# K192372: ASCEND Image Viewer

- Pathway: 510(k) (Traditional)
- Applicant: Ascend Hit
- Decided: Feb 14, 2020 after 168 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: 14 generations back to K935595 (1995). 111 ancestors in all.
No later device cites it as a predicate yet.
0 of 112 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132544: Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-Arena, Tomtec Imaging Systems GmbH (2013) Summary page 4.

## Indications for use
ASCEND Image Viewer is a software-only medical device intended for use by trained clinicians to display medical images. ASCEND Image Viewer provides viewing of and measurements on echocardiograms from compatible ultrasound systems that support transthoracic echocardiogram, transesophageal echocardiogram, stress echocardiogram, cath, and vascular study types. ASCEND Image Viewer is for prescription use only.

Source page: https://510kreport.com/device/K192372
Methodology: https://510kreport.com/methodology