# K162513: Arterys Software v2.0

- Pathway: 510(k) (Traditional)
- Applicant: Arterys, Inc.
- Decided: Oct 28, 2016 after 50 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: 6 generations back to K940172 (1994). 24 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133937: Heartscan Software, Morpheus Imaging, Inc. (2014) Summary page 4.
- K140587: MR-CT Vva, Medis Medical Imaging Systems BV (2015) Summary page 4.

## Most influential descendants
- K163253: Arterys Cardio DL (2017), 4 descendants of its own
- K182034: Arterys MICA (2018), 3 descendants of its own
- K192437: Arterys MICA (2020), 2 descendants of its own
- K203744: Arterys MICA (2022), 1 descendant of its own
- K252539: Tempus Pixel (2025), 0 descendants of its own

## Indications for use
The Arterys Software consists of software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. Arterys Software specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images. It provides clinically-relevant and reproducible, quantitative data, and it has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners. The data produced by the Arterys Software is intended to be used to support qualified cardiologist, radiologist, or other licensed professional healthcare practitioners for clinical decision-making. It is a support tool that provides relevant clinical data as a resource to the clinician and is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient.

Source page: https://510kreport.com/device/K162513
Methodology: https://510kreport.com/methodology