# K252539: Tempus Pixel

- Pathway: 510(k) (Special)
- Applicant: Arterys, Inc.
- Decided: Sep 3, 2025 after 22 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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 K913770 (1991). 119 ancestors in all.
No later device cites it as a predicate yet.
0 of 120 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203744: Arterys MICA, Arterys, Inc. (2022) Summary page 5.

## Indications for use
Tempus Pixel software is a medical diagnostic application that displays, processes, stores, and transfers DICOM and non-DICOM medical data. It provides the capability to store images and patient information, and perform filtering, digital manipulation, and quantitative measurements. The client software is designed to run on standard personal and business computers and on monitors/screens that meet appropriate technical specification for image diagnosis. Tempus Pixel includes an optional Pixel Cardio module which is used to analyze the heart and its major vessels using multi-slice, multi-phase, and velocity-encoded cardiovascular magnetic resonance (MR) images. It provides clinically relevant and reproducible, quantitative data, and has been tested and validated on MR images acquired from both 1.5T and 3.0T MR Scanners. Tempus Pixel includes an optional Pixel Therapy Response Evaluation module which provides analytical tools to help the user assess and document changes in morphological activity at diagnostic and therapy follow-up examinations. It is a tool used to support the oncological workflow by helping the user confirm the absence or presence of lesions, including evaluation, quantification, follow-up, and documentation of any such lesions. Tempus Pixel software is intended to be used as a support tool by trained healthcare professionals to aid in diagnosis. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings.

Source page: https://510kreport.com/device/K252539
Methodology: https://510kreport.com/methodology