Arterys, Inc. radiology AI products

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Radiology AI pricing and total cost of ownership

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FDA-cleared K252539

Tempus Pixel

Arterys, Inc.

Authorized purpose: Multimodality DICOM image management, quantitative analysis, optional cardiovascular MR mapping and flow analysis, and therapy-response lesion tracking for trained clinicians.

Modality: Radiological images; modality varies or is not specified in FDA list
Anatomy: Multi-region
Decision: 2025-09-03

Quantification and segmentation

FDA-cleared K203744

Authorized purpose: Manages, views, processes, stores, transfers, filters, manipulates, and quantitatively measures DICOM and non-DICOM images and data, with optional Cardio AI and Oncology AI support.

Modality: CT/CTA; MRI
Anatomy: Multi-region
Decision: 2022-03-14

Oncology quantification Quantification and segmentation

FDA-cleared K192437

Arterys MICA

Arterys Inc.

Authorized purpose: Support-tool image processing for quantitative cardiovascular assessment and oncologic lesion evaluation, quantification, follow-up, and documentation to aid trained healthcare professionals in diagnosis; the software does not directly generate a diagnosis or potential findings.

Modality: CT/CTA; MRI
Anatomy: Heart and major vessels for Cardio AI; oncology lesion anatomy is not further specified in the FDA statement.
Decision: 2020-03-25

Cardiac imaging Oncology quantification Quantification and segmentation

FDA-cleared K182034

Arterys MICA

Arterys Inc.

Authorized purpose: DICOM/non-DICOM image and data management with optional quantitative cardiac MR and oncology lesion evaluation, quantification, follow-up, and documentation support; the software does not directly generate a diagnosis or potential findings.

Modality: CT/CTA; MRI
Anatomy: Heart and major vessels for the optional Cardio AI module; lung and liver lesions or nodules for the optional Oncology AI module; the base viewer handles broader radiological image data.
Decision: 2018-10-17

Cardiac imaging Oncology quantification Quantification and segmentation

FDA-cleared K173542

Arterys Oncology DL

Arterys Inc.

Authorized purpose: Oncology imaging workflow for viewing, manipulating, 3D visualizing, and comparing images and assessing/documenting morphological changes at diagnostic and therapy follow-up; supports lesion evaluation, quantification, follow-up, and documentation.

Modality: CT/CTA; MRI
Anatomy: Oncologic lesions, with semi-automated segmentation explicitly described for lung nodules and liver lesions.
Decision: 2018-01-25

Lung nodule detection Oncology quantification Quantification and segmentation

FDA-cleared K163253

Arterys Cardio DL

ARTERYS INC.

Authorized purpose: Web-accessible post-processing for viewing and quantifying cardiovascular MR images in DICOM format.

Modality: MRI
Anatomy: Heart/Cardiovascular
Decision: 2017-01-05

Cardiac imaging Quantification and segmentation