FDA-cleared K163253
Arterys Cardio DL
ARTERYS INC.
The device is intended to visualize and quantify MRI data in DICOM format.
- Modality
- MRI
- Anatomy
- Vascular
- Decision
- 2017-01-05
Vendor
ARTERYS INC.
6 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K173542
Arterys Oncology DL
Arterys Inc.
Image analysis/processing for Vascular using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Vascular
- Decision
- 2018-01-25
FDA-cleared K182034
Arterys MICA
Arterys Inc.
Image analysis/processing for Vascular using Mammography/DBT.
- Modality
- Mammography/DBT
- Anatomy
- Vascular
- Decision
- 2018-10-17
FDA-cleared K192437
Arterys MICA
Arterys Inc.
Image analysis/processing for Vascular using Mammography/DBT.
- Modality
- Mammography/DBT
- Anatomy
- Vascular
- Decision
- 2020-03-25
FDA-cleared K203744
Arterys MICA
Arterys Inc.
Image analysis/processing for Vascular using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Vascular
- Decision
- 2022-03-14
FDA-cleared K252539
Tempus Pixel
Arterys, Inc.
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2025-09-03