# Arterys Inc.

> Medical device manufacturer record on deviCERTS, compiled from public registries. Arterys Inc. is a medical device manufacturer based in the United States, with 17 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class II; EU Class IIa) as of 15 Nov 2026.

- Canonical page: <https://devicerts.com/manufacturers/arterys-inc>
- Country: United States (from SRN)
- EUDAMED actor status: active
- Role: Manufacturer
- Registrations: EUDAMED, FDA
- EUDAMED SRN: US-MF-000001775
- FDA FEI: 3013306229
- DUNS: 078466835

## Figures

- Devices: 17
- EU certificates: 1
- FDA recalls (matched to the firm by name): 0

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: FDA GUDID 9, FDA 510(k) 7, EUDAMED 1
- Device classes: FDA Class II 16, EU Class IIa 1
- EMDN [Z11 Bioimaging and radiotherapy instruments](https://devicerts.com/categories/emdn/Z11): 1 devices

## Sites and related companies

- Authorised representative: [Emergo Europe B.V.](https://devicerts.com/representatives/emergo-europe-bv-nl-ar-000000116) (Netherlands)

## Devices

The first 17 of 17, in the order of the canonical page, which lists them all.

- [Arterys Oncology DL AOM4](https://devicerts.com/devices/arterys-oncology-dl-aom4) · Class II · GUDID · status: Withdrawn
- [Arterys Cardio DL CVM2](https://devicerts.com/devices/arterys-cardio-dl-cvm2-3acb6b4b) · Class II · GUDID · status: Withdrawn
- [Arterys MICA AMM7](https://devicerts.com/devices/arterys-mica-amm7) · Class II · GUDID · status: Active
- [Tempus Pixel AMM7](https://devicerts.com/devices/tempus-pixel-amm7-d20ea9a3) · Class II · GUDID · status: Listed
- [Arterys Cardio DL CVM2](https://devicerts.com/devices/arterys-cardio-dl-cvm2) · Class II · GUDID · status: Withdrawn
- [Arterys Viewer AVM3](https://devicerts.com/devices/arterys-viewer-avm3-ff336dc2) · Class II · GUDID · status: Withdrawn
- [Arterys MICA AMM5](https://devicerts.com/devices/arterys-mica-amm5) · Class II · GUDID · status: Withdrawn
- [Arterys MICA AMM6](https://devicerts.com/devices/arterys-mica-amm6) · Class II · GUDID · status: Withdrawn
- [Arterys Viewer AVM3](https://devicerts.com/devices/arterys-viewer-avm3) · Class II · GUDID · status: Withdrawn
- [Arterys MICA](https://devicerts.com/devices/arterys-mica-llz) · ref K182034 · Class II · 510(k) · status: Active · decision 2018-10-17
- [Arterys Cardio DL](https://devicerts.com/devices/arterys-cardio-dl-llz) · ref K163253 · Class II · 510(k) · status: Active · decision 2017-01-05
- [Arterys Viewer](https://devicerts.com/devices/arterys-viewer-llz) · ref K171544 · Class II · 510(k) · status: Active · decision 2017-07-18
- [Arterys MICA](https://devicerts.com/devices/arterys-mica-qih-k203744) · ref K203744 · Class II · 510(k) · status: Active · decision 2022-03-14
- [Arterys MICA](https://devicerts.com/devices/arterys-mica-qih) · ref K192437 · Class II · 510(k) · status: Active · decision 2020-03-25
- [Arterys Oncology DL](https://devicerts.com/devices/arterys-oncology-dl-llz) · ref K173542 · Class II · 510(k) · status: Active · decision 2018-01-25
- [Arterys Software v2.0](https://devicerts.com/devices/arterys-software-v2-0-llz) · ref K162513 · Class II · 510(k) · status: Active · decision 2016-10-28
- [Tempus Pixel](https://devicerts.com/devices/tempus-pixel-amm7) · ref AMM7 · Class IIa · EUDAMED · status: Active

## EU certificates

- MDR 730904 · Quality management system · MDR · notified body BSI Group The Netherlands B.V. · issued 2026-03-20 · expires 2031-04-14 · status: reissued

## Source and citation

- Cite as: Arterys Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/arterys-inc (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA registration and listing](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm)
- EUDAMED record synced: 2026-11-07
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-15
- JSON: <https://devicerts.com/manufacturers/arterys-inc.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/arterys-inc
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.