# Arterys, Inc.

- Location (FDA's records): San Francisco, CA
- FDA decisions: 8 (2016–2025): 8 510(k) clearances
- Product codes: LLZ (5), QIH (3)
- 510(k) review time since 2016: median 62 days, against 107 for FDA's reviews in the same codes and years (6 of 8 faster)
- Predicates its devices cite: 12 (7 its own); citations of its devices by later devices: 9 (7 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medis Medical Imaging Systems BV: 2 (https://510kreport.com/company/medis-medical-imaging-systems)
- Morpheus Imaging, Inc.: 1 (https://510kreport.com/company/morpheus-imaging)
- Healthmyne, Inc.: 1 (https://510kreport.com/company/healthmyne)
- Siemens Medical Solutions: 1 (https://510kreport.com/company/siemens-medical-solutions)

## Firms that cite its devices most
- Ezra Ai, Inc.: 1 (https://510kreport.com/company/ezra-ai)
- Ever Fortune.Ai, Co., Ltd.: 1 (https://510kreport.com/company/ever-fortune-ai)

## Its most-cited devices
- K171544: Arterys Viewer (2017), cited by 2
- K173542: Arterys Oncology DL (2018), cited by 2
- K162513: Arterys Software v2.0 (2016), cited by 1
- K203744: Arterys MICA (2022), cited by 1
- K182034: Arterys MICA (2018), cited by 1
- K163253: Arterys Cardio DL (2017), cited by 1

## Recent decisions
- K252539: Tempus Pixel (Sep 3, 2025)
- K203744: Arterys MICA (Mar 14, 2022)
- K192437: Arterys MICA (Mar 25, 2020)
- K182034: Arterys MICA (Oct 17, 2018)
- K173542: Arterys Oncology DL (Jan 25, 2018)
- K171544: Arterys Viewer (Jul 18, 2017)
- K163253: Arterys Cardio DL (Jan 5, 2017)
- K162513: Arterys Software v2.0 (Oct 28, 2016)

Source page: https://510kreport.com/company/arterys