Arterys, Inc.
Arterys, Inc. appears in FDA public data with 0 recalls, 8 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Sep 3, 2025.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 8
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| 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 |