Arterys, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Arterys, Inc.” (first 2016, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 62 days. Since 2017 the median was 70 days, against 131 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 50 |
| 2017 | 2 | 50 |
| 2018 | 2 | 74 |
| 2019 | 0 | — |
| 2020 | 1 | 201 |
| 2021 | 0 | — |
| 2022 | 1 | 447 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 22 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Arterys, Inc. took a median 70 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 131 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 5 | 5 |
| QIH | Automated Radiological Image Processing Software | 3 | 3 |
Review panels
- Radiology (8)
Most recent Arterys, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252539 | Tempus Pixel | QIH | 2025-09-03 | 22 |
| K203744 | Arterys MICA | QIH | 2022-03-14 | 447 |
| K192437 | Arterys MICA | QIH | 2020-03-25 | 201 |
| K182034 | Arterys MICA | LLZ | 2018-10-17 | 79 |
| K173542 | Arterys Oncology DL | LLZ | 2018-01-25 | 70 |
| K171544 | Arterys Viewer | LLZ | 2017-07-18 | 53 |
| K163253 | Arterys Cardio DL | LLZ | 2017-01-05 | 48 |
| K162513 | Arterys Software v2.0 | LLZ | 2016-10-28 | 50 |
Recalls
openFDA lists no recalls under a recalling firm named Arterys, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Arterys, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Arterys, Inc.” (first 2016, latest 2025), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Arterys, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Arterys, Inc. is 62 days. Since 2017: 70 days, versus 131 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Arterys, Inc.?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 5); QIH (Automated Radiological Image Processing Software, 3).
Next steps
- See all 8 Arterys, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Arterys, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.