510(k) Report

FDA applicant

Arterys, Inc.

San Francisco, CA8 decisions2016–20250 recalls

FDA records 8 decisions for Arterys, Inc. (San Francisco, CA) from 2016 to 2025: 8 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and QIH (Automated Radiological Image Processing Software). Since 2016 its 510(k)s took a median of 62 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 7 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Arterys, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2016: 12017: 22018: 22020: 12022: 12025: 1
2016high 2 (2017) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Arterys, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Arterys, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological5decisions
  • QIHAutomated Radiological Image Processing Software3decisions

How long do its 510(k) reviews take?

Since 2016, its 8 510(k)s took a median of 62 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 107 days; 6 of its 8 were faster than that.

Whose devices does it build on?

Its devices cite 12 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 7 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K171544Arterys ViewerArterys, Inc. · 20172cite it
  • K173542Arterys Oncology DLArterys, Inc. · 20182cite it
  • K162513Arterys Software v2.0Arterys, Inc. · 20161cites it
  • K203744Arterys MICAArterys, Inc. · 20221cites it
  • K182034Arterys MICAArterys, Inc. · 20181cites it
  • K163253Arterys Cardio DLArterys, Inc. · 20171cites it

What has FDA decided for it lately?

  • K252539Tempus PixelArterys, Inc. · 2025
  • K203744Arterys MICAArterys, Inc. · 2022
  • K192437Arterys MICAArterys, Inc. · 2020
  • K182034Arterys MICAArterys, Inc. · 2018
  • K173542Arterys Oncology DLArterys, Inc. · 2018
  • K171544Arterys ViewerArterys, Inc. · 2017
  • K163253Arterys Cardio DLArterys, Inc. · 2017
  • K162513Arterys Software v2.0Arterys, Inc. · 2016

All 8 as Arterys, Inc. →