510(k) Report

FDA applicant

Nines, Inc.

Palo Alto, CA2 decisions2020–20210 recalls

FDA records 2 decisions for Nines, Inc. (Palo Alto, CA) from 2020 to 2021: 2 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and QAS (Radiological Computer-Assisted Triage And…). Its devices cite 2 predicates, 0 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 Nines, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2020: 12021: 1
2020high 1 (2020) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Nines, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological1decision
  • QASRadiological Computer-Assisted Triage And Notification Software1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K202990NinesMeasureNines, Inc. · 20211cites it
  • K193351NinesAINines, Inc. · 20201cites it

What has FDA decided for it lately?

  • K202990NinesMeasureNines, Inc. · 2021
  • K193351NinesAINines, Inc. · 2020

All 2 as Nines, Inc. →