510(k) Report

FDA applicant

Ceevra, Inc.

San Francisco, CA6 decisions2017–20260 recalls

FDA records 6 decisions for Ceevra, Inc. (San Francisco, CA) from 2017 to 2026: 6 510(k) clearances. Most are in product codes QIH (Automated Radiological Image Processing Software) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 95 days from receipt to decision, against 140 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 5 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 Ceevra, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2017: 12018: 12023: 22025: 12026 (partial year): 1
2017high 2 (2023) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Ceevra, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ceevra, 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?

  • QIHAutomated Radiological Image Processing Software4decisions
  • LLZSystem, Image Processing, Radiological2decisions

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 95 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 140 days; 4 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 5 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.

  • K173274Ceevra Reveal 2.0Ceevra, Inc. · 20186cite it
  • K222676Ceevra Reveal 3Ceevra, Inc. · 20233cite it
  • K171356Clarity RevealCeevra, Inc. · 20171cites it
  • K233568Ceevra Reveal 3+Ceevra, Inc. · 20231cites it
  • K243933Ceevra Reveal 3+Ceevra, Inc. · 20251cites it

What has FDA decided for it lately?

  • K261595Ceevra Reveal 4Ceevra, Inc. · 2026
  • K243933Ceevra Reveal 3+Ceevra, Inc. · 2025
  • K233568Ceevra Reveal 3+Ceevra, Inc. · 2023
  • K222676Ceevra Reveal 3Ceevra, Inc. · 2023
  • K173274Ceevra Reveal 2.0Ceevra, Inc. · 2018
  • K171356Clarity RevealCeevra, Inc. · 2017

All 6 as Ceevra, Inc. →