510(k) Report

FDA applicant

Avreo, Inc.

N Charleston, SC2 decisions2007–20140 recalls

FDA records 2 decisions for Avreo, Inc. (N Charleston, SC) from 2007 to 2014: 2 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 3 predicates, 1 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 Avreo, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2007: 12014: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Avreo, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Avreo, 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, Radiological2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K070755InterworksAvreo, Inc. · 20071cites it

What has FDA decided for it lately?

  • K141556Avreo Interworks SystemAvreo, Inc. · 2014
  • K070755InterworksAvreo, Inc. · 2007

All 2 as Avreo, Inc. →