510(k) Report

FDA applicant

Candelis, Inc.

Denton, TX4 decisions2008–20260 recalls

FDA records 4 decisions for Candelis, Inc. (Denton, TX) from 2008 to 2026: 4 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 3 predicates, 2 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 Candelis, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2008: 12009: 12011: 12026 (partial year): 1
2008high 1 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Candelis, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological4decisions

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 2 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.

  • K092949Imagegrid Radiology Viewer SystemCandelis, Inc. · 20093cite it
  • K111694ASTRACandelis, Inc. · 20112cite it
  • K080333ImagegridCandelis, Inc. · 20081cites it

What has FDA decided for it lately?

  • K262143ImageGrid StreamVueCandelis, Inc. · 2026
  • K111694ASTRACandelis, Inc. · 2011
  • K092949Imagegrid Radiology Viewer SystemCandelis, Inc. · 2009
  • K080333ImagegridCandelis, Inc. · 2008

All 4 as Candelis, Inc. →