510(k) Report

FDA applicant

Vidistar, LLC

Greenville, SC2 decisions2009–20151 recall

FDA records 2 decisions for Vidistar, LLC (Greenville, SC) from 2009 to 2015: 2 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 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 Vidistar, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2009: 12015: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2018

2018: 1
2009high 1 (2018) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Vidistar, LLC by year, 2009–2026Sources: 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, Radiological2decisions

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K152822VidiStar HeartViewVidistar, LLC · 2015
  • K083910Vidistar Pacs & Dicom Viewer Software Server Software System, Heart View, Standalone ViewerVidistar, LLC · 20091 recall

All 2 as Vidistar, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K083910VidiStar (TM) PACS & DICOM Viewer Software systemAug 28, 2018Class II