510(k) Report

FDA applicant

Virtual Radiologic Corporation

Eden Prairie, MN3 decisions2009–20241 recall

FDA records 3 decisions for Virtual Radiologic Corporation (Eden Prairie, MN) from 2009 to 2024: 3 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 4 predicates, 1 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 Virtual Radiologic Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2009: 12016: 12024: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2023

2023: 1
2009high 1 (2023) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Virtual Radiologic Corporation by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Virtual Radiologic Corporation’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, Radiological3decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K090649Vrad Picture Archiving and Communications System SoftwareVirtual Radiologic Corporation · 20091cites it
  • K162145vRad PACS with MammographyVirtual Radiologic Corporation · 20161cites it

What has FDA decided for it lately?

  • K241879vRad ViewerVirtual Radiologic Corporation · 2024
  • K162145vRad PACS with MammographyVirtual Radiologic Corporation · 20161 recall
  • K090649Vrad Picture Archiving and Communications System SoftwareVirtual Radiologic Corporation · 2009

All 3 as Virtual Radiologic Corporation →

What has been recalled?

1 recall linked to its devices; the latest:

  • K162145vRad PACS with MammographyMay 9, 2023Class II

Other applicant names beginning “Virtual”

FDA records each applicant name separately; these may or may not be the same firm.

Virtual Imaging, Inc. 9Virtual Corp. 9Virtual Ports, Ltd. 2Virtual Incision 2