510(k) Report

FDA applicant

Vidar Systems Corp.

Herndon, VA13 decisions1993–20130 recalls

FDA records 13 decisions for Vidar Systems Corp. (Herndon, VA) from 1993 to 2013: 13 510(k) clearances. Most are in product codes LMA (Digitizer, Image, Radiological) and MQB (Solid State X-Ray Imager (Flat Panel/Digital…). Its devices cite 12 predicates, 8 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 Vidar Systems Corp.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2013

2007: 22010: 22013: 2
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • LMADigitizer, Image, Radiological10decisions
  • MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)2decisions
  • JAKSystem, X-Ray, Tomography, Computed1decision

Whose devices does it build on?

Its devices cite 12 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 times; 8 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.

  • K993597PLLL, Teleradpro, Model 12714/12715, VXR-12 Plus, Model 8619/9617Vidar Systems Corp. · 19993cite it
  • K933632Medscan 12Vidar Systems Corp. · 19933cite it
  • K071193Vidar Vision 3000 and 4000 X-Ray SystemsVidar Systems Corp. · 20072cite it
  • K974315Vidar VXR LS Laser Film DigitizerVidar Systems Corp. · 19982cite it
  • K070563Vidar Vision 2000Vidar Systems Corp. · 20071cites it
  • K011049ExpresssuiteVidar Systems Corp. · 20011cites it

What has FDA decided for it lately?

  • K130636Teleradpro Edge; Teleradpro Edge HD-CCDVidar Systems Corp. · 2013
  • K130406Diagnosticpro EdgeVidar Systems Corp. · 2013
  • K102476TeleradproVidar Systems Corp. · 2010
  • K093809Vidar Dental Film DigitizerVidar Systems Corp. · 2010
  • K071193Vidar Vision 3000 and 4000 X-Ray SystemsVidar Systems Corp. · 2007
  • K070563Vidar Vision 2000Vidar Systems Corp. · 2007
  • K024171Vidar Bone Track System SoftwareVidar Systems Corp. · 2003
  • K011049ExpresssuiteVidar Systems Corp. · 2001

All 13 as Vidar Systems Corp. →