510(k) Report

FDA applicant

Direx Systems Corp.

Canton, MA22 decisions2003–20120 recalls

FDA records 22 decisions for Direx Systems Corp. (Canton, MA) from 2003 to 2012: 22 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and LNS (Lithotriptor, Extracorporeal Shock-Wave…). Its devices cite 50 predicates, 23 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 Direx Systems Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2007: 22010: 12012: 1
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Direx Systems Corp.’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?

  • IYEAccelerator, Linear, Medical9decisions
  • LNSLithotriptor, Extracorporeal Shock-Wave, Urological7decisions
  • MUJSystem, Planning, Radiation Therapy Treatment3decisions
  • OXOImage-Intensified Fluoroscopic X-Ray System, Mobile2decisions
  • IXIBlock, Beam-Shaping, Radiation Therapy1decision

Whose devices does it build on?

Its devices cite 50 predicates; 23 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 25 times; 23 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.

  • K053640IntegraDirex Systems Corp. · 20064cite it
  • K041582Modification to Tripter X-1 Compact DuetDirex Systems Corp. · 20044cite it
  • K023535Tripter X-1 Compact DuetDirex Systems Corp. · 20034cite it
  • K040553Modification to AcculeafDirex Systems Corp. · 20043cite it
  • K0412133DSCOPEDirex Systems Corp. · 20042cite it
  • K062147Integra SLDirex Systems Corp. · 20061cites it

What has FDA decided for it lately?

  • K111947Duet MagnaDirex Systems Corp. · 2012
  • K102765PronexDirex Systems Corp. · 2010
  • K072529TrackportDirex Systems Corp. · 2007
  • K071701Trackleaf-10Direx Systems Corp. · 2007
  • K063482Crossplan / Accusoft-XL V.4.04Direx Systems Corp. · 2006
  • K062147Integra SLDirex Systems Corp. · 2006
  • K062032Accusoft, Accusoft XLDirex Systems Corp. · 2006
  • K061873VERT-XDirex Systems Corp. · 2006

All 22 as Direx Systems Corp. →