510(k) Report

FDA applicant

Xitec, Inc.

North Attleboro, MA2 decisions1999–20000 recalls

FDA records 2 decisions for Xitec, Inc. (North Attleboro, MA) from 1999 to 2000: 2 510(k) clearances. All are in product code OXO (Image-Intensified Fluoroscopic X-Ray System…). 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 Xitec, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Xitec, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Xitec, Inc. 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?

  • OXOImage-Intensified Fluoroscopic X-Ray System, Mobile2decisions

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K003568Xiscan 6000 Imaging SystemXitec, Inc. · 20001cites it

What has FDA decided for it lately?

  • K003568Xiscan 6000 Imaging SystemXitec, Inc. · 2000
  • K984406Xiscan Office Expert Imaging System, Xiscan Surgical Expert Imaging SystemXitec, Inc. · 1999

All 2 as Xitec, Inc. →

Other applicant names beginning “Xitec”

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

Xitec Holdings, LLC 1