510(k) Report

FDA applicant

Medirex, Inc.

Wellesley Hills, MA4 decisions1996–19970 recalls

FDA records 4 decisions for Medirex, Inc. (Wellesley Hills, MA) from 1996 to 1997: 3 510(k) clearances and 1 original PMA approval. Most are in product codes OXO (Image-Intensified Fluoroscopic X-Ray System…) and LLZ (System, Image Processing, Radiological). 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 Medirex, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medirex, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medirex, 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
  • LLZSystem, Image Processing, Radiological1decision
  • LNSLithotriptor, Extracorporeal Shock-Wave, Urological1decision

Who builds on its devices?

Later devices cite its devices 4 times; 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.

  • P920034Tripter-X1 NovaMedirex, Inc. · 19962cite it
  • K965013Digiscope RX-2 (9 Option)Medirex, Inc. · 19971cites it
  • K964327IPU RX-2Medirex, Inc. · 19971cites it

What has FDA decided for it lately?

  • K965013Digiscope RX-2 (9 Option)Medirex, Inc. · 1997
  • K964327IPU RX-2Medirex, Inc. · 1997
  • P920034Tripter-X1 NovaMedirex, Inc. · 1996
  • K960198Digiscope RX-2Medirex, Inc. · 1996

All 4 as Medirex, Inc. →