510(k) Report

FDA applicant

Pie Medical Equipment B.V.

Maastricht, NL8 decisions1990–19980 recalls

FDA records 8 decisions for Pie Medical Equipment B.V. (Maastricht, NL) from 1990 to 1998: 8 510(k) clearances. Most are in product codes ITX (Transducer, Ultrasonic, Diagnostic) and IZI (System, X-Ray, Angiographic). Its devices cite 3 predicates, 0 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 Pie Medical Equipment B.V.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pie Medical Equipment B.V. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pie Medical Equipment B.V. 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?

  • ITXTransducer, Ultrasonic, Diagnostic3decisions
  • IZISystem, X-Ray, Angiographic2decisions
  • HGLTransducer, Ultrasonic, Obstetric1decision
  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic1decision
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K982203Caas II Lva Biplane OptionPie Medical Equipment B.V. · 19982cite it
  • K945540Caas IIPie Medical Equipment B.V. · 19952cite it

What has FDA decided for it lately?

  • K982203Caas II Lva Biplane OptionPie Medical Equipment B.V. · 1998
  • K945540Caas IIPie Medical Equipment B.V. · 1995
  • K915647Diagnostic Ultrasound System Model SC250Pie Medical Equipment B.V. · 1992
  • K912819SC1150 CW/PDPie Medical Equipment B.V. · 1992
  • K911584Diagnostic Ultrasound System Model SC480Pie Medical Equipment B.V. · 1991
  • K911043Hemisphere Multiplane Endorectal ProbePie Medical Equipment B.V. · 1991
  • K9110447.5 MHZ Apas Transducer (Art.Nol: 50.04918.1)Pie Medical Equipment B.V. · 1991
  • K900838Transvaginal Transducer AssemblyPie Medical Equipment B.V. · 1990

All 8 as Pie Medical Equipment B.V. →