510(k) Report

FDA applicant

Instrumentarium Corp. Imaging Division

Milwaukee, WI3 decisions2002–20050 recalls

FDA records 3 decisions for Instrumentarium Corp. Imaging Division (Milwaukee, WI) from 2002 to 2005: 3 510(k) clearances. Most are in product codes IZH (System, X-Ray, Mammographic) and EHD (Unit, X-Ray, Extraoral With Timer). Its devices cite 8 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 Instrumentarium Corp. Imaging Division’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Instrumentarium Corp. Imaging Division since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Instrumentarium Corp. Imaging Division 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?

  • IZHSystem, X-Ray, Mammographic2decisions
  • EHDUnit, X-Ray, Extraoral With Timer1decision

Whose devices does it build on?

Its devices cite 8 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K043612Orthopantomograph OP200, OP200D, and Orthoceph OC200, OC200DInstrumentarium Corp. Imaging Division · 20053cite it

What has FDA decided for it lately?

  • K043612Orthopantomograph OP200, OP200D, and Orthoceph OC200, OC200DInstrumentarium Corp. Imaging Division · 2005
  • K023864Performa StereoInstrumentarium Corp. Imaging Division · 2003
  • K022275Delta 32; Delta 32 TactInstrumentarium Corp. Imaging Division · 2002

All 3 as Instrumentarium Corp. Imaging Division →

Other applicant names beginning “Instrumentarium”

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

Instrumentarium Imaging, Inc. 24Instrumentarium Corp. 20Instrumentarium Dental, Palodex Group OY 5Instrumentarium-Datex 2Instrumentarium Dental, Inc. 1