510(k) Report

FDA applicant

Dicomit Imaging Systems Corp.

Richmond Hill, Ontario, CA2 decisions1995–19990 recalls

FDA records 2 decisions for Dicomit Imaging Systems Corp. (Richmond Hill, Ontario, CA) from 1995 to 1999: 2 510(k) clearances. All are in product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 3 predicates, 1 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 Dicomit Imaging Systems Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dicomit Imaging Systems Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Dicomit Imaging Systems Corp. 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?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K951925DicomitDicomit Imaging Systems Corp. · 19952cite it
  • K990248Dicom Image Manager, Model 3-D Visualization OptionDicomit Imaging Systems Corp. · 19991cites it

What has FDA decided for it lately?

  • K990248Dicom Image Manager, Model 3-D Visualization OptionDicomit Imaging Systems Corp. · 1999
  • K951925DicomitDicomit Imaging Systems Corp. · 1995

All 2 as Dicomit Imaging Systems Corp. →