510(k) Report

FDA applicant

Echotech 3D Imaging Systems, Inc.

Indian Hills, CO2 decisions1998–20020 recalls

FDA records 2 decisions for Echotech 3D Imaging Systems, Inc. (Indian Hills, CO) from 1998 to 2002: 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.

FDA’s records also spell it “Echotech 3D Imaging Systems GmbH”.

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 Echotech 3D Imaging Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Echotech 3D Imaging Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Echotech 3D Imaging Systems, 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?

  • 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 7 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.

  • K980308Echotech 3D FreescanEchotech 3D Imaging Systems GmbH · 19985cite it
  • K013088Echotech Easy 3D Family, Echotech 3D Freescan, Echotech Easyarchive, Echotech Quanticon, Echotech EasystressEchotech 3D Imaging Systems, Inc. · 20022cite it

What has FDA decided for it lately?

  • K013088Echotech Easy 3D Family, Echotech 3D Freescan, Echotech Easyarchive, Echotech Quanticon, Echotech EasystressEchotech 3D Imaging Systems, Inc. · 2002
  • K980308Echotech 3D FreescanEchotech 3D Imaging Systems GmbH · 1998

The one decision as Echotech 3D Imaging Systems, Inc. →The one decision as Echotech 3D Imaging Systems GmbH →