510(k) Report

FDA applicant

Life Imaging Systems, Inc.

Indian Hills, CO2 decisions1996–19990 recalls

FDA records 2 decisions for Life Imaging Systems, Inc. (Indian Hills, CO) from 1996 to 1999: 2 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and LLZ (System, Image Processing, Radiological). Its devices cite 1 predicate, 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 Life Imaging Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Life Imaging Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Life Imaging Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Life Imaging Systems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision
  • LLZSystem, Image Processing, Radiological1decision

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.

  • K961403Life Imaging Systems Lis 6000 aLife Imaging Systems, Inc. · 19963cite it

What has FDA decided for it lately?

  • K990560Life Imaging Systems, Model L3DILife Imaging Systems, Inc. · 1999
  • K961403Life Imaging Systems Lis 6000 aLife Imaging Systems, Inc. · 1996

All 2 as Life Imaging Systems, Inc. →