510(k) Report

FDA applicant

Innovative Imaging, Inc.

Sacramento, CA2 decisions1990–20041 recall

FDA records 2 decisions for Innovative Imaging, Inc. (Sacramento, CA) from 1990 to 2004: 2 510(k) clearances. All are in product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 1 predicate, 1 of them its own earlier devices. 1 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 Innovative Imaging, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Innovative Imaging, Inc. since 2007.

Recalls per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Innovative Imaging, 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

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K902007I3SYSTEM-AbdInnovative Imaging, Inc. · 19901cites it

What has FDA decided for it lately?

  • K041947I3 System-Abd Diagnostic UltrasoundInnovative Imaging, Inc. · 20041 recall
  • K902007I3SYSTEM-AbdInnovative Imaging, Inc. · 1990

All 2 as Innovative Imaging, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K041947Ellex, Eye Cubed, I 3 System-ABD Ultrasound Version 3.0 with Software Version 3.0 and…Sep 25, 2007