510(k) Report

FDA applicant

Sound Imaging, Inc.

Mchenry, IL1 decision1984–19840 recalls

FDA records 1 decision for Sound Imaging, Inc. (Mchenry, IL) in 1984: 1 510(k) clearance. All are in product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). 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 Sound Imaging, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sound 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, Ultrasonic1decision

What has FDA decided for it lately?

  • K833231Sound Imager ISound Imaging, Inc. · 1984

The one decision as Sound Imaging, Inc. →

Other applicant names beginning “Sound”

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

Sound Surgical Technologies, LLC 6Sound Health Systems, Inc. 2Sound 2000 Medical Systems, Inc. 1Sound Options Tinnitus Treatments, Inc. 1Sound Life Sciences, Inc. 1Sound Land Corp. 1Sound Acoustic Systems, Ltd. 1Sound Crafters Hearing Instruments 1Sound Technique System, LLC 1Sound Hearing Instruments, Inc. 1Sound Linked Data, Inc. 1