FDA applicant

Acoustic Medsystems, Inc.

Savoy, IL2 decisions2013–20160 recalls

FDA records 2 decisions for Acoustic Medsystems, Inc. (Savoy, IL) from 2013 to 2016: 2 510(k) clearances. Most are in product codes MUJ (System, Planning, Radiation Therapy Treatment) and NTB (System, Ablation, Ultrasound And Accessories). Its devices cite 8 predicates, 0 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 Acoustic Medsystems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Acoustic Medsystems, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Other applicant names beginning “Acoustic”

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

Acoustic Imaging Technologies Corp. 3 Acoustic Imaging 2

Acoustic Medsystems, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Acoustic”