AI5200 DIAG ULTRA SOUND SYST INCLUD 7.5 & 10.0 MHZ— 510(k) K924458

Substantially Equivalent

Acoustic Imaging Technologies Corp.

FDA 510(k) clearance K924458 for AI5200 DIAG ULTRA SOUND SYST INCLUD 7.5 & 10.0 MHZ, Substantially Equivalent on 1993-01-21. Applicant: Acoustic Imaging Technologies Corp..

Clearance details

Applicant: Acoustic Imaging Technologies Corp.
Product code: Code IYO
Advisory panel: Radiology
Date received: 1992-09-02
Decision date: 1993-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Phoenix, AZ, US

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Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.