ADDITIONAL FEATURES ESI-3000 ULTRASOUND UNIT— 510(k) K925627

Substantially Equivalent

Elscint, Inc.

FDA 510(k) clearance K925627 for ADDITIONAL FEATURES ESI-3000 ULTRASOUND UNIT, Substantially Equivalent on 1993-10-08. Applicant: Elscint, Inc..

Clearance details

Applicant: Elscint, Inc.
Product code: Code IYO
Advisory panel: Radiology
Date received: 1992-11-06
Decision date: 1993-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hackensack, NJ, 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.