M2430 DIAGNOSTIC ULTRASOUND SYSTEM WITH THE 21420 TRANSDUCER— 510(k) K002397

Substantially Equivalent

Agilent Technologies, Inc.

FDA 510(k) clearance K002397 for M2430 DIAGNOSTIC ULTRASOUND SYSTEM WITH THE 21420 TRANSDUCER, Substantially Equivalent on 2000-08-17. Applicant: Agilent Technologies, Inc..

Clearance details

Applicant: Agilent Technologies, Inc.
Product code: Code IYN
Advisory panel: Radiology
Date received: 2000-08-07
Decision date: 2000-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

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Adverse events under product code IYN

product code IYN

Death: 25
Injury: 163
Malfunction: 1,538
Other: 4
Total: 1,730

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.