M2424A SONOS 5500/4500 DIAGNOSTIC ULTRASOUND SYSTEM, VERSION B.2. 21330A TRANSDUCER— 510(k) K002470

Substantially Equivalent

Agilent Technologies, Inc.

FDA 510(k) clearance K002470 for M2424A SONOS 5500/4500 DIAGNOSTIC ULTRASOUND SYSTEM, VERSION B.2. 21330A TRANSDUCER, Substantially Equivalent on 2000-09-08. Applicant: Agilent Technologies, Inc..

Clearance details

Applicant: Agilent Technologies, Inc.
Product code: Code IYN
Advisory panel: Radiology
Date received: 2000-08-11
Decision date: 2000-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

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.