GE B510 TRANSDUCER— 510(k) K951723

Substantially Equivalent

GE Medical Systems

FDA 510(k) clearance K951723 for GE B510 TRANSDUCER, Substantially Equivalent on 1995-11-14. Applicant: GE Medical Systems.

Clearance details

Applicant: GE Medical Systems
Product code: Code ITX
Advisory panel: Radiology
Date received: 1995-04-14
Decision date: 1995-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.