SIGNA Pioneer— 510(k) K153003

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K153003 for SIGNA Pioneer, Substantially Equivalent on 2015-10-27. Applicant: GE Healthcare.

Clearance details

Applicant: GE Healthcare
Product code: Code LNH
Advisory panel: Radiology
Date received: 2015-10-13
Decision date: 2015-10-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Waukesha, WI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

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.