LumiCoil Platinum Fiducial Marker— 510(k) K173251

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K173251 for LumiCoil Platinum Fiducial Marker, Substantially Equivalent on 2017-12-19. Applicant: Boston Scientific Corporation.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code IYE
Advisory panel: Radiology
Date received: 2017-10-10
Decision date: 2017-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlboro, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

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.