LONGPORT EPISCAN, MODEL-I-200— 510(k) K062571

Substantially Equivalent

Longport, Inc.

FDA 510(k) clearance K062571 for LONGPORT EPISCAN, MODEL-I-200, Substantially Equivalent on 2006-11-21. Applicant: Longport, Inc..

Clearance details

Applicant: Longport, Inc.
Product code: Code IYO
Advisory panel: Radiology
Date received: 2006-08-31
Decision date: 2006-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, VA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.