MODIFICATION TO: AURORA— 510(k) K052698

Substantially Equivalent

Aurora Imaging Technology, Inc.

FDA 510(k) clearance K052698 for MODIFICATION TO: AURORA, Substantially Equivalent on 2005-11-08. Applicant: Aurora Imaging Technology, Inc..

Clearance details

Applicant: Aurora Imaging Technology, Inc.
Product code: Code LNH
Advisory panel: Radiology
Date received: 2005-09-28
Decision date: 2005-11-08
Decision: Substantially Equivalent
Clearance type: Special
Location: North Andover, MA, 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.