IMRI 1.5T AND IMRI 3T S— 510(k) K133692

Substantially Equivalent

Imris, Inc.

FDA 510(k) clearance K133692 for IMRI 1.5T AND IMRI 3T S, Substantially Equivalent on 2014-02-10. Applicant: Imris, Inc..

Clearance details

Applicant: Imris, Inc.
Product code: Code LNH
Advisory panel: Radiology
Date received: 2013-12-02
Decision date: 2014-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, 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.