CLEARMRI HELIOS-RG8 COIL ACCESSORY KIT— 510(k) K132381

Substantially Equivalent

Clearmri Solutions, Inc.

FDA 510(k) clearance K132381 for CLEARMRI HELIOS-RG8 COIL ACCESSORY KIT, Substantially Equivalent on 2014-04-04. Applicant: Clearmri Solutions, Inc..

Clearance details

Applicant: Clearmri Solutions, Inc.
Product code: Code LNH
Advisory panel: Radiology
Date received: 2013-07-31
Decision date: 2014-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

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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.