Arcus Head Fixation Frame— 510(k) K191701

Substantially Equivalent

Mri Interventions, Inc.

FDA 510(k) clearance K191701 for Arcus Head Fixation Frame, Substantially Equivalent on 2019-11-15. Applicant: Mri Interventions, Inc..

Clearance details

Applicant: Mri Interventions, Inc.
Product code: Code HBL
Advisory panel: Neurology
Date received: 2019-06-25
Decision date: 2019-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HBL

product code HBL

Death: 3
Injury: 753
Malfunction: 1,421
Total: 2,177

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.