BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0— 510(k) K061255

Substantially Equivalent

Kyron Clinical Imaging, Inc.

FDA 510(k) clearance K061255 for BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0, Substantially Equivalent on 2006-06-13. Applicant: Kyron Clinical Imaging, Inc..

Clearance details

Applicant: Kyron Clinical Imaging, Inc.
Product code: Code LNH
Advisory panel: Radiology
Date received: 2006-05-04
Decision date: 2006-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wauwatosa, 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.