NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARE— 510(k) K140828

Substantially Equivalent

Brainreader Aps

FDA 510(k) clearance K140828 for NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARE, Substantially Equivalent on 2015-02-04. Applicant: Brainreader Aps.

Clearance details

Applicant: Brainreader Aps
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2014-04-01
Decision date: 2015-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Egaa, DK

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.