NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARE— 510(k) K140828

Name: FDA 510(k) clearance K140828
Creator: U.S. Food and Drug Administration
Published: 2015-02-04

Substantially Equivalent

Brainreader Aps

FDA 510(k) clearance K140828 for NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARE, Substantially Equivalent on 2015-02-04. Applicant: Brainreader Aps. Device class: 2.

Clearance details

Applicant: Brainreader Aps
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
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 ↗

Recent devices under product code LLZ

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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 →

Recalls naming K140828

K-number listed on FDA's recall record

Z-0934-2021 — Neuroreader Medical Image Processing Software - Product Usage: intended to automate the current manual process of identifying, labeling, and quantifying the volume of segmentable brain structures identified on MR images.Class II·Terminated·Brainreader ApS·20201214

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140828.

Data sourced from openFDA. This site is unofficial and independent of the FDA.