Volpara Imaging Software— 510(k) K153427

Name: FDA 510(k) clearance K153427
Creator: U.S. Food and Drug Administration
Published: 2016-01-07

Substantially Equivalent

Matakina Technology, Ltd.

FDA 510(k) clearance K153427 for Volpara Imaging Software, Substantially Equivalent on 2016-01-07. Applicant: Matakina Technology, Ltd.. Device class: 2.

Clearance details

Applicant: Matakina Technology, Ltd.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2015-11-25
Decision date: 2016-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wellington, NZ

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

view all

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.