Volpara Imaging Software— 510(k) K211279

Name: FDA 510(k) clearance K211279
Creator: U.S. Food and Drug Administration
Published: 2021-07-27

Substantially Equivalent

Volpara Health Technologies Limited

FDA 510(k) clearance K211279 for Volpara Imaging Software, Substantially Equivalent on 2021-07-27. Applicant: Volpara Health Technologies Limited. Device class: 2.

Clearance details

Applicant: Volpara Health Technologies Limited
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2021-04-27
Decision date: 2021-07-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Wellington, NZ

Download summary PDF View on FDA.gov ↗

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K182310 — Volpara Imaging Software2018-09-21

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.