Multi Modality Viewer— 510(k) K161419

Name: FDA 510(k) clearance K161419
Creator: U.S. Food and Drug Administration
Published: 2016-07-13

Substantially Equivalent

Vital Images, Inc.

FDA 510(k) clearance K161419 for Multi Modality Viewer, Substantially Equivalent on 2016-07-13. Applicant: Vital Images, Inc.. Device class: 2.

Clearance details

Applicant: Vital Images, Inc.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2016-05-23
Decision date: 2016-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

view all

More clearances from Vital Images, Inc.

view all

K181247 — Vitrea CT Brain Perfusion2018-11-20
K182230 — Multi Modality Viewer2018-09-07
K172855 — Vitrea Advanced Visualization, Version 7.62017-10-05
K163232 — Vitrea View2017-07-21
K163574 — Multi Modality Viewer2017-01-26

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.