VITREAADVANCED— 510(k) K121213

Name: FDA 510(k) clearance K121213
Creator: U.S. Food and Drug Administration
Published: 2012-11-02

Substantially Equivalent

Vital Images, Inc.

FDA 510(k) clearance K121213 for VITREAADVANCED, Substantially Equivalent on 2012-11-02. 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: 2012-04-20
Decision date: 2012-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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More clearances from Vital Images, Inc.

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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 →

Recalls naming K121213

K-number listed on FDA's recall record

Z-1181-2013 — Vitrea¿ CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite. Noninvasive post-processing application designed to evaluate areas of brain perfusion.Class II·Terminated·Vital Images, Inc.·20130315

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121213.

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