AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION— 510(k) K110834

Name: FDA 510(k) clearance K110834
Creator: U.S. Food and Drug Administration
Published: 2011-04-26

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K110834 for AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION, Substantially Equivalent on 2011-04-26. Applicant: GE Healthcare. Device class: 2.

Clearance details

Applicant: GE Healthcare
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2011-03-25
Decision date: 2011-04-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Waukesha, WI, US

Download summary PDF View on FDA.gov ↗

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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 K110834

K-number listed on FDA's recall record

Z-0270-2014 — AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION), AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis for diagnosis, except in the case of mammography images. K110834: AW VolumeShare 5 is a review workstation, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis of diagnosis, except in the case of mammography images. K081985: AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications.Class II·Terminated·GE Healthcare, LLC·20130919

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110834.

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