Devices

Device Recall Optovue iVue with Normative Database

Model / Serial
iVue software version 3.0 and 3.1 3.1 is international version, only distributed to Canada but not currently installed in any Canadian facilities.
Product Classification
Ophthalmic Devices
Device Class
2
Implanted device?
No
Distribution
Distributed Nationwide and in Canada.
Product Description
Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. || Intended for in vivo imaging.
Manufacturer
Optovue, Inc.
1 Event
- Recall of Device Recall Optovue iVue with Normative Database

Manufacturer

Optovue, Inc.

Manufacturer Address
Optovue, Inc., 2800 Bayview Dr, Fremont CA 94538-6518
Manufacturer Parent Company (2017)
Optovue Inc.
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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