International Medical Devices Database

Manufacturer Address
Optovue Inc., 2800 Bayview Dr, Fremont CA 94538-6518
Manufacturer Parent Company (2017)
Optovue Inc.
Source
USFDA
1 Event
- Recall of Optovue RTVue, iVue

One device in the database

Optovue RTVue, iVue

Model / Serial
All units of these models.
Product Classification
Ophthalmic Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- USA (nationwide) and Internationally.
Product Description
Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; || The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA || The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

2 manufacturers with a similar name

Learn more about the data here

Optovue Inc.

Manufacturer Address
Optovue Inc., 45531 Northport Loop W, Fremont CA 94538-6417
Manufacturer Parent Company (2017)
Optovue Inc.
Source
USFDA

Optovue Inc.

Manufacturer Address
Optovue Inc., 45331 Northport Loop W, Fremont CA 94538-6417
Manufacturer Parent Company (2017)
Optovue Inc.
Source
USFDA

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Disclaimer

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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The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

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