FDAFDA · Alimentos y medicamentos·N.º oficial Z-0024-2013
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.
Publicado el 31 de octubre de 2012 · Inicio del retiro: 7 de septiembre de 2012
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Devices labeled for an intended use not included in the existing 510(k) or PMA. Specifically, "The Retina" poster provided with the systems, and the book "RETINAL OCT Analysis and Interpretation Method" by Bruno Lumbroso and Marco Rispoli which are not labeled within 51O(k) cleared product description.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Optovue Inc.
- Distribuidor
- Worldwide Distribution -- USA (nationwide) and Internationally.
- Lote
- All units of these models.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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