U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Tomography optical coherence - Product Code OBO
원인
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.
조치
Optovue Inc., sent a Voluntary Field Correction and Removal letter dated September 6, 2012, to all affected customers. The letter identified the product the problem and the action to be taken by the customer .
Please sign and return the attached form indicating your acknowledgement that that the Affected Materials have been returned or destroyed.
If you have any further questions please contact Optovue, at 1-866-344-8948.
Worldwide Distribution -- USA (nationwide) and Internationally.
제품 설명
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.