May

2010

Cl Il Optovue RTVue Optical Coherence Tomography

Company:Optovue Inc.
Date of Enforcement Report 5/12//2010
Class:ll

PRODUCT
Optovue RTVue Optical Coherence Tomography (OCT), Model-RT100 with software versions 3.0.x.x and higher. The RTVue 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. Recall # Z-1131-2010

REASON
Marketed without proper 510(k) — No 510(k) clearance for Optovue RTVue Model-RT100 with Software Versions 3.0.x.x and higher which includes the Normative Database.

RECALLING FIRM/MANUFACTURER
Optovue Inc., Fremont, CA, by letter on January 8, 2010. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
591 devices

DISTRIBUTION
Nationwide and Internationally

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl Il Optovue RTVue Optical Coherence Tomography

Amy Sellers

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