510(k) K113451 ยท HKI Camera, Ophthalmic, Ac-Powered
NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX
| Applicant | Nidek Technologies Srl, Albignasego (Padova), IT |
| Decision | Substantially Equivalent, May 8, 2012 |
| Received | Nov 21, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113451
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2014 | Nidek Inc Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and anterior segment of the eye.
Distributed by Nidek, Inc, and Marco Opthalmic Inc. Terminated |
HKI | None listed |
| Aug 23, 2013 | Nidek Inc NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images. Terminated |
HKI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.