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Image filing software NAVIS-EX

NIDEK CO.,LTD. · Model 1.12 · UDI-DI 04987669200636

NFG NFF MYC HKI HPT OBO HJO NFJ Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The NAVIS-EX image filing software is software that acquires data from the following NIDEK fundus photography devices and files it for easy transfer to external systems. NAVIS-EX is equipped with functions for image acquiring, image display, image drawing, image processing, image measurement, panorama image creation, stereo image observation, composite image creation, and Follow-Up. (According to the image, available functions are limited.) Image data can be transferred by network or e-mail. NAVIS-EX can construct a network among multiple terminals and refers to and edits data from the client PC.

Recalls

Date	Firm	Reason
2016-03-01	Alcon Research, Ltd.	Alcon is conducting a voluntary medical device correction of all VERION Reference Units (Vision Planner) that are shared with the Alcon LenSx Laser System after receiving reports c

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.