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510(k) Data Aggregation
K Number
K180306Device Name
Nexy
Manufacturer
Next Sight srl
Date Cleared
2018-06-08
(126 days)
Product Code
HKI
Regulation Number
886.1120Why did this record match?
Applicant Name (Manufacturer) :
Next Sight srl
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nexy device is an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent.
Device Description
The Nexy medical device is an automatic eye-fundus camera without the use of a mydriatic agent, designed to take color photos of the retinal fundus with a 45° field.
The device consists of two fundamental components: the eye-fundus camera and the tablet which represents the user interface where running a dedicated software application.
The instrument body includes: optical head, forehead and cheekbones rests and a base. The device is provided also with a front lens cap, a power cord and AC/DC adaptor.
Through the tablet, the user starts the automatic examination that provides as output the photo of the patient's retina saved in the internal database of the device in JPEG format.
The device can be used in a hospital environment, public and private health clinics and in public and private environments where eye or systemic diseases are screened.
The device must be used by medical personnel in some cases assisted by health professionals and/or optometry professionals. Users must be adequately trained in the use of the device and informed about the risks and side effects as well as being in possession of the qualifications required by law.
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