NON-MYDRIATIC AUTO FUNDUS CAMERA

Basic Information

• Brand Name: NON-MYDRIATIC AUTO FUNDUS CAMERA
• Primary DI: 04987669100554
• Version / Model: AFC-330
• Company Name: NIDEK CO.,LTD.
• Labeler DUNS: 690635461
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-24
• Public Version: 4
• Public Version Date: 2018-09-24
• Public Version Status: Update
• Public Device Record Key: 91d055db-a309-4e61-8b4a-ece710b144fd

Device Description

The NIDEK NON-MYDRIATIC AUTO FUNDUS CAMERA, AFC-330 captures fundus images using a built-in color CCD camera without the use of mydriatic agents. The AFC-330 is useful not only for ophthalmology but also for fundus photography in medical examinations such as for diabetes. With this single device, registration of patient information, image capture, and viewing of captured images are possible. In addition, captured images can be output to a USB flash drive, and printed using a printer. By connecting a personal computer (PC) to the device via a LAN and installing the optional image filing system software, images captured by this device can be transferred to the PC at high speed, and viewed and managed on the PC.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HKI	Camera, Ophthalmic, Ac-Powered	Ophthalmic	886.1120	2
NFF	Device, Storage, Images, Ophthalmic	Radiology	892.2010	1
NFG	Device, Communications, Images, Ophthalmic	Radiology	892.2020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
10551	Ophthalmic fundus camera	An electrically-powered optical device intended to be used to create digital colour photographic images/video of the ocular fundus (interior eye surface opposite the lens) through the pupil, to aid in diagnosing and monitoring retinal pathology; it may also be used for images/video of the anterior chamber. The image/video is typically transferred to a computer for display on its screen and/or for storage in a database. This device is also known as a retinal camera.	No	Active
45724	Eye anterior segment analyser software	An application software program designed for the collection, processing, and display of data resulting from the measurement/evaluation of various properties of the anterior segment of the eye (i.e., cornea, iris, pupil, anterior chamber and lens) performed with an eye anterior segment analyser. It may be installed in the integrated analyser computer and/or an off-the-shelf computer (e.g., desktop, laptop).	No	Active
52748	Posterior eye segment analyser software	An application software program designed for the collection, processing, and display of data resulting from the measurement/evaluation of various properties of the posterior eye segment performed with an anterior eye segment analyser. It may be installed in the integrated analyser computer and/or an off-the-shelf computer (e.g., desktop, laptop).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04987669100554	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]