Fundus Photo

Basic Information

• Brand Name: Fundus Photo
• Primary DI: 00860010658109
• Version / Model: CFD-440
• Catalog Number: CFD-440
• Company Name: Fundus Photo
• Labeler DUNS: 803778687
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-31
• Public Version: 1
• Public Version Date: 2025-04-08
• Public Version Status: New
• Public Device Record Key: 45cc080e-016c-4277-9663-f8b912d879fd

Device Description

Fundus Photo Digital Imaging System including hardware and/or software

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

GMDN Terms

Code	Name	Definition	Implantable	Status
58861	Multi-purpose digital medical camera lens, intraocular, visible/infrared light	A non-sterile optical device intended for attachment to a multi-purpose digital medical camera to provide high-resolution focusing of digital imaging data from the fundus of the eye. It is typically intended for visualization of the optic disc, macula, and retinal vasculature with a wide field of view and facilitates documentation and screening for retinal lesions and disease using white light or infrared. This is a reusable device.	No	Active
65168	Ophthalmic image analysis software	An application software program intended to be used by: 1) a healthcare professional (e.g., optician, optometrist, ophthalmologist) to analyse, manage, and create reports relating to images of the eye, captured by either a professional ophthalmic device (e.g., slit lamp) or off-the-shelf camera (e.g., smartphone camera); and 2) a patient to upload self-taken images of the eye into their patient record and to receive professional reports. The software is intended to assist professional diagnosis and is not intended for patient self-assessment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860010658109	GS1

Premarket Submissions

Submission Number	Supplement Number
K093071	000