FDA.report

Fundus Photo

Primary DI
00860010658109
Brand
Fundus Photo
Company
Fundus Photo
Model
CFD-440
Catalog number
CFD-440
Device description
Fundus Photo Digital Imaging System including hardware and/or software
Published
2025-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HKICamera, Ophthalmic, Ac-Powered

Product Code Classifications

CodeDeviceSpecialtyClass
HKICamera, Ophthalmic, Ac-PoweredOphthalmic2

Premarket Submissions

SubmissionSupplement
K093071000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K093071000FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440Fundus Photo, LLC2010-11-17HKI

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00860010658109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010658109008600106581098600106581090860010658109

GMDN Terms

TermDefinition
Ophthalmic image analysis softwareAn 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
803778687
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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