DEVICE: Fundus Photo (00860010658109)
Device Identifier (DI) Information
Fundus Photo
CFD-440
In Commercial Distribution
CFD-440
Fundus Photo
CFD-440
In Commercial Distribution
CFD-440
Fundus Photo
Fundus Photo Digital Imaging System including hardware and/or software
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
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.
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Active | false |
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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HKI | Camera, Ophthalmic, Ac-Powered |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K093071 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
45cc080e-016c-4277-9663-f8b912d879fd
April 08, 2025
1
March 31, 2025
April 08, 2025
1
March 31, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined