Fundus Camera

Primary DI
06973211070008
Brand
Fundus Camera
Company
CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
Model
SK-680A
Device description
This equipment adopts advanced opto-mechanical and electrical integration technology, and integrates fundus digital image acquisition and image processing system. It can display color fundus images continuously, real-time and high-quality.The fundus digital image acquisition and image processing system processes the static images of the fundus color images with full digital processing, completes real-time recording and storage, and can be used for image processing, inspection reports, graphic editing, and data retrieval management for medical record generation at any time. The size of the lesion can be measured and calculated, the image can be scaled, moved, and pasted, and the color of the image can be adjusted. The image data of the case can be exported to the U disk and attached to the patient's case, which can assist scientific research and teaching
Published
2022-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PJZCamera, Ophthalmic, General-Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PJZCamera, Ophthalmic, General-UseOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973211070008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973211070008069732110700086973211070008

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic fundus cameraAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
545824560
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973211070619Fundus Camera SK-650B2025-08-18
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06973211070947Ophthalmic Slit Lamp MicroscopeLS-7C2025-08-18
06973211070954Ophthalmic Slit Lamp MicroscopeLS-7CS2025-08-18
06973211070961Ophthalmic Slit Lamp MicroscopeLS-7CE2025-08-18
06973211070978Ophthalmic Slit Lamp MicroscopeLS-8A2025-08-18
06973211070985Ophthalmic Slit Lamp MicroscopeLS-9CS2025-08-18
06973211071500Fundus CameraSK-680B2025-08-18
06973211071517Fundus CameraSK-680C2025-08-18
06973211071623Corneal Topographer SK-7000A2025-08-18
06973211071630Corneal Topographer SK-7000B2025-08-18
06973211071869Kerato refractometerSK-6800A2025-08-18
06973211071876Kerato refractometerSK-6800B2025-08-18
06973211070633Ophthalmic Ultrasound Examination InstrumentSK-3000A2023-01-17
06973211070640Ophthalmic Ultrasound Examination InstrumentSK-2000AP2023-01-17
06973211070701Ophthalmic Ultrasound Examination InstrumentSK-3000B2023-01-17
06973211070718Ophthalmic Ultrasound Examination InstrumentSK-3000C2023-01-17
06973211070749Ophthalmic Ultrasound Examination InstrumentSK-2000A2023-01-17
06973211070756Ophthalmic Ultrasound Examination InstrumentSK-2000P2023-01-17
06973211070916Sunkingdom RetinometerSK-6500A2023-01-17

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