NA

Primary DI
06951214400084
Brand
NA
Company
Chongqing Kanghuaruiming S&T Co., Ltd..
Model
APS-BER
Device description
This system adopts the most advanced Optical-electro-mechanical Integration technology. It integrates digital Fundus-Fluorescein-Angiography camera and digital-fundus-images acquisition and processing system, which can continuously display real-time, high quality color fundus images as well as black-white Fundus-Fluorescein-Angiography video images. The fundus images acquisition and processing system can process (full digital), record (real-time and completely) and save the color fundus images as well as retinal-fluorescein-angiography dynamic & static images into the computer. You can modify pictures, check reports, edit Graph-texts and manage all the dates at any time you want; you can measure and calculate the size of the case focus; you can zoom, move, stick, and put together the pictures; you can adjust the color on the picture, you can also record all the data on the CD, which can assistant scientific research and teaching. This system has combine function of many fundus image acquisition instruments, which can support medical treatments.
Published
2018-03-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HKICamera, Ophthalmic, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKICamera, Ophthalmic, Ac-PoweredOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06951214400084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06951214400084069512144000846951214400084

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
543066376
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06951214400015NASLM-1ER2018-03-21
06951214400022NASLM-2ER2018-03-21
06951214400039NASLM-3ER2018-03-22
06951214400077NAAPS-AER2018-03-22
06951214400091NAAPS-6000BER2018-03-22
06951214400107NAAPS-6000CER2018-03-22
06951214400213NAAPS-CER2018-03-22
06951214400220NAAPS-DER2018-03-22
06951214400237NAAPS-6000AER2018-03-22
06951214400244NAAPS-T302018-03-22
06951214400251NAAPS-T602018-03-22
06951214400268NAAPS-T902018-03-22
06951214400275NAAPS-T002018-03-22

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