NA - This system adopts the most advanced - Chongqing Kanghuaruiming S&T Co., Ltd..

Duns Number:543066376

Device Description: This system adopts the most advanced Optical-electro-mechanical Integration technology. It 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.

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

APS-CER

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

HKI

Product Code Name

Camera, Ophthalmic, Ac-Powered

Device Record Status

Public Device Record Key

a256a41a-298f-4317-8363-762bd2dc59f5

Public Version Date

April 23, 2018

Public Version Number

1

DI Record Publish Date

March 22, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CHONGQING KANGHUARUIMING S&T CO., LTD.." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 7