Duns Number:545824560
Device Description: This equipment adopts advanced opto-mechanical and electrical integration technology, and 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
Catalog Number
-
Brand Name
Fundus Camera
Version/Model Number
SK-680A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PJZ
Product Code Name
Camera, Ophthalmic, General-Use
Public Device Record Key
22d2ec12-ce5f-4e93-81a3-e916a08f549c
Public Version Date
June 16, 2022
Public Version Number
1
DI Record Publish Date
June 08, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |