Fundus Camera

GUDID 06973211070008

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

CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD

Ophthalmic fundus camera

• Primary Device ID: 06973211070008
• NIH Device Record Key: 22d2ec12-ce5f-4e93-81a3-e916a08f549c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fundus Camera
• Version Model Number: SK-680A
• Company DUNS: 545824560
• Company Name: CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973211070008 [Primary]

FDA Product Code

• PJZ: Camera, Ophthalmic, General-Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-16
• Device Publish Date: 2022-06-08

On-Brand Devices [Fundus Camera]

• 06973211070626: It is an AC-powered device intended to take photographs of the fundus of eye
• 06973211070602: It is an AC-powered device intended to take photographs of the fundus of eye
• 06973211070008: This equipment adopts advanced opto-mechanical and electrical integration technology, and integr
• 06973211071517: SK-680C
• 06973211071500: SK-680B
• 06973211070619: SK-650B