Yushan

GUDID 04719879300062

INNOCARE OPTOELECTRONICS CORPORATION

Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 04719879300062
• NIH Device Record Key: 63dc7e75-de08-42ae-9de7-a2ed7d0165cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Yushan
• Version Model Number: F14C
• Company DUNS: 658742829
• Company Name: INNOCARE OPTOELECTRONICS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719879300062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210988

FDA Product Code

• MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)

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: 2021-05-03
• Device Publish Date: 2021-04-23

On-Brand Devices [Yushan]

• 04719879300079: F14G
• 04719879300062: F14C
• 04719879300086: V17Ce