SKANRAD 400

GUDID 08904269409531

Skanrad 400 is an advanced high frequency type X-ray system designed for superior image quality for radiographic use with powerful 32 kW generator and very low X-ray leakage radiation

SKANRAY TECHNOLOGIES LIMITED

Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 08904269409531
• NIH Device Record Key: 3b2edb02-0c38-4b39-a52f-c87b1efcb310
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SKANRAD 400
• Version Model Number: 303-000783-4
• Company DUNS: 863358955
• Company Name: SKANRAY TECHNOLOGIES LIMITED
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08904269409531 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220518

FDA Product Code

• KPR: System, X-Ray, Stationary

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: 2022-05-19
• Device Publish Date: 2022-05-11

Devices Manufactured by SKANRAY TECHNOLOGIES LIMITED

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