X80 / RADiant / PhotoElectric Therapy System

GUDID 05060494200084

X80 / RADiant / PhotoElectric Therapy System

XSTRAHL LIMITED

Stationary orthovoltage therapeutic x-ray system

• Primary Device ID: 05060494200084
• NIH Device Record Key: b7823224-9a59-4d66-966f-4946028c4be3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X80 / RADiant / PhotoElectric Therapy System
• Version Model Number: RADiant Aura
• Company DUNS: 491314738
• Company Name: XSTRAHL 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	05060494200084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230611

FDA Product Code

• JAD: System, Therapeutic, X-Ray

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: 2024-05-16
• Device Publish Date: 2024-05-08

Devices Manufactured by XSTRAHL LIMITED

• 05060494200084 - X80 / RADiant / PhotoElectric Therapy System: 2024-05-16X80 / RADiant / PhotoElectric Therapy System
• 05060494200084 - X80 / RADiant / PhotoElectric Therapy System: 2024-05-16 X80 / RADiant / PhotoElectric Therapy System
• 05060494200008 - Xstrahl Photoelectric Therapy System: 2018-03-29 Xstrahl Photoelectric Therapy System
• 05060494200015 - Xstrahl 100 X-Ray System: 2018-03-29 Xstrahl 100 X-Ray System
• 05060494200022 - Xstrahl 150 X-Ray System Floor: 2018-03-29 Xstrahl 150 X-Ray System Floor
• 05060494200039 - Xstrahl 150 X-Ray System - Ceiling: 2018-03-29 Xstrahl 150 X-Ray System - Ceiling
• 05060494200046 - Xstrahl 200 X-Ray System - Floor: 2018-03-29 Xstrahl 200 X-Ray System - Floor
• 05060494200053 - Xstrahl 200 X-Ray System - Ceiling: 2018-03-29 Xstrahl 200 X-Ray System - Ceiling
• 05060494200060 - Xstrahl 300 X-Ray System - Floor: 2018-03-29 Xstrahl 300 X-Ray System - Floor