X80 / RADiant / PhotoElectric Therapy System

Basic Information

• Brand Name: X80 / RADiant / PhotoElectric Therapy System
• Primary DI: 05060494200084
• Version / Model: RADiant Aura
• Company Name: XSTRAHL LIMITED
• Labeler DUNS: 491314738
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-08
• Public Version: 1
• Public Version Date: 2024-05-16
• Public Version Status: New
• Public Device Record Key: b7823224-9a59-4d66-966f-4946028c4be3

Device Description

X80 / RADiant / PhotoElectric Therapy System

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JAD	System, Therapeutic, X-Ray	Radiology	892.5900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59233	Stationary orthovoltage therapeutic x-ray system	An assembly of devices designed to produce low-energy x-rays used for therapeutic purposes, primarily in the treatment of skin cancer (e.g., basal cell or squamous cell carcinoma) or other skin conditions (e.g., psoriasis, keloid). The radiation source typically uses a tube voltage of between approximately 100 kV and 500 kV and will be used in conjunction with a variety of topical applicators. The main system is ceiling- or wall-mounted (fixed) in a radiotherapy suite or other clinical setting.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060494200084	GS1

Premarket Submissions

Submission Number	Supplement Number
K230611	000