AlignRT Plus

Basic Information

• Brand Name: AlignRT Plus
• Primary DI: 05056190500481
• Version / Model: Horizon camera
• Company Name: VISION RT LIMITED
• Labeler DUNS: 222160801
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-23
• Public Version: 2
• Public Version Date: 2022-12-15
• Public Version Status: Update
• Public Device Record Key: 6e849740-8167-47c0-88b6-46582bf13608

Device Description

Horizon camera pod

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
IYE	Accelerator, Linear, Medical	Radiology	892.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47816	Radiological video camera patient positioning/tracking system	An assembly of hardware and software devices intended to use light-based (e.g., infrared, visible light) image acquisition to create three-dimensional (3-D) surfaces of a patient anatomy (e.g., head) to monitor patient position during diagnostic imaging, radiation treatment planning, and/or radiation therapy without the use of patient markers. It includes a camera(s), workstation, and appropriate software.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05056190500481	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K203387	000