AlignRT Plus

Basic Information

• Brand Name: AlignRT Plus
• Primary DI: 05056190501167
• Version / Model: AlignRT 7.4
• Company Name: VISION RT LIMITED
• Labeler DUNS: 222160801
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-23
• Public Version: 1
• Public Version Date: 2025-12-31
• Public Version Status: New
• Public Device Record Key: e85fa8cd-09fa-413e-a8a0-a13060bcfb06

Device Description

AlignRT 7.4 (NEMA release)

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	05056190501167	GS1

Premarket Submissions

Submission Number	Supplement Number
K233622	000