MU Plus
by Rad Therapy Solutions, Inc.
510(k) K992689
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK992689 | Date10 Feb 2000 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IYE
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The MU Plus is a Linear Accelerator, Medical, designed for radiation therapy planning and dose measurement in radiology. It provides monitoring of monitor units (MU) to ensure accurate delivery of radiation doses during treatment, supporting precision in external beam radiotherapy.
This device is intended for use in radiology departments and requires proper training for operation. Supplied as a reusable instrument, it is not sterile and must be cleaned and maintained according to manufacturer guidelines. The MU Plus is classified as a Class II device under FDA regulations (product code IYE) and holds a Traditional 510(k) clearance (K992689) issued in February 2000. Compliance with regulatory standards ensures its safe integration into clinical workflows.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the MU Plus in a clinical setting?
The MU Plus is designed specifically for radiation therapy planning and dose measurement in radiology. It monitors monitor units (MU) to ensure precise delivery of radiation doses during external beam radiotherapy, helping to maintain accuracy and consistency in treatment.
Is the MU Plus a single-use or reusable device, and what maintenance is required?
The MU Plus is a reusable instrument and is not sterile. It must be cleaned and maintained according to the manufacturer’s guidelines to ensure proper functionality and safety in clinical use.
How is the MU Plus regulated, and what does its classification mean for clinical use?
The MU Plus holds a Traditional 510(k) clearance (K992689) from the FDA and is classified as a Class II device under product code IYE. This classification indicates it has been determined to be substantially equivalent to a legally marketed device, ensuring it meets regulatory standards for safe and effective use in radiology departments.
What type of training is required to operate the MU Plus?
The MU Plus is intended for use in radiology departments and requires proper training for operation, as outlined by the manufacturer. This ensures clinicians can accurately monitor and deliver radiation doses during treatment.
Where can I find more information about the regulatory history or compliance of the MU Plus?
The MU Plus was submitted to the FDA under the Radiology advisory committee (RA) and received a Traditional 510(k) clearance in February 2000. For detailed regulatory documentation, including the clearance number (K992689) and compliance records, you can reference the FDA’s openFDA database or contact Rad Therapy Solutions, Inc. at 738 Alden Dr., Ormond Beach, FL 32176.