Intraoperative Radiation Therapy Devices

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K891261 ↗

FDA Product Code

LHN

Device Class

Class II

Regulation

21 CFR Part 892.5050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Generator, High Volt, X-Ray, Diag. MPX80

  Class I

  FDA 510(k) K802548 Active Cleared 2 Dec 1980

• Senograph Ds, Senograph Essenstial

  Class II

  FDA 510(k) K103485 Active Cleared 6 Oct 2011

• Senographe Ds, Senographe Essential

  Class II

  FDA 510(k) K110798 Active Cleared 22 Dec 2011

• GE CT/T 8800 System

  Class II

  FDA 510(k) K780326 Active Cleared 14 Mar 1978

• CT Pace Catalog Number B7950A

  Class II

  FDA 510(k) K872526 Active Cleared 23 Sep 1987

• Series 620 Rectal Probe Cover

  Class II

  FDA 510(k) K864222 Active Cleared 4 Mar 1987

See all devices from General Electric Co. →

• What is the primary purpose of these intraoperative radiation therapy devices, and where are they typically used in a clinical setting?

  These devices are designed to deliver high-energy charged particles (like electrons or protons) directly to tumors during surgery, allowing precise radiation treatment while the patient is still under anesthesia. They integrate advanced components such as treatment planning software and patient positioning supports, making them ideal for radiology departments where complex, targeted tumor therapies are performed.

• Are these devices single-use or reusable, and what maintenance or handling considerations should be kept in mind?

  These devices are not single-use and are built for repeated use in controlled clinical environments. Since they are complex systems, they require specialized training for operation and maintenance. While no specific sterility or storage conditions are noted beyond standard medical device protocols, proper handling and adherence to regulatory standards are essential to ensure safe and effective performance.

• How are these devices regulated in the U.S., and what does the FDA classification mean for their use?

  These devices are regulated under the FDA’s 510(k) clearance process and are classified as Class II medical devices. The clearance (K891261) indicates they are deemed substantially equivalent to a predicate device, meaning they meet FDA standards for safety and effectiveness. This classification ensures they undergo rigorous review by the Radiology Advisory Committee before approval, ensuring their use in intraoperative radiation therapy is well-documented and compliant with regulatory requirements.

• Can these devices be used in conjunction with MRI equipment, or are there any compatibility concerns?

  The device data explicitly states these systems are not inherently MRI-compatible, meaning they should not be used in environments where MRI is performed or where magnetic fields are present. Clinicians should verify compatibility with their specific MRI systems before integrating these devices into a multi-modal treatment plan.

• What types of facilities or departments would typically house or operate these devices, and why?

  These devices are intended for use in radiology departments within hospitals or specialized cancer centers. Their integration of radiation therapy with surgical procedures requires a setting equipped to handle high-energy particle delivery, advanced imaging, and precise patient positioning—all of which align with the capabilities of radiology units. The advisory committee classification (Radiology) further confirms their intended use in this clinical specialty.