EXL-22DP X-Ray Radiation Therapy System
510(k) K873398
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK873398 | Date29 Apr 1988 | 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- Withdrawn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 EXL-22DP X-Ray Radiation Therapy System is a linear accelerator (LINAC) designed for external beam radiotherapy. It delivers high-energy X-ray radiation to treat malignant and benign conditions through precise targeting of tumours or lesions, enabling controlled dose delivery for cancer therapy and other radiotherapeutic applications.
This system is intended for use in radiology departments within hospital settings and is classified as a Class II medical device. It is supplied as a reusable, non-sterile device, with regulatory clearance under FDA 510(k) (K873398) as substantially equivalent to predicate devices. The system operates within MRI-unsafe environments and requires proper maintenance, calibration, and storage in designated radiation therapy facilities.
Other devices from Mitsubishi Intl. Corp.
Questions
AI-generated answers, 19 Sep 2026
What types of medical conditions is the EXL-22DP X-Ray Radiation Therapy System primarily used to treat?
The EXL-22DP is designed for external beam radiotherapy to treat malignant and benign conditions by delivering high-energy X-ray radiation. It is specifically intended for precise targeting of tumors or lesions, making it suitable for cancer therapy and other radiotherapeutic applications in hospital radiology departments.
Is the EXL-22DP X-Ray Radiation Therapy System reusable or single-use, and what does that mean for maintenance?
The EXL-22DP is supplied as a reusable device, meaning it is not intended for single-use disposal. This classification implies that it requires regular maintenance, calibration, and cleaning to ensure proper functionality and safety in clinical settings. Hospitals must follow manufacturer guidelines for upkeep to maintain compliance and performance.
Can the EXL-22DP be used in areas where MRI equipment is present, and why?
No, the EXL-22DP is not designed for use in MRI-safe environments. The system operates in MRI-unsafe settings due to its high-energy X-ray radiation and electromagnetic properties, which could interfere with MRI compatibility or pose safety risks to patients and staff in combined environments.
How is the EXL-22DP X-Ray Radiation Therapy System regulated in the U.S., and what does that mean for purchasing hospitals?
The EXL-22DP holds FDA 510(k) clearance (K873398) as a Class II medical device, determined to be substantially equivalent to predicate devices. This means hospitals must ensure compliance with FDA regulations, including proper installation, training for staff, and adherence to maintenance protocols outlined by Mitsubishi International Corp. to operate the system legally and safely.
Where should the EXL-22DP be stored, and are there any specific environmental requirements?
The EXL-22DP must be stored in designated radiation therapy facilities, as specified by Mitsubishi International Corp. Since it is a reusable, non-sterile device, storage should follow manufacturer guidelines to protect against contamination, environmental damage, and unauthorized access. Proper ventilation and secure housing are critical to maintain functionality and safety.