ClearCheck RADCC V2.7
by Radformation, Inc. United States EUDAMED510(k)
510(k) K253962
Product code IYE
Overview
The ClearCheck RADCC V2.7 is a medical linear accelerator, classified as a Class II device under FDA regulations. It is designed for high-energy radiation therapy, delivering precise photon and electron beams for the treatment of cancer and other radiotherapeutic indications in clinical oncology settings.
This device is supplied as a reusable, non-sterile medical instrument intended for use in radiation oncology departments. It operates within MRI-unsafe environments and is regulated under FDA 510(k) clearance (K253962) and the EU Medical Device Regulation (MDR). The device adheres to regulatory standards for radiation safety and performance, including compliance with 21 CFR 892.5050, and is distributed by Radformation, Inc.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK253962 | Date3 Apr 2026 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Not covered
- European Union
- United States
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
Other devices from Radformation, Inc.
Questions
Is the ClearCheck (RADCC V2.7) designed for single-use or can it be reused in a clinical setting?
The ClearCheck (RADCC V2.7) is explicitly described as a reusable medical linear accelerator. It is supplied as a non-sterile instrument intended for repeated use in radiation oncology departments, adhering to regulatory standards for radiation safety and performance.
What types of radiation beams does the ClearCheck (RADCC V2.7) deliver, and what are its primary clinical applications?
The ClearCheck (RADCC V2.7) is designed to deliver high-energy photon and electron beams for radiation therapy. Its primary use is in clinical oncology settings, where it treats cancer and other radiotherapeutic indications by providing precise radiation delivery.
How is the ClearCheck (RADCC V2.7) regulated, and what does its classification mean for purchasing or implementation?
The ClearCheck (RADCC V2.7) is classified as a Class II device under FDA regulations and has received FDA 510(k) clearance (K253962). It is also compliant with the EU Medical Device Regulation (MDR). This classification indicates it undergoes stricter scrutiny than Class I devices but does not require the same rigorous oversight as Class III. The device is distributed by Radformation, Inc., and adheres to radiation safety standards like 21 CFR 892.5050, ensuring its suitability for use in radiation oncology departments.
Can the ClearCheck (RADCC V2.7) be used in environments where MRI equipment is present, and why?
No, the ClearCheck (RADCC V2.7) is not MRI-safe and is explicitly designed for use in MRI-unsafe environments. This is because the device operates using high-energy radiation and electromagnetic components that could interfere with MRI systems or pose safety risks in an MRI setting.
What should I consider regarding storage and maintenance of the ClearCheck (RADCC V2.7) in a clinical setting?
While the device data does not specify storage conditions, the ClearCheck (RADCC V2.7) is a reusable, non-sterile medical linear accelerator. Clinicians should follow manufacturer guidelines for proper cleaning, calibration, and maintenance protocols to ensure optimal performance and safety. Since it operates in radiation oncology, adherence to regulatory standards like 21 CFR 892.5050 will also be critical for ongoing compliance and safe operation.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K253962
- EUDAMED