ClearCalc Model RADCA V2
by Radformation, Inc. United States EUDAMED510(k)
510(k) K220582
Product code MUJ
Overview
The ClearCalc Model RADCA V2 is a System, Planning, Radiation Therapy Treatment device, classified as a Class II medical device. It is designed to assist in the planning and optimization of radiation therapy treatment by providing precise dose calculations and assessments, ensuring accurate and efficient treatment delivery for patients.
This software-based device is intended for use in radiology settings and has received FDA 510(k) clearance and MDR authorization. It operates as a reusable digital tool, requiring no sterility considerations. The device is supplied as a standalone software solution and is regulated under the radiation therapy planning category (regulation number 892.5050). No specific MRI safety or physical size constraints are noted in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK220582 | Date22 Aug 2022 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- MUJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Radformation, Inc.
Questions
What is the primary purpose of the ClearCalc Model RADCA V2 in a clinical setting?
The ClearCalc Model RADCA V2 is a software-based radiation therapy planning system designed to assist radiology teams in optimizing and calculating precise radiation dose distributions for patient treatments. It helps ensure accurate and efficient delivery of radiation therapy by providing detailed dose assessments during the planning phase.
Is the ClearCalc Model RADCA V2 a single-use or reusable device, and do I need to worry about sterility?
The ClearCalc Model RADCA V2 is a reusable digital tool, meaning it is not intended for single-use. Since it is software-based and does not come into direct contact with patients or sterile environments, sterility considerations do not apply to this device.
How is the ClearCalc Model RADCA V2 supplied, and what kind of setup is required?
The ClearCalc Model RADCA V2 is supplied as a standalone software solution, meaning it does not require physical hardware beyond standard computing infrastructure. It is intended to be integrated into existing radiology systems for radiation therapy planning, with no additional physical components or sterility requirements.
What regulatory pathways has the ClearCalc Model RADCA V2 followed, and where can I find more details?
The ClearCalc Model RADCA V2 has received FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, confirming its compliance with U.S. and European regulatory standards. The device is classified under the radiation therapy planning category (regulation number 892.5050) and was reviewed by the Radiology (RA) advisory committee. For further details, you can reference the FDA’s OpenFDA database using the registration numbers or the applicant’s contact information provided.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K220582
- EUDAMED