Collision Check
by Radformation, Inc. United States 510(k)
510(k) K171350
Product code IYE
Overview
The Collision Check is a software tool designed as a Radiation Treatment Planning System (RTPS) accessory to detect and prevent collisions between linear accelerators and patient support systems during radiotherapy treatment planning. It functions as an automated verification system to enhance safety by identifying potential physical obstructions that could interfere with treatment delivery.
This device operates within a radiation oncology workflow, integrating with treatment planning systems to analyze geometric and positional data of accelerators, couches, and accessories. Supplied as a software-only solution, it requires no sterilization or physical handling, ensuring compatibility with existing RTPS environments. The tool adheres to FDA 510(k) clearance (K171350) under regulatory classification IYE, with no specified sterility or MRI safety constraints. It is intended for single-use per treatment plan review, though the underlying software may be reused across multiple sessions.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK171350 | Date29 Nov 2017 | StatusActive |
Coverage
- Active
- 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
Other devices from Radformation, Inc.
Questions
What is the primary purpose of the Collision Check software tool in radiotherapy treatment planning?
The Collision Check is designed to detect and prevent physical collisions between linear accelerators and patient support systems during radiotherapy treatment planning. It integrates with Radiation Treatment Planning Systems (RTPS) to analyze geometric and positional data, ensuring safe treatment delivery by identifying potential obstructions before they occur.
Is the Collision Check software reusable across multiple treatment plans, or is it intended for single-use?
The software itself is reusable across multiple treatment sessions, but it is intended for single-use per individual treatment plan review. This means you can run the tool repeatedly to verify different plans, but it doesn’t require re-installation or re-activation for each use.
How is the Collision Check supplied, and does it require any special handling or sterilization?
The Collision Check is supplied as a software-only solution, meaning there are no physical components to handle or sterilize. Since it operates digitally within existing RTPS environments, no sterilization or physical preparation is needed—just installation and integration with your current systems.
Does the Collision Check have any compatibility limitations with specific linear accelerator models or treatment planning systems?
While the device is designed to integrate with Radiation Treatment Planning Systems (RTPS) and works with linear accelerators, the exact compatibility depends on the specific RTPS and accelerator models in use. The FDA clearance references multiple linear accelerator models (via OpenFDA), but final integration should be verified with your facility’s existing equipment and Radformation’s technical support.
How was the Collision Check’s regulatory pathway determined, and what does that mean for its use in clinical settings?
The Collision Check received FDA 510(k) clearance under the classification IYE, determined to be *substantially equivalent* to a predicate device. This means the FDA reviewed it as a traditional submission through the Radiology Advisory Committee (RA) and concluded it meets safety and effectiveness standards for its intended use—automated collision detection in radiotherapy planning. Clinically, this clearance indicates it’s been evaluated for safety and performance in its designated workflow.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K171350