ChartCheck (RADCH V1.6)
by Radformation, Inc. United States EUDAMED510(k)
510(k) K252988
Product code IYE
Overview
ChartCheck (RADCH V1.6) is a web-based software tool designed for radiology chart review. It consolidates treatment, imaging, and documentation data into a single interface to facilitate comprehensive assessments of patient records during initial, weekly, and end-of-treatment phases.
The device operates as a reusable, non-sterile software solution intended for use in radiology settings. It automates checks, enables continuous monitoring, and provides configurable alerts to streamline chart review processes. Authorized under FDA 510(k) clearance (K252988) and MDR, ChartCheck adheres to regulatory standards for Class 2 radiology devices (product code IYE) and is intended for use in accredited medical facilities.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK252988 | Date5 Jan 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
What is ChartCheck primarily used for in a radiology setting?
ChartCheck is a web-based software tool designed to streamline radiology chart review by consolidating treatment, imaging, and documentation data into one interface. It helps clinicians perform comprehensive assessments of patient records during key phases—initial, weekly, and end-of-treatment—while automating checks and enabling continuous monitoring with configurable alerts.
Is ChartCheck a single-use or reusable software solution, and is it sterile?
ChartCheck is a reusable, non-sterile software tool. Since it operates as a web-based platform, it does not require physical sterilization or single-use disposal, but it must be used in accordance with standard IT security and software maintenance protocols to ensure reliability and data integrity.
How is ChartCheck regulated, and what type of medical facility can use it?
ChartCheck is authorized under both FDA 510(k) clearance (K252988) and the EU’s Medical Device Regulation (MDR). It is classified as a Class 2 radiology device (product code IYE) and is intended for use in accredited medical facilities, such as hospitals or clinics, where radiology chart review is conducted.
Does ChartCheck integrate with specific types of medical equipment or systems?
While ChartCheck itself is a standalone web-based software tool, its design consolidates data from treatment, imaging, and documentation sources. The device’s regulatory submissions reference associations with linear accelerators and other radiology-related equipment (via OpenFDA’s device class and specialty descriptions), suggesting it is intended to complement existing workflows in radiology departments rather than replace standalone hardware.
How can I verify ChartCheck’s regulatory compliance before implementation?
ChartCheck’s compliance is documented through its FDA 510(k) clearance (K252988) and MDR authorization. To verify compliance, you can reference the FDA’s device database using the clearance number or consult Radformation’s official documentation. The device adheres to regulatory standards for Class 2 radiology tools, ensuring it meets safety and performance requirements for accredited medical facilities.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K252988
- EUDAMED