Identifiers
- 510(k) Number
- K241713 FDA 510(k)
- FDA Product Code
- JAK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1750 FDA 510(k)
- Regulation Number
- 892.1750 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The HiRise (1040-230) is a mobile computed radiography (CR) system designed for portable X-ray imaging. It provides high-resolution radiographic images, enabling real-time diagnostic imaging in various clinical settings where traditional fixed X-ray systems are impractical.
This device is intended for single-use or reusable applications in radiology departments, emergency rooms, and other clinical environments requiring portable imaging solutions. Supplied sterile or non-sterile as specified by the manufacturer, it adheres to FDA 510(k) clearance under Special Review (K241713) and EU MDR compliance. The system is classified under product code JAK and is intended for use in radiography procedures, with no specific MRI safety classification indicated.
Frequently asked questions
What clinical settings is the HiRise (1040-230) designed to support for portable X-ray imaging?
The HiRise (1040-230) is specifically engineered for environments where fixed X-ray systems are impractical, such as radiology departments, emergency rooms, and other clinical areas requiring mobility. Its portable design enables high-resolution radiographic imaging on-site, making it ideal for acute care, trauma settings, or locations where patient transport for imaging is challenging.
How is the HiRise (1040-230) supplied, and can it be reused or is it single-use?
The HiRise (1040-230) is designed for both single-use and reusable applications, depending on the clinical workflow and manufacturer specifications. Sterility (sterile or non-sterile) is configurable per use case, allowing flexibility for different procedural needs. This dual-use capability ensures adaptability in settings ranging from sterile surgical environments to routine diagnostic imaging.
What regulatory pathways does the HiRise (1040-230) follow for FDA and EU compliance?
The HiRise (1040-230) has received FDA 510(k) clearance under Special Review (K241713) and complies with EU MDR (Medical Device Regulation). The device is classified under product code JAK for radiography procedures, with no MRI safety classification specified. This dual compliance ensures it meets both U.S. and European regulatory standards for portable computed radiography systems.
Is there a specific advisory committee or review panel associated with the FDA submission for this device?
Yes, the HiRise (1040-230) was reviewed by the Radiology (RA) Advisory Committee as part of its FDA 510(k) submission process. This committee provides expert input on radiology-related devices, ensuring the HiRise meets safety and performance standards for portable imaging applications. The submission was classified as Substantially Equivalent (SESE) under the Special Review pathway.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K241713 | Class II | Active |
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Manufacturer
- Manufacturer
- CurveBeam LLC
- FDA Applicant
- Curvebeam, LLC
Sources (2)
- FDA 510(k) K241713 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026