ERI Portable X-ray System (CVX-air); CVX-lite; CVX-E
by Energy Resources International Co., Ltd.
510(k) K234108
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK234108 | Date20 Sep 2024 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E)
- 510(k) Number
- FDA Product Code
- IZL
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1720
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The ERI Portable X-ray System (CVX-air, CVX-lite, CVX-E) is a mobile X-ray imaging device classified as a System, X-Ray, Mobile under FDA regulation 892.1720. These systems are designed to generate X-ray images of extremities using computed radiography, providing portable diagnostic imaging capabilities for radiology applications. Each variant (CVX-air, CVX-lite, CVX-E) is engineered for field or point-of-care use, ensuring flexibility in clinical settings where stationary equipment may not be feasible.
The systems are supplied as reusable medical devices, intended for use in radiology departments, emergency settings, or remote locations. They are not sterile and require proper maintenance and calibration per manufacturer guidelines. All variants comply with FDA 510(k) clearance (K234108) under the Radiology Advisory Committee, with a decision of Substantially Equivalent (SESE). Storage and handling must adhere to regulatory and safety standards to ensure optimal performance and patient safety.
Questions
AI-generated answers, 1 Oct 2026
What is the ERI Portable X-ray System (CVX-air/lite/E) used for?
This system is designed specifically for generating X-ray images of extremities using computed radiography. It is intended for use in radiology departments, emergency settings, or remote locations where stationary X-ray equipment is impractical. The portable design ensures flexibility for on-site imaging, particularly for limbs or small body parts.
Are the ERI Portable X-ray Systems (CVX-air/lite/E) single-use or reusable?
These systems are reusable medical devices. They are not intended for single-use and require proper maintenance, calibration, and cleaning per the manufacturer’s guidelines to ensure consistent performance and patient safety. Reusability extends their utility in clinical environments where disposable alternatives may not be cost-effective.
Do the ERI Portable X-ray Systems come sterile?
No, the ERI Portable X-ray Systems (CVX-air, CVX-lite, CVX-E) are not sterile. They are designed for reusable applications in controlled environments like radiology departments or emergency settings. Sterility is not required for their intended use, but they must be handled and maintained according to regulatory and manufacturer guidelines to prevent contamination.
What regulatory approval does the ERI Portable X-ray System hold?
The ERI Portable X-ray System (CVX-air/lite/E) holds FDA 510(k) clearance (K234108) under the Radiology Advisory Committee. The decision was classified as *Substantially Equivalent (SESE)*, meaning it meets the same performance criteria as a legally marketed predicate device. This clearance applies to all three variants (CVX-air, CVX-lite, CVX-E) as mobile X-ray systems under FDA regulation 892.1720.
How should the ERI Portable X-ray Systems be stored?
Storage must comply with regulatory and safety standards to ensure optimal performance and patient safety. The systems should be kept in a clean, dry environment protected from physical damage, extreme temperatures, and direct sunlight. Regular calibration and maintenance checks are also required to verify functionality before use. Follow the manufacturer’s instructions for specific storage recommendations.