K234108

ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E)

510(k) number: K234108
Device name: ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E)
Applicant: Energy Resources International Co., Ltd. TW
Product code: IZL — System, X-Ray, Mobile
Decision date: 2024-09-20
Date received: 2023-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Radiology

Also available from FDA: K234108.pdf

Official FDA record: K234108

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.