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FDA 510(k)

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

K-Number: K234108 · 2024-09-20

ApplicantEnergy Resources International Co., Ltd.
Decision Date2024-09-20
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E) is a medical device manufactured by Energy Resources International Co., Ltd.. It received FDA 510(k) clearance on 2024-09-20 under approval number K234108. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E)?

ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E) is a medical device that received FDA 510(k) clearance on 2024-09-20. It is manufactured by Energy Resources International Co., Ltd.. The 510(k) number is K234108.

When was ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E) approved by the FDA?

ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E) received FDA 510(k) clearance on 2024-09-20, under approval number K234108.

What company makes ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E)?

ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E) is manufactured by Energy Resources International Co., Ltd..

What is the FDA product code for ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E)?

The FDA product code for ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E) is IZL.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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