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FDA 510(k)

Portable X-ray System Model Ray98(P)

K-Number: K231449 · 2023-07-13

ApplicantNingbo Runyes Medical Instrument Co., Ltd.
Decision Date2023-07-13
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Portable X-ray System Model Ray98(P) is a medical device manufactured by Ningbo Runyes Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2023-07-13 under approval number K231449. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Portable X-ray System Model Ray98(P)?

Portable X-ray System Model Ray98(P) is a medical device that received FDA 510(k) clearance on 2023-07-13. It is manufactured by Ningbo Runyes Medical Instrument Co., Ltd.. The 510(k) number is K231449.

When was Portable X-ray System Model Ray98(P) approved by the FDA?

Portable X-ray System Model Ray98(P) received FDA 510(k) clearance on 2023-07-13, under approval number K231449.

What company makes Portable X-ray System Model Ray98(P)?

Portable X-ray System Model Ray98(P) is manufactured by Ningbo Runyes Medical Instrument Co., Ltd..

What is the FDA product code for Portable X-ray System Model Ray98(P)?

The FDA product code for Portable X-ray System Model Ray98(P) is EHD.

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Other Devices by Ningbo Runyes Medical Instrument Co., Ltd.

K252909Diagnostic X-Ray Equipment Model POCT22

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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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