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FDA 510(k)

Portable X-ray System Model Ray98(P)

K-Number: K231449 · 2023-07-13

Decision Date2023-07-13
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Portable X-ray System Model Ray98(P) is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Runyes Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2023-07-13 under 510(k) 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. The listed applicant is Ningbo Runyes Medical Instrument Co., Ltd.. The 510(k) number is K231449.

When did Portable X-ray System Model Ray98(P) receive FDA 510(k) clearance?

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

Who is the listed applicant for Portable X-ray System Model Ray98(P)?

The FDA 510(k) record lists Ningbo Runyes Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Ningbo Runyes Medical Instrument Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: EHD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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