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FDA 510(k)

Ai Ray Dental X-Ray Device

K-Number: K222569 · 2022-11-23

Decision Date2022-11-23
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Ai Ray Dental X-Ray Device is the device name listed in this FDA 510(k) record. The listed applicant is Guilin Woodpecker Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2022-11-23 under 510(k) number K222569. 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 Ai Ray Dental X-Ray Device?

Ai Ray Dental X-Ray Device is a medical device that received FDA 510(k) clearance on 2022-11-23. The listed applicant is Guilin Woodpecker Medical Instrument Co., Ltd.. The 510(k) number is K222569.

When did Ai Ray Dental X-Ray Device receive FDA 510(k) clearance?

Ai Ray Dental X-Ray Device received FDA 510(k) clearance on 2022-11-23, under 510(k) number K222569.

Who is the listed applicant for Ai Ray Dental X-Ray Device?

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

What is the FDA product code for Ai Ray Dental X-Ray Device?

The FDA product code for Ai Ray Dental X-Ray Device is EHD.

Other records listing Guilin Woodpecker 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.

View all 11 devices →

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