FDA 510(k)

Dental Cone-beam Computed Tomography (mDX-15P Series)

K-번호: K261748 · 2026-07-23

신청자Hefei Meyer Optoelectronic Technology, Inc.

결정일2026-07-23

제품 코드OAS

자문 위원회RA

결정Substantially Equivalent

기기 요약

Dental Cone-beam Computed Tomography (mDX-15P Series) is the device name listed in this FDA 510(k) record. The listed applicant is Hefei Meyer Optoelectronic Technology, Inc.. It received FDA 510(k) clearance on 2026-07-23 under 510(k) number K261748. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Dental Cone-beam Computed Tomography (mDX-15P Series)?

Dental Cone-beam Computed Tomography (mDX-15P Series) is a medical device that received FDA 510(k) clearance on 2026-07-23. The listed applicant is Hefei Meyer Optoelectronic Technology, Inc.. The 510(k) number is K261748.

When did Dental Cone-beam Computed Tomography (mDX-15P Series) receive FDA 510(k) clearance?

Dental Cone-beam Computed Tomography (mDX-15P Series) received FDA 510(k) clearance on 2026-07-23, under 510(k) number K261748.

Who is the listed applicant for Dental Cone-beam Computed Tomography (mDX-15P Series)?

The FDA 510(k) record lists Hefei Meyer Optoelectronic Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Cone-beam Computed Tomography (mDX-15P Series)?

The FDA product code for Dental Cone-beam Computed Tomography (mDX-15P Series) is OAS.

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Dental Cone-beam Computed Tomography (mDX-15P Series)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: OAS)

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