FDA · official record K261748Substantially Equivalent

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

Name: Dental Cone-beam Computed Tomography (mDX-15P Series) — FDA K261748
Creator: Hefei Meyer Optoelectronic Technology, Inc.
Keywords: Dental Cone-beam Computed Tomography (mDX-15P Series), Dental Cone-beam Computed Tomography (mDX-15P Series), K261748, OAS, FDA

United StatesOASHefei Meyer Optoelectronic Technology, Inc.

Verified

Official record identity

FDA application number: K261748
Decision date: July 23, 2026
Published decision: Substantially Equivalent

Classification

Product code: OAS

Published parties

Applicant: Hefei Meyer Optoelectronic Technology, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2026-05-28
Review panel: Radiology
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 892.1750

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.