FDA · official record K240855Substantially Equivalent

Dental Cone-beam Computed Tomography

Name: Dental Cone-beam Computed Tomography — FDA K240855
Creator: Yian Medical Technology (Haining) Co., Ltd.
Keywords: Dental Cone-beam Computed Tomography, Dental Cone-beam Computed Tomography, K240855, OAS, FDA

United StatesOASYian Medical Technology (Haining) Co., Ltd.

Verified

Official record identity

FDA application number: K240855
Decision date: April 25, 2024
Published decision: Substantially Equivalent

Classification

Product code: OAS

Published parties

Applicant: Yian Medical Technology (Haining) Co., Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 2024-03-28
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.