FDA · official record K221525Substantially Equivalent

PreXion3D Explorer PRO

Name: PreXion3D Explorer PRO — FDA K221525
Creator: Prexion Corporation
Keywords: PreXion3D Explorer PRO, PreXion3D Explorer PRO, K221525, OAS, FDA

United StatesOASPrexion Corporation

Verified

Official record identity

FDA application number: K221525
Decision date: July 22, 2022
Published decision: Substantially Equivalent

Classification

Product code: OAS

Published parties

Applicant: Prexion Corporation

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2022-05-26
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.