PreXion3D Explorer PRO— 510(k) K221525

Substantially Equivalent

Prexion Corporation

FDA 510(k) clearance K221525 for PreXion3D Explorer PRO, Substantially Equivalent on 2022-07-22. Applicant: Prexion Corporation.

Clearance details

Applicant: Prexion Corporation
Product code: Code OAS
Advisory panel: Radiology
Date received: 2022-05-26
Decision date: 2022-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chiyoda-Ku, JP

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