PreXion3D Expedition— 510(k) K232166

Substantially Equivalent

Prexion Corporation

FDA 510(k) clearance K232166 for PreXion3D Expedition, Substantially Equivalent on 2023-09-08. Applicant: Prexion Corporation.

Clearance details

Applicant: Prexion Corporation
Product code: Code OAS
Advisory panel: Radiology
Date received: 2023-07-21
Decision date: 2023-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chiyoda-Ku, JP

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