PreXion3D Explorer EX— 510(k) K193329

Substantially Equivalent

Prexion Corporation

FDA 510(k) clearance K193329 for PreXion3D Explorer EX, Substantially Equivalent on 2020-04-09. Applicant: Prexion Corporation.

Clearance details

Applicant: Prexion Corporation
Product code: Code OAS
Advisory panel: Radiology
Date received: 2019-12-02
Decision date: 2020-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chiyoda-Ku, JP

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