PreXion3D Excelsior— 510(k) K173878

Substantially Equivalent

Prexion Corporation

FDA 510(k) clearance K173878 for PreXion3D Excelsior, Substantially Equivalent on 2018-01-19. Applicant: Prexion Corporation. Device class: 2.

Clearance details

Applicant
Prexion Corporation
Product code
Code OAS
Device class
Class 2
Regulation
21 CFR 892.1750
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Chiyoda-Ku, JP
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