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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name X-Ray, Tomography, Computed, Dental
510(k) Number K193329
Device Name PreXion3D Explorer EX
Applicant
PreXion Corporation
1-14-1, Kanda Suda-cho
Chiyoda-ku,  JP 101-0041
Applicant Contact Hiroaki Takahashi
Correspondent
PreXion Corporation
1-14-1, Kanda Suda-cho
Chiyoda-ku,  JP 101-0041
Correspondent Contact Hiroaki Takahashi
Regulation Number892.1750
Classification Product Code
OAS  
Date Received12/02/2019
Decision Date 04/09/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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