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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cabinet, x-ray system
510(k) Number K173309
Device Name Faxitron VisionCT
Applicant
Faxitron Bioptics Llc
3440 E. Britannia Dr.
Suite 150
Tucson,  AZ  85706
Applicant Contact Douglas C. Wiegman
Correspondent
Faxitron Bioptics Llc
3440 E. Britannia Dr.
Suite 150
Tucson,  AZ  85706
Correspondent Contact Douglas C. Wiegman
Regulation Number892.1680
Classification Product Code
MWP  
Date Received10/18/2017
Decision Date 05/09/2018
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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