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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 K183142
Device Name PathVisionXL
Applicant
Faxitron Bioptics, LLC
3440 E. Britannia Dr., Suite 150
Tucson,  AZ  85706
Applicant Contact Ciaran Purdy
Correspondent
Faxitron Bioptics, LLC
3440 E. Britannia Dr., Suite 150
Tucson,  AZ  85706
Correspondent Contact Ciaran Purdy
Regulation Number892.1680
Classification Product Code
MWP  
Date Received11/13/2018
Decision Date 03/14/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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