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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K193243
Device Name Alta Multipurpose Device
Applicant
Qfix
440 Church Rd.
Avondale,  PA  19311
Applicant Contact Alexandra Low Smythe
Correspondent
Qfix
440 Church Rd.
Avondale,  PA  19311
Correspondent Contact Alexandra Low Smythe
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Codes
FRZ   JAI   JAK   KPS   LHN  
LNH   OUO  
Date Received11/25/2019
Decision Date 02/28/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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