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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 K230312
Device Name Iris AirShuttle™
Applicant
Qfix
440 Church Rd.
Avondale,  PA  19311
Applicant Contact McKenzie Banasik
Correspondent
Qfix
440 Church Rd.
Avondale,  PA  19311
Correspondent Contact McKenzie Banasik
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Codes
FRZ   IZI   JAI   JAK   KPS  
LHN   LNH   OUO   OWB  
Date Received02/03/2023
Decision Date 03/31/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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