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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 K183698
Device Name Zap-X Radiosurgery System
Applicant
Zap Surgical Systems
590 Taylor Way
San Carlos,  CA  94070
Applicant Contact Jim Talbot
Correspondent
Zap Surgical Systems
590 Taylor Way
San Carlos,  CA  94070
Correspondent Contact Jim Talbot
Regulation Number892.5050
Classification Product Code
IYE  
Date Received12/31/2018
Decision Date 02/25/2019
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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