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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 K250392
Device Name ZAP-X Radiosurgery System (ZAP-X)
Applicant
Zap Surgical Systems, Inc.
590 Taylor Way
San Carlos,  CA  94070
Applicant Contact Junyi Wang
Correspondent
Zap Surgical Systems, Inc.
590 Taylor Way
San Carlos,  CA  94070
Correspondent Contact Junyi Wang
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Code
MUJ  
Date Received02/12/2025
Decision Date 11/03/2025
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		 Yes
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