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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 K222762
Device Name SIDDHARTH-II;IMPACT
Applicant
Panacea Medical Technologies Pvt. , Ltd.
Plot # 35, 4th Phase, Malur Kiadb Industrial Area
Kolar District
Malur,  IN 563130
Applicant Contact Valli G.
Correspondent
Panacea Medical Technologies Pvt. , Ltd.
Plot # 35, 4th Phase, Malur Kiadb Industrial Area
Kolar District
Malur,  IN 563130
Correspondent Contact Valli G.
Regulation Number892.5050
Classification Product Code
IYE  
Date Received09/13/2022
Decision Date 06/08/2023
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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