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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 K210894
Device Name SIDDHARTH-II; IMPACT
Applicant
Panacea Medical Technologies Pvt. , Ltd.
Plot #35, 4th Phase, Malur Kiadb Industrial Area,
Malur-563130, Kolar District, India
Malur, Kolar District,  IN 563130
Applicant Contact Valli G
Correspondent
Panacea Medical Technologies Pvt. , Ltd.
Plot #35, 4th Phase, Malur Kiadb Industrial Area,
Malur-563130, Kolar District, India
Malur, Kolar District,  IN 563130
Correspondent Contact Valli G
Regulation Number892.5050
Classification Product Code
IYE  
Date Received03/25/2021
Decision Date 09/28/2021
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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