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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Therapeutic, X-Ray
510(k) Number K213942
Device Name Esteya
Applicant
Nucletron B.V.
3900 Ax Veenendaal, P.O. Box 930, Waardgelder 1
Veenendaal,  NL 3905 TH
Applicant Contact Kiran Jose
Correspondent
Nucletron B.V.
3900 Ax Veenendaal, P.O. Box 930, Waardgelder 1
Veenendaal,  NL 3905 TH
Correspondent Contact Kiran Jose
Regulation Number892.5900
Classification Product Code
JAD  
Date Received12/17/2021
Decision Date 01/11/2022
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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