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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K253844
Device Name AnyScan 3.0 NM Scanner Family
Applicant
Mediso Medical Imaging Systems, Ltd.
Laborc Utca 3.
Budapest,  HU H-1037
Applicant Contact Daniel Cser
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received12/02/2025
Decision Date 12/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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