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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 K241751
Device Name NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF Seat
Applicant
Positrigo AG
Technoparkstrasse 1
Zürich,  CH 8005
Applicant Contact Jannis Fischer
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number892.1200
Classification Product Code
KPS  
Date Received06/18/2024
Decision Date 07/15/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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