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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K233853
Device Name LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub
Applicant
Philips Medical Systems Nederland B.V.
Veenpluis 6
Best,  NL 5684PC
Applicant Contact Jeanette Becker
Correspondent
Philips Medical Systems Nederland B.V.
Veenpluis 6
Best,  NL 5684PC
Correspondent Contact Jeanette Becker
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Code
DQX  
Date Received12/05/2023
Decision Date 03/14/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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