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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K251808
Device Name Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; and MR 5300 MR Systems
Applicant
Philips Medical Systems Nederland B.V.
Veenpluis 6
Best,  NL 5684PC
Applicant Contact Mehmet Caner Cagdanlioglu
Correspondent
Philips Medical Systems Nederland B.V.
Veenpluis 6
Best,  NL 5684PC
Correspondent Contact Mehmet Caner Cagdanlioglu
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
LNI  
Date Received06/12/2025
Decision Date 07/11/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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