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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K253690
Device Name LungMaps
Applicant
Siemens Healthineers AG
Siemensstr. 3
Forchheim,  DE 91301
Applicant Contact Friederike Hertle
Correspondent
Siemens Medical Solutions USA, Inc.
40 Liberty Blvd.
Malvern,  PA  19355
Correspondent Contact Milind Dhamankar
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LNH  
Date Received11/21/2025
Decision Date 06/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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