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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K213713
Device Name AI-Rad Companion (Pulmonary)
Applicant
Siemens Healthcare GmBh
40 Liberty Blvd. Mail Code 65-1
Malvern,  PA  19355
Applicant Contact Lauren Bentley
Correspondent
Siemens Healthcare GmBh
40 Liberty Blvd.
Malvern,  PA  19355
Correspondent Contact Kira Kuzmenchuk
Regulation Number892.1750
Classification Product Code
JAK  
Subsequent Product Code
QIH  
Date Received11/24/2021
Decision Date 08/11/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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