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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name radiological image processing software for radiation therapy
510(k) Number K193562
Device Name AI-Rad Companion Organs RT
Applicant
Siemens Medical Solutions USA, Inc.
40 Liberty Blvd. Mail Code 65-3
malvern,  PA  19355
Applicant Contact lauren bentley
Correspondent
Siemens Medical Solutions USA, Inc.
40 Liberty Blvd. Mail Code 65-3
malvern,  PA  19355
Correspondent Contact lauren bentley
Regulation Number892.2050
Classification Product Code
QKB  
Date Received12/23/2019
Decision Date 11/06/2020
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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