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FDA 510(k) Applications Submitted by Lauren Bentley
FDA 510(k) Number
Submission Date
Device Name
Applicant
K230886
03/31/2023
Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
Stryker Endoscopy
K171053
04/10/2017
syngo Dynamics Version VA30
Siemens Healthcare GmbH
K161685
06/17/2016
syngo«.via protoNeo (Version VA10A)
SIEMENS HEALTHCARE GMBH
K213713
11/24/2021
AI-Rad Companion (Pulmonary)
Siemens Healthcare GmBh
K193283
11/27/2019
AI-Rad Companion Prostate MR
Siemens Medical Solutions USA Inc.
K193290
11/27/2019
AI-Rad Companion Brain MR
Siemens Medical Solutions USA, Inc.
K193294
11/27/2019
AI-Rad Companion Engine
Siemens Medical Solutions USA, Inc.
K193562
12/23/2019
AI-Rad Companion Organs RT
Siemens Medical Solutions USA, Inc.
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