ClearanceBrief
Company · DE

Siemens Healthcare GmbH

FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2026. Name variants (Inc, Corp, punctuation) are merged.

33510(k) clearances (5 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
LLZSystem, Image Processing, Radiological15
QIHAutomated Radiological Image Processing Software5
JAKSystem, X-Ray, Tomography, Computed3
LNHSystem, Nuclear Magnetic Resonance Imaging2
OEBLung Computed Tomography System, Computer-Aided Detection2
QKBRadiological Image Processing Software For Radiation Therapy2
QTZRadiological Image Processing Software For Ablation Therapy Planning And Evaluation2
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic1
QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jun 16, 2026K253264myAblation Guide (VC10A)
Siemens Healthcare GmbH, DE
QTZ
Apr 10, 2026K253689syngo Dynamics (VA41F)
Siemens Healthcare GmbH, DE
QIH
Apr 10, 2026K252548AI-Rad Companion Organs RT
Siemens Healthcare GmbH, DE
QKB
Jan 22, 2026K253057AI-Rad Companion Brain MR
Siemens Healthcare GmbH, DE
QIH
Dec 19, 2025K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida F
Siemens Healthcare GmbH, DE
LNH
Sep 9, 2025K252608AI-Rad Companion Prostate MR
Siemens Healthcare GmbH, DE
LLZ
Jun 16, 2025K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile
Siemens Healthcare GmbH, DE
LNH
Apr 3, 2025K242551syngo Dynamics (Version VA41D)
Siemens Healthcare GmbH, DE
QIH
Mar 27, 2025K242745AI-Rad Companion Organs RT
Siemens Healthcare GmbH, DE
QKB
Mar 5, 2025K241770Prostate MR AI (VA10A)
Siemens Healthcare GmbH, DE
QDQ
Aug 6, 2024K240796myAblation Guide (VB80A)
Siemens Healthcare GmbH, DE
QTZ
May 23, 2024K240294Syngo Carbon Enterprise Access (VA40A)
Siemens Healthcare GmbH, DE
LLZ
Mar 21, 2024K233753AI-Rad Companion (Pulmonary)
Siemens Healthcare GmbH, DE
JAK
Dec 21, 2023K232744syngo Virtual Cockpit (VB10A)
Siemens Healthcare GmbH, DE
LLZ
Dec 1, 2023K232856Syngo Carbon Clinicals
Siemens Healthcare GmbH, DE
QIH
Jul 19, 2023K231157syngo.CT Lung CAD (Version VD30)
Siemens Healthcare GmbH, DE
OEB
Mar 21, 2023K230561Syngo Carbon Space VA30A
Siemens Healthcare GmbH, DE
LLZ
Feb 13, 2023K230196syngo.via View&GO VA40A
Siemens Healthcare GmbH, DE
LLZ
Oct 14, 2022K221501syngo.via View&GO
Siemens Healthcare GmbH, DE
LLZ
Aug 11, 2022K213713AI-Rad Companion (Pulmonary)
Siemens Healthcare GmbH
JAK
Jun 21, 2022K213665Syngo Carbon Space VA20A
Siemens Healthcare GmbH, DE
LLZ
Apr 15, 2022K213706AI-Rad Companion Brain MR
Siemens Healthcare GmbH
QIH
Mar 31, 2021K203258syngo.CT Lung CAD
Siemens Healthcare GmbH, DE
OEB
Jul 1, 2020K201477syngo.via View&GO
Siemens Healthcare GmbH, DE
LLZ
May 16, 2019K191040syngo.via (Version VB40A)
Siemens Healthcare GmbH, DE
LLZ
Sep 7, 2018K182208syngo.via View&GO (Version VA10A)
Siemens Healthcare GmbH, DE
LLZ
Apr 25, 2018K180563syngo.plaza
Siemens Healthcare GmbH, DE
LLZ
Nov 20, 2017K173378syngo®.via protoNeo (Version VA20)
Siemens Healthcare GmbH, DE
LLZ
Aug 16, 2017K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems
Siemens Healthcare
IYN
Jun 1, 2017K171053syngo Dynamics Version VA30
Siemens Healthcare GmbH, DE
LLZ
Apr 21, 2017K170221syngo.CT Cardiac Planning
Siemens Healthcare GmbH, DE
JAK
Jul 11, 2016K161685syngo®.via protoNeo (Version VA10A)
Siemens Healthcare GmbH, DE
LLZ
Dec 9, 2013K132532SYNGO.PLAZA VB10A
Siemens AG Healthcare, DE
LLZ

Latest recalls

DateFirm and productCodeLinked 510(k)
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