Siemens Healthcare GmbH
Berlin, DE
Siemens Healthcare GmbH appears in FDA device records in Berlin, DE. FDA records list 32 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 32 510(k) clearances for Siemens Healthcare GmbH between 2016 and 2026. The busiest year on record is 2025, with 6. The most recent is 2026, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2017 | 4 |
| 2018 | 2 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 4 |
| 2023 | 5 |
| 2024 | 3 |
| 2025 | 6 |
| 2026 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253264 | myAblation Guide (VC10A) | QTZ | Substantially Equivalent | |
| K253689 | syngo Dynamics (VA41F) | QIH | Substantially Equivalent | |
| K252548 | AI-Rad Companion Organs RT | QKB | Substantially Equivalent | |
| K253057 | AI-Rad Companion Brain MR | QIH | Substantially Equivalent | |
| K252838 | MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise | LNH | Substantially Equivalent | |
| K252608 | AI-Rad Companion Prostate MR | LLZ | Substantially Equivalent | |
| K250443 | MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile | LNH | Substantially Equivalent | |
| K242551 | syngo Dynamics (Version VA41D) | QIH | Substantially Equivalent | |
| K242745 | AI-Rad Companion Organs RT | QKB | Substantially Equivalent | |
| K241770 | Prostate MR AI (VA10A) | QDQ | Substantially Equivalent | |
| K240796 | myAblation Guide (VB80A) | QTZ | Substantially Equivalent | |
| K240294 | Syngo Carbon Enterprise Access (VA40A) | LLZ | Substantially Equivalent | |
| K233753 | AI-Rad Companion (Pulmonary) | JAK | Substantially Equivalent | |
| K232744 | syngo Virtual Cockpit (VB10A) | LLZ | Substantially Equivalent | |
| K232856 | Syngo Carbon Clinicals | QIH | Substantially Equivalent | |
| K231157 | syngo.CT Lung CAD (Version VD30) | OEB | Substantially Equivalent | |
| K230561 | Syngo Carbon Space VA30A | LLZ | Substantially Equivalent | |
| K230196 | syngo.via View&GO VA40A | LLZ | Substantially Equivalent | |
| K221501 | syngo.via View&GO | LLZ | Substantially Equivalent | |
| K213713 | AI-Rad Companion (Pulmonary) | JAK | Substantially Equivalent | |
| K213665 | Syngo Carbon Space VA20A | LLZ | Substantially Equivalent | |
| K213706 | AI-Rad Companion Brain MR | QIH | Substantially Equivalent | |
| K203258 | syngo.CT Lung CAD | OEB | Substantially Equivalent | |
| K201477 | syngo.via View&GO | LLZ | Substantially Equivalent | |
| K191040 | syngo.via (Version VB40A) | LLZ | Substantially Equivalent | |
| K182208 | syngo.via View&GO (Version VA10A) | LLZ | Substantially Equivalent | |
| K180563 | syngo.plaza | LLZ | Substantially Equivalent | |
| K173378 | syngo®.via protoNeo (Version VA20) | LLZ | Substantially Equivalent | |
| K172162 | ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems | IYN | Substantially Equivalent | |
| K171053 | syngo Dynamics Version VA30 | LLZ | Substantially Equivalent | |
| K170221 | syngo.CT Cardiac Planning | JAK | Substantially Equivalent | |
| K161685 | syngo®.via protoNeo (Version VA10A) | LLZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011194542 | 3011194542 | Siemens Healthcare GmbH | Am Studio 1, Berlin 12489 DE | 2026 | |
| 3012127758 | 3012127758 | Siemens Healthcare Limited | 1577 North Service Road East, Oakville Ontario L6H 0H6 CA | 2026 | and 8 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- ITYAssembly, Tube Housing, X-Ray, Diagnostic
- QIHAutomated Radiological Image Processing Software
- JQPCalculator/Data Processing Module, For Clinical Use
- OBJCatheter, Ultrasound, Intravascular
- OTEDigital Breast Tomosynthesis
- MUEFull Field Digital, System, X-Ray, Mammographic
- OXOImage-Intensified Fluoroscopic X-Ray System, Mobile
- DXTInjector And Syringe, Angiographic
- OWBInterventional Fluoroscopic X-Ray System
- OEBLung Computed Tomography System, Computer-Aided Detection
- QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
- QTZRadiological Image Processing Software For Ablation Therapy Planning And Evaluation
- QKBRadiological Image Processing Software For Radiation Therapy
- MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
- LLZSystem, Image Processing, Radiological
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- LNHSystem, Nuclear Magnetic Resonance Imaging
- LNISystem, Nuclear Magnetic Resonance Spectroscopic
- IZISystem, X-Ray, Angiographic
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- IZLSystem, X-Ray, Mobile
- KPRSystem, X-Ray, Stationary
- JAKSystem, X-Ray, Tomography, Computed
- ITXTransducer, Ultrasonic, Diagnostic
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain