FDA-cleared K203258
syngo.CT Lung CAD
Siemens Healthcare GmbH
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2021-03-31
Vendor
Siemens Healthcare GmbH
12 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K213706
AI-Rad Companion Brain MR
Siemens Healthcare GmBh
Image analysis/processing for Brain using MRI.
- Modality
- MRI
- Anatomy
- Brain
- Decision
- 2022-04-15
FDA-cleared K213713
AI-Rad Companion (Pulmonary)
Siemens Healthcare GmBh
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2022-08-11
FDA-cleared K231157
syngo.CT Lung CAD (Version VD30)
Siemens Healthcare GmbH
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2023-07-19
FDA-cleared K232856
Syngo Carbon Clinicals
Siemens Healthcare GmbH
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2023-12-01
FDA-cleared K233753
AI-Rad Companion (Pulmonary)
Siemens Healthcare GmbH
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2024-03-21
FDA-cleared K240294
Syngo Carbon Enterprise Access (VA40A)
Siemens Healthcare GmbH
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2024-05-23
FDA-cleared K241770
Prostate MR AI (VA10A)
Siemens Healthcare GmbH
Image analysis/processing for Prostate using Mammography/DBT.
- Modality
- Mammography/DBT
- Anatomy
- Prostate
- Decision
- 2025-03-05
FDA-cleared K242745
AI-Rad Companion Organs RT
Siemens Healthcare GmbH
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2025-03-27
FDA-cleared K242551
syngo Dynamics (Version VA41D)
Siemens Healthcare GmbH
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2025-04-03
FDA-cleared K250443
MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile
Siemens Healthcare GmbH
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-06-16
FDA-cleared 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
Siemens Healthcare GmbH
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-12-19