FDA-cleared K170747

syngo Application Software

Siemens Medical Solutions, USA, Inc.

syngo Application Software is a medical software for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange...

Modality
Ultrasound
Anatomy
N/A
Decision
2017-06-09
FDA-cleared K183271

AI-Rad Companion (Pulmonary)

Siemens Medical Solutions USA, Inc.

Image analysis/processing for Chest/Lung using CT/CTA.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2019-07-26
FDA-cleared K192763

syngo.CT CaScoring

Siemens Medical Solutions USA, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2019-12-17
FDA-cleared K201034

Syngo.CT CaScoring

Siemens Medical Solutions USA, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2020-05-14
FDA-cleared K193290

AI-Rad Companion Brain MR

Siemens Medical Solutions USA, Inc.

Image analysis/processing for Brain using MRI.

Modality
MRI
Anatomy
Brain
Decision
2020-06-17
FDA-cleared K210611

MAGNETOM Free.Max

Siemens Medical Solutions USA, Inc.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2021-07-01
FDA-cleared K213096

Al-Rad Companion (Pulmonary)

Siemens Medical Solutions USA, Inc.

Image analysis/processing for Chest/Lung using CT/CTA.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2021-12-06
FDA-cleared K220151

MAGNETOM Avanto Fit

Siemens Medical Solutions USA, Inc.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2022-04-01
FDA-cleared K220589

MAGNETOM Skyra Fit

Siemens Medical Solutions USA, Inc.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2022-05-13
FDA-cleared K221219

syngo.CT CaScoring

Siemens Medical Solutions USA, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-05-17
FDA-cleared K222172

MI View&GO

Siemens Medical Solutions USA, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-08-19
FDA-cleared K231587

MAGNETOM Cima.X

Siemens Medical Solutions USA, Inc.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2023-12-18
FDA-cleared K233677

Biograph VK10

Siemens Medical Solutions USA, Inc.

Image analysis/processing.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2024-01-12
FDA-cleared K232765

MAGNETOM Cima.X Fit

Siemens Medical Solutions USA, Inc.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2024-02-29
FDA-cleared K233657

NAEOTOM Alpha

Siemens Medical Solutions USA, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-03-28
FDA-cleared K242300

MI View&GO

Siemens Medical Solutions USA, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-08-30
FDA-cleared K243145

syngo.CT LVO Detection

Siemens Medical Solutions USA, Inc.

Image analysis/processing for Brain using CT/CTA.

Modality
CT/CTA
Anatomy
Brain
Decision
2025-04-10