Radiology AI Directory

Vendor

Siemens Medical Solutions USA, Inc.

67 FDA-cleared listings in this directory.

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FDA-cleared K253786

syngo.CT Coronary Cockpit

Siemens Medical Solutions USA, Inc.

An extension for syngo.via that assists trained physicians with automated and semi-automated analysis, visualization and reporting of cardiac CT angiography volume datasets for...

Modality
CT/CTA
Anatomy
Heart/Cardiovascular
Decision
2026-06-25
Cardiac imaging
FDA-cleared K260844

ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System

Siemens Medical Solutions USA, Inc.

ACUSON Sequoia, Select, Origin, and Origin ICE diagnostic ultrasound systems acquire and display the labeled fetal, abdominal, pediatric, neonatal, cephalic, small-part,...

Modality
Ultrasound
Anatomy
Fetus; abdomen; pelvis; small organs; head; heart; peripheral vessels; musculoskeletal anatomy; transesophageal and intracardiac applications
Decision
2026-06-16
Cardiac imagingUltrasound workflow
FDA-cleared K253574

SOMATOM X.cite; SOMATOM X.ceed

Siemens Medical Solutions USA, Inc.

SOMATOM X.cite and X.ceed with syngo CT VB20 support diagnostic CT, interventions, treatment preparation, radiation-therapy planning, and qualified low-dose lung screening.

Modality
CT/CTA
Anatomy
Multi-region
Decision
2026-03-20
CT/CTA workflow
FDA-cleared K254016

MI View&GO

Siemens Medical Solutions USA, Inc.

MI View&GO is a medical diagnostic application for viewing, manipulating, quantifying, analyzing, and comparing PET, nuclear-medicine, CT, and MR images across one or more time...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Whole body, organs, tumors, heart, brain, and oncology regions
Decision
2026-02-10
Radiotherapy planningCardiac imagingOncology quantification
FDA-cleared K251481

ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System

Siemens Medical Solutions USA, Inc.

ACUSON Sequoia, Select, Origin, and Origin ICE are multipurpose diagnostic ultrasound systems for the labeled fetal, abdominal, pediatric, cephalic, cardiac, vascular,...

Modality
Ultrasound
Anatomy
Fetus; abdomen; pelvis; small organs; head; heart; peripheral vessels; musculoskeletal anatomy; and urologic organs
Decision
2025-08-20
Cardiac imagingUltrasound workflow
FDA-cleared K243145

syngo.CT LVO Detection

Siemens Medical Solutions USA, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
Brain
Decision
2025-04-10
Detection and CADeAcute triage and notification
FDA-cleared K242523

ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System

Siemens Medical Solutions USA, Inc.

The ACUSON Sequoia and Sequoia Select systems provide images or signals from inside the body for fetal, abdominal, pediatric, neonatal cephalic, small-parts, OB/GYN, cardiac,...

Modality
Ultrasound
Anatomy
Fetal, abdominal, pelvic, cardiac, hepatic, vascular, cephalic, small-organ, musculoskeletal, and peripheral vascular anatomy
Decision
2024-11-19
Cardiac imagingUltrasound workflow
FDA-approved P140011/S008

MAMMOMAT B.brilliant with Tomosynthesis Option

SIEMENS MEDICAL SOLUTIONS USA, INC.

The FDA PMA supplement record identifies MAMMOMAT B.brilliant with Tomosynthesis Option as digital breast tomosynthesis and approves a new PREMIA reconstruction algorithm, updated...

Modality
Mammography/DBT
Anatomy
Breast
Decision
2024-09-23
Breast imaging
FDA-cleared K242300

MI View&GO

Siemens Medical Solutions USA, Inc.

MI View&GO is a medical diagnostic application for viewing, manipulating, quantifying, analyzing, and comparing PET, nuclear-medicine, CT, and MR images. The FDA material...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Multi-region PET, nuclear-medicine, CT, and MR studies
Decision
2024-08-30
Radiotherapy planningOncology quantificationQuantification and segmentation
FDA-cleared K240704

ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System

Siemens Medical Solutions, USA, Inc.

The ACUSON systems are intended to provide images or signals from inside the body by appropriately trained healthcare professionals in clinical settings for fetal, abdominal,...

Modality
Ultrasound
Anatomy
Fetal/obstetric, abdominal, pelvic, cardiac, vascular, cephalic, small-organ, musculoskeletal, and urologic anatomy
Decision
2024-07-22
Cardiac imagingUltrasound workflow
FDA-cleared K232799

syngo.via RT Image Suite

Siemens Medical Solutions USA, Inc.

syngo.via RT Image Suite VB80 supports trained radiation-oncology professionals with multimodality visualization, registration, advanced contouring, treatment preparation,...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2024-04-26
Radiotherapy planningOncology quantification
FDA-cleared K233657

NAEOTOM Alpha

Siemens Medical Solutions USA, Inc.

NAEOTOM Alpha with syngo CT VB10 provides photon-counting CT for diagnosis, treatment and interventional support, and approved low-dose lung screening; this submission explicitly...

Modality
CT/CTA
Anatomy
Multi-region
Decision
2024-03-28
CT/CTA workflow
FDA-cleared K232322

MAGNETOM Terra; MAGNETOM Terra.X

Siemens Medical Solutions USA, Inc.

MAGNETOM Terra and Terra.X with syngo MR XA60A provide 7T proton MRI of the head and extremities, sodium head imaging, and phosphorus spectroscopy of the body excluding the head...

Modality
MRI
Anatomy
Head/Extremities
Decision
2024-03-22
MRI workflow
FDA-cleared K232431

syngo.CT Brain Hemorrhage

Siemens Medical Solutions USA, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
Brain
Decision
2024-03-22
Detection and CADeAcute triage and notification
FDA-cleared K232765

MAGNETOM Cima.X Fit

Siemens Medical Solutions USA, Inc.

MAGNETOM Cima.X Fit is a magnetic-resonance diagnostic device that produces transverse, sagittal, coronal, and oblique images, spectroscopic images and spectra, and physical...

Modality
MRI
Anatomy
Head, body, and extremities
Decision
2024-02-29
MRI workflow
FDA-cleared K233677

Biograph VK10

Siemens Medical Solutions USA, Inc.

The Biograph VK10 combines X-ray CT and PET to register and fuse anatomic and physiologic information, supports independent CT or PET imaging, and aids trained professionals in...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Whole body, cardiovascular, neurological, oncologic, and organ-function imaging
Decision
2024-01-12
Radiotherapy planningOncology quantificationDetection and CADe
FDA-cleared K232535

MAGNETOM Sola; MAGNETOM Altea

Siemens Medical Solutions USA, Inc.

MAGNETOM Sola and Altea with syngo MR XA61A provide standard head, body, extremity, and interventional MRI and add release-specific Deep Resolve, OpenRecon, implant-suite, and...

Modality
MRI
Anatomy
Multi-region
Decision
2023-12-22
MRI workflow
FDA-cleared K231587

MAGNETOM Cima.X

Siemens Medical Solutions USA, Inc.

MAGNETOM Cima.X produces cross-sectional and spectroscopic MR images of the head, body, and extremities for qualified professional interpretation; exact field strength, coils,...

Modality
MRI
Anatomy
Multi-region
Decision
2023-12-18
MRI workflow
FDA-cleared K232494

MAGNETOM Avanto fit; MAGNETOM Skyra fit

Siemens Medical Solutions USA, Inc.

MAGNETOM Avanto fit and Skyra fit with syngo MR XA61A provide broad diagnostic and interventional MRI and add coils, phase-contrast gradient echo, physiological logging, and an...

Modality
MRI
Anatomy
Multi-region
Decision
2023-11-14
MRI workflow
FDA-cleared K231617

MAGNETOM Free.Max; MAGNETOM Free.Star

Siemens Medical Solutions USA, Inc.

MAGNETOM Free.Max and Free.Star are 0.55T MRI systems for broad head, body, extremity, and release-specific diagnostic imaging workflows.

Modality
MRI
Anatomy
Multi-region
Decision
2023-11-09
MRI workflow
FDA-cleared K232145

ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System

Siemens Medical Solutions USA, Inc.

The ACUSON Sequoia and Sequoia Select systems provide ultrasound images or signals for the labeled fetal, abdominal, pediatric, neonatal cephalic, small-parts, OB/GYN, cardiac,...

Modality
Ultrasound
Anatomy
Fetal, abdominal, pediatric, neonatal cephalic, small parts, OB/GYN, cardiac, pelvic, vascular, adult cephalic, musculoskeletal, peripheral vascular, intracardiac, and intraluminal cardiac or great-vessel anatomy
Decision
2023-10-30
Cardiac imagingOncology quantificationQuantification and segmentation
FDA-cleared K232482

MAGNETOM Viato.Mobile

Siemens Medical Solutions USA, Inc.

The MAGNETOM Viato.Mobile is an MR diagnostic device that produces transverse, sagittal, coronal, and oblique cross-sectional images, spectroscopic images or spectra, and other...

Modality
MRI
Anatomy
Head, body, and extremities
Decision
2023-09-06
MRI workflow
FDA-cleared K231833

Biograph Vision.X and Biograph Vision.X Edge

Siemens Medical Solutions USA, Inc.

The Biograph Vision.X and Biograph Vision.X Edge combine X-ray CT and PET to register and fuse anatomic and physiologic information, support independent CT or PET imaging, aid...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Whole body, cardiovascular, neurological, oncologic, and organ-function imaging
Decision
2023-07-13
Radiotherapy planningOncology quantificationDetection and CADe
FDA-cleared K223343

MAGNETOM Amira; MAGNETOM Sempra

Siemens Medical Solutions USA Inc.

MAGNETOM Amira and MAGNETOM Sempra produce diagnostic MR images in the labeled scanner, coil, sequence, anatomy, and professional-interpretation workflow.

Modality
MRI
Anatomy
Multi-region
Decision
2023-03-28
MRI workflow
FDA-cleared K222428

Syngo Dynamics (Version VA40F)

Siemens Medical Solutions USA, Inc.

Syngo Dynamics VA40F is a multimodality, vendor-agnostic cardiology image and information system for medical-image management and processing, with post-processing functions for...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Anatomy represented in multimodality cardiology medical images, excluding U.S. digital mammography diagnosis
Decision
2022-11-14
Breast imagingDetection and CADeQuantification and segmentation
FDA-cleared K222361

AI-Rad Companion (Musculoskeletal)

Siemens Medical Solutions USA, Inc.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Bone
Decision
2022-10-20
MSK and bone
FDA-cleared K221305

AI-Rad Companion Organs RT

Siemens Medical Solutions USA, Inc

AI-Rad Companion Organs RT VA40 automatically contours predefined structures from adult DICOM CT for qualified review and DICOM RTSTRUCT transfer; this release added 29...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2022-10-14
Radiotherapy planningDetection and CADe
FDA-cleared K221733

MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit

Siemens Medical Solutions USA, Inc.

MAGNETOM Sola, MAGNETOM Altea, and MAGNETOM Sola Fit with syngo MR XA51A produce cross-sectional and spectroscopic MR images and physical parameters of the head, body, and...

Modality
MRI
Anatomy
Head, body, and extremities
Decision
2022-09-13
MRI workflow
FDA-cleared K220783

syngo.via RT Image Suite

Siemens Medical Solutions USA Inc.

syngo.via RT Image Suite VB70 supports multimodality radiation-therapy image review, registration, contouring, treatment preparation, DICOM export, and lobe-based lung ventilation...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2022-09-07
Radiotherapy planning
FDA-cleared K222172

MI View&GO

Siemens Medical Solutions USA, Inc.

MI View&GO is a multimodality medical-image application for viewing, manipulating, quantifying, analyzing, and comparing PET, SPECT, CT, and MR images across time points in...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Whole body, organs, tumors, heart, brain, and oncology regions
Decision
2022-08-19
Radiotherapy planningCardiac imagingOncology quantification
FDA-cleared K221727

syngo.CT Extended Functionality

Siemens Medical Solutions USA, Inc.

syngo.CT Extended Functionality provides advanced visualization and processing tools for CT-acquired or reconstructed data, including labeled vessel, spectral, pulmonary,...

Modality
CT/CTA
Anatomy
Vessels, lungs, nodules, oncology, trauma, and other anatomy represented in CT studies
Decision
2022-07-13
Oncology quantificationQuantification and segmentation
FDA-cleared K220575

MAGNETOM Free.Max, MAGNETOM Free.Star

Siemens Medical Solutions USA, Inc.

MAGNETOM Free.Max and MAGNETOM Free.Star produce diagnostic MR images in the labeled scanner, coil, sequence, anatomy, and professional-interpretation workflow.

Modality
MRI
Anatomy
Multi-region
Decision
2022-06-24
MRI workflow
FDA-cleared K221219

syngo.CT CaScoring

Siemens Medical Solutions USA, Inc.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-05-17
CT/CTA workflow
FDA-cleared K220589

MAGNETOM Skyra Fit

Siemens Medical Solutions USA, Inc.

MAGNETOM Skyra Fit with syngo MR XA50A is a 3T system for broad head, body, and extremity MRI; this release includes TSE motion correction and automatic breast-biopsy fiducial...

Modality
MRI
Anatomy
Multi-region
Decision
2022-05-13
Breast imagingDetection and CADe
FDA-cleared K220939

MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A

Siemens Medical Solutions USA Inc.

MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A produce diagnostic MR images in the labeled scanner and protocol workflow for professional interpretation.

Modality
MRI
Anatomy
Multi-region
Decision
2022-04-29
MRI workflow
FDA-cleared K220151

MAGNETOM Avanto Fit

Siemens Medical Solutions USA, Inc.

MAGNETOM Avanto Fit is a diagnostic MR system that produces transverse, sagittal, coronal, and oblique images, spectroscopic images and spectra, and physical parameters of the...

Modality
MRI
Anatomy
Head, body, and extremities
Decision
2022-04-01
MRI workflow
FDA-cleared K213693

MAGNETOM Vida with syngo MR XA50A

Siemens Medical Solutions USA, Inc.

MAGNETOM Vida with syngo MR XA50A is a diagnostic MR system that produces cross-sectional and spectroscopic images and physical parameters of the head, body, and extremities for...

Modality
MRI
Anatomy
Head, body, and extremities
Decision
2022-02-25
MRI workflow
FDA-cleared K203260

syngo.CT Brain Hemorrhage

Siemens Medical Solutions USA, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
Brain
Decision
2022-01-28
Detection and CADeAcute triage and notification
FDA-cleared K214019

syngo.CT Extended Functionality

Siemens Medical Solutions USA, Inc.

syngo.CT Extended Functionality provides advanced visualization and processing of CT-acquired or reconstructed data, with labeled trauma, spectral, vascular, pulmonary, oncology,...

Modality
CT/CTA
Anatomy
Trauma, vessels, lungs, oncology, and other anatomy represented in CT or MR studies
Decision
2022-01-20
Oncology quantificationQuantification and segmentation
FDA-cleared K213096

Al-Rad Companion (Pulmonary)

Siemens Medical Solutions USA, Inc.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2021-12-06
Chest CT
FDA-cleared K211379

syngo.via RT Image Suite

Siemens Medical Solutions USA Inc.

syngo.via RT Image Suite VB60 supports trained radiation-oncology professionals with multimodality visualization, registration, contouring, treatment preparation, DICOM export,...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2021-07-30
Radiotherapy planningOncology quantification
FDA-cleared K210611

MAGNETOM Free.Max

Siemens Medical Solutions USA, Inc.

MAGNETOM Free.Max with syngo MR XA40A is a 0.55T, 80-cm-bore system for broad head, body, and extremity diagnostic MRI.

Modality
MRI
Anatomy
Multi-region
Decision
2021-07-01
MRI workflow
FDA-cleared K211459

syngo.via MI WorkFlows, Scenium, syngo MBF

Siemens Medical Solutions USA, Inc.

syngo.via MI WorkFlows, Scenium, and syngo MBF support the viewing, processing, and quantitative review of supported molecular-imaging and cardiac studies in the exact K211459...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Cardiac, whole-body, and other anatomy represented in supported PET/CT, SPECT, or MR studies
Decision
2021-06-10
Cardiac imagingQuantification and segmentation
FDA-cleared K203443

MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea

Siemens Medical Solutions USA, Inc.

MAGNETOM Vida, Sola, Lumina, and Altea acquire cross-sectional images, spectra, and derived physical parameters of the head, body, and extremities for trained physician...

Modality
MRI
Anatomy
Multi-region
Decision
2021-03-31
MRI workflow
FDA-cleared K201195

syngo.via MI Workflows, syngo MBF

Siemens Medical Solutions USA, Inc.

syngo.via molecular-imaging workflows provide viewing, manipulation, quantification, analysis, and comparison of medical images from one or more modalities and time points,...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Whole-body, cardiac, neurologic, oncologic, organ-function, and radiotherapy-planning anatomy represented in PET, nuclear-medicine, CT, and MR studies
Decision
2020-11-18
Radiotherapy planningCardiac imagingOncology quantification
FDA-cleared K193562

AI-Rad Companion Organs RT

Siemens Medical Solutions USA, Inc.

AI-Rad Companion Organs RT VA20 automatically contours predefined organs at risk from adult DICOM CT for qualified review, editing, and DICOM RTSTRUCT transfer into...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2020-11-06
Radiotherapy planningDetection and CADe
FDA-cleared K201444

Syngo.via RT Image Suite

Siemens Medical Solutions USA, Inc.

syngo.via RT Image Suite VB50 supports trained radiation-oncology professionals with multimodality visualization, registration, contouring, simple treatment preparation, and DICOM...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2020-08-13
Radiotherapy planningOncology quantification
FDA-cleared K193283

AI-Rad Companion Prostate MR

Siemens Medical Solutions USA Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
MRI
Anatomy
Prostate
Decision
2020-07-30
Prostate imaging
FDA-cleared K193294

AI-Rad Companion Engine

Siemens Medical Solutions USA, Inc.

AI-Rad Companion Engine is a software platform that provides basic visualization and enables external post-processing extensions for medical images used for diagnostic purposes....

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Medical images and clinical data represented in multimodality DICOM studies
Decision
2020-07-10
Quantification and segmentation
FDA-cleared K193290

AI-Rad Companion Brain MR

Siemens Medical Solutions USA, Inc.

AI-Rad Companion Brain MR post-processes typical head-MR T1 MPRAGE images to automatically segment and quantify brain structures, compare normalized volumes with healthy reference...

Modality
MRI
Anatomy
Brain
Decision
2020-06-17
Quantification and segmentationNeuro MRI
FDA-cleared K201034

Syngo.CT CaScoring

Siemens Medical Solutions USA, Inc.

syngo.CT CaScoring analyzes noncontrast standard- or low-dose cardiac CT, marks calcified coronary lesions, allocates them to the right coronary, left main, left anterior...

Modality
CT/CTA
Anatomy
Heart and coronary arteries
Decision
2020-05-14
Cardiac imaging
FDA-cleared K193267

Al-Rad Companion (Musculoskeletal)

Siemens Medical Solutions USA, Inc.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Bone
Decision
2020-03-16
MSK and bone
FDA-cleared K192763

syngo.CT CaScoring

Siemens Medical Solutions USA, Inc.

syngo.CT CaScoring analyzes noncontrast cardiac CT, marks and allocates calcified coronary lesions to the right coronary, left main, left anterior descending, or circumflex...

Modality
CT/CTA
Anatomy
Heart and coronary arteries
Decision
2019-12-17
Cardiac imaging
FDA-cleared K192065

Syngo.Via RT Image Suite

Siemens Medical Solutions USA, Inc.

syngo.via RT Image Suite VB40 supports trained radiation-oncology professionals with multimodality visualization, registration, contouring, simple treatment preparation, DICOM...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2019-09-18
Radiotherapy planningOncology quantification
FDA-cleared K183268

AI-Rad Companion (Cardiovascular)

Siemens Medical Solutions USA, Inc.

AI-Rad Companion Cardiovascular processes previously acquired CT DICOM studies to support quantitative and qualitative cardiovascular analysis, including heart segmentation and...

Modality
CT/CTA
Anatomy
Heart, coronary arteries, aorta, and adult thorax
Decision
2019-09-10
Cardiac imagingQuantification and segmentation
FDA-cleared K183271

AI-Rad Companion (Pulmonary)

Siemens Medical Solutions USA, Inc.

AI-Rad Companion Pulmonary processes CT DICOM studies to support lung and lobe segmentation, measurements, density thresholds, and pulmonary-lesion segmentation, measurement, and...

Modality
CT/CTA
Anatomy
Lungs, lobes, pulmonary lesions, and adult thorax
Decision
2019-07-26
Quantification and segmentation
FDA-cleared K170747

syngo Application Software

Siemens Medical Solutions, USA, Inc.

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

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Anatomy represented in supported medical images and interventional procedures
Decision
2017-06-09
Oncology quantification
FDA-cleared K133259

YSIO MAX

SIEMENS MEDICAL SOLUTIONS USA, INC.

YSIO MAX is a digital radiography system for whole-body skull, chest, abdomen, and extremity imaging in pediatric, adult, and bariatric patients, including supported emergency and...

Modality
X-ray/Radiography
Anatomy
Multi-region
Decision
2014-01-24
Breast imaging