FDA-cleared K253560

Enhanced Boundary for PCCT

Ge Medical Systems, LLC

Enhanced Boundary for PCCT is a deep-learning CT processing function for improved soft-tissue delineation in routine head examinations with or without contrast.

Modality
CT/CTA
Anatomy
Head
Decision
2026-06-24
FDA-cleared K253649

Spectral CT Verida Family

Philips Medical Systems Technologies, Ltd.

Spectral CT Verida Family supports the labeled spectral CT acquisition, reconstruction, material-map, and professional-interpretation workflow; exact models, protocols, and...

Modality
CT/CTA
Anatomy
Multi-region
Decision
2026-03-27
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
FDA-cleared K252041

Fibresolve (with PCCP)

Imvaria, Inc.

Fibresolve analyzes lung CT in patients with pulmonary symptoms to provide an adjunct diagnostic-subtype classification for suspected interstitial lung disease and support...

Modality
CT/CTA
Anatomy
Lungs and interstitial lung disease patterns
Decision
2025-11-07
FDA-cleared K250290

SurgiTwin

Twinsight

SurgiTwin is a web pre-surgical knee-planning system that uses patient CT images to provide two-dimensional and three-dimensional planning information and a PDF report for adults...

Modality
CT/CTA
Anatomy
Knee
Decision
2025-08-29
FDA-cleared K250221

StrokeSENS ASPECTS Software Application

Circle Cardiovascular Imaging Inc.

ASPECTS scoring and highlighted-region/voxel visualization to assist assessment of ischemic brain injury in known MCA/ICA occlusion within 12 hours from last known well.

Modality
CT/CTA
Anatomy
Brain ASPECTS regions in patients with known MCA or ICA occlusion
Decision
2025-07-01
FDA-cleared K250370

SCENARIA View Phase 5.0

FUJIFILM Corporation

SCENARIA View acquires axial, helical, dynamic, and interventional CT images of the body, including the head and whole body, supports reformats and volume rendering, and includes...

Modality
CT/CTA
Anatomy
Whole body, head, thorax, and lungs
Decision
2025-05-20
FDA-cleared K242123

Brainomix 360 e-CTA

Brainomix Limited

Brainomix 360 e-CTA analyzes adult CTA brain DICOM for vessel visualization and post-processing, including MCA vessel-density asymmetry, contrast/phase context, overlays, and MIP...

Modality
CT/CTA
Anatomy
Brain
Decision
2025-01-06
FDA-cleared K232491

CT 5300

Philips Healthcare (Suzhou) Co., Ltd.

CT 5300 acquires head and whole-body cross-sectional CT images for diagnosis in adult and pediatric patients and supports low-dose lung-cancer screening under approved protocols.

Modality
CT/CTA
Anatomy
Multi-region
Decision
2024-05-03
FDA-cleared K240291

EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM

Ever Fortune.AI, Co., Ltd.

Assist hospital networks and appropriately trained medical specialists in triaging adults aged 22 years and older by flagging suspected aortic dissection or aortic intramural...

Modality
CT/CTA
Anatomy
Chest, abdomen, and thoracoabdominal aorta
Decision
2024-04-08
FDA-cleared K240172

Preview Shoulder

Genesis Software Innovations

Preoperative shoulder-arthroplasty planning from adult CT DICOM images, including three-dimensional anatomy and implant-placement planning; it does not diagnose or recommend a...

Modality
CT/CTA
Anatomy
Shoulder
Decision
2024-04-04
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
FDA-cleared K230534

BriefCase-Quantification

Aidoc Medical, Ltd.

Assist appropriately trained medical specialists by providing the maximum abdominal aortic axial diameter from contrast-enhanced CT exams that include the abdominal aorta in...

Modality
CT/CTA
Anatomy
Abdominal aorta
Decision
2023-11-08
FDA-cleared K213986

CerebralGo Plus

Yukun (Beijing) Technology Co., Ltd

Viewing and processing of adult CTA datasets by trained professionals; not for primary diagnostic use.

Modality
CT/CTA
Anatomy
Head and neck large vessels
Decision
2023-04-13
FDA-cleared K213272

Formus Hip

Formus Labs, Ltd

CT-based preoperative planning for hip surgery, including interactive implant-geometry overlay and generation of a surgeon-reviewable planning report.

Modality
CT/CTA
Anatomy
Hip
Decision
2023-03-31
FDA-cleared K221564

Brainomix 360 e-ASPECTS

Brainomix Limited

Assists clinician assessment of brain abnormalities and ischemic injury by generating an automated ASPECTS score for known MCA/ICA occlusion cases.

Modality
CT/CTA
Anatomy
Brain
Decision
2023-02-23
FDA-cleared K211443

AIBOLIT 3D+

AIbolit Technologies, LLC

AIBOLIT 3D+ processes, reviews, analyzes, communicates, and interchanges multidimensional digital images acquired from CT to support preoperative surgical planning, training,...

Modality
CT/CTA
Anatomy
Patient-specific anatomy represented in CT images for preoperative and intraoperative planning
Decision
2022-01-07
FDA-cleared K203448

uCT ATLAS with uWS-CT-Dual Energy Analysis

Shanghai United Imaging Healthcare Co., Ltd.

uCT ATLAS with uWS-CT-Dual Energy Analysis supports the labeled CT acquisition, reconstruction, and dual-energy image-analysis workflow for professional interpretation.

Modality
CT/CTA
Anatomy
Multi-region
Decision
2021-08-11
FDA-cleared K212074

ClariCT.AI

ClariPi Inc.

ClariCT.AI receives, processes, and enhances supported CT DICOM images regardless of the labeled CT manufacturer or model for professional review within the cleared workflow.

Modality
CT/CTA
Anatomy
Multi-region
Decision
2021-07-27
FDA-cleared K203514

Precise Position

Philips Healthcare (Suzhou) Co., Ltd.

Precise Position uses a ceiling-mounted color and depth camera with a convolutional neural network to assist positioning patients aged 16 years and older on Philips Incisive CT by...

Modality
CT/CTA
Anatomy
Multi-region
Decision
2021-06-17
FDA-cleared K210556

Preview Shoulder

Genesis Software Innovations

Tool for orthopedic surgeons to develop pre-operative shoulder arthroplasty plans from patient CT imaging.

Modality
CT/CTA
Anatomy
Shoulder
Decision
2021-04-21
FDA-cleared K203617

MaxFOV 2

GE Medical Systems, LLC.

MaxFOV 2 is a deep-learning CT image reconstruction method for head and whole-body axial, helical, and cine acquisitions. It extends the nominal display field of view when patient...

Modality
CT/CTA
Anatomy
Head and whole body; anatomy outside the nominal display field of view
Decision
2021-03-02
FDA-cleared K203042

Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I

Canon Medical Systems Corporation

The device is indicated to acquire and display cross-sectional volumes of the whole body, including the head. Volume sets may be used for specialized studies by a trained and...

Modality
CT/CTA
Anatomy
Whole body including head; abdomen, pelvis, lung, extremity, head, and inner-ear applications
Decision
2020-12-10
FDA-cleared K203169

Revolution Ascend

GE Healthcare Japan Corporation

Revolution Ascend is a diagnostic CT system for acquisition, reconstruction, display, and professional interpretation in the labeled scanner and protocol workflow.

Modality
CT/CTA
Anatomy
Multi-region
Decision
2020-11-20
FDA-cleared K193289

FastStroke, CT Perfusion 4D

GE Medical Systems SCS

Analyzes CT data to display head and neck vasculature and CT perfusion to generate regional blood-flow, blood-volume, mean-transit-time, and capillary-permeability images.

Modality
CT/CTA
Anatomy
Brain
Decision
2020-11-12
FDA-cleared K192962

icobrain-ctp

Icometrix NV

Analyzes and communicates dynamic CT-perfusion datasets.

Modality
CT/CTA
Anatomy
Brain
Decision
2020-02-28
FDA-cleared K192832

Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i

Canon Medical Systems Corporation

Aquilion Prime SP with AiCE-i supports the labeled CT acquisition, reconstruction, visualization, and professional-interpretation workflow for the cleared scanner configuration.

Modality
CT/CTA
Anatomy
Multi-region
Decision
2020-02-21
FDA-cleared K192956

Auto Positioning

GE Hangwei Medical Systems, Co., Ltd.

Auto Positioning uses 3D patient-position information and the selected CT protocol to suggest scout range, orientation, table height, and collision checks before a...

Modality
CT/CTA
Anatomy
Multi-region
Decision
2020-01-16
FDA-cleared K182901

Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE

Canon Medical Systems Corporation

Aquilion Precision V8.8 is an ultra-high-resolution whole-body CT system; its AiCE deep-convolutional reconstruction is limited in this clearance to abdomen and pelvis...

Modality
CT/CTA
Anatomy
Multi-region
Decision
2019-07-05
FDA-cleared K181247

Vitrea CT Brain Perfusion

Vital Images, Inc.

Non-invasive post-processing for brain perfusion that calculates CBF, CBV, bolus timing/TTP, and MTT.

Modality
CT/CTA
Anatomy
Brain
Decision
2018-11-20
FDA-cleared K180161

Viz CTP

Viz.ai, Inc.

Image processing, analysis, and communication of dynamic brain CT perfusion datasets to calculate perfusion parameters for review by trained professionals.

Modality
CT/CTA
Anatomy
Brain
Decision
2018-04-20