FDA-cleared radiology AI tools | Source-backed directory

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Representative FDA-cleared listings

Start with a balanced cross-modality sample

FDA-cleared K253628

Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)

Agada Medical, Ltd.

Auto-Seg and Spine Auto-Seg accept spine and pelvis CT images and provide three-dimensional segmentation and labels to support spine-surgery planning and assessment by spine...

Modality: CT/CTA
Anatomy: Spine
Decision: 2026-06-29

MSK and bone Quantification and segmentation

FDA-cleared K253969

ADAS 3D

Adas3D Medical S.L.

ADAS 3D supports visualization and analysis of MR and CT images of the heart for individual patients with cardiovascular disease, including patients with myocardial scar from...

Modality: Radiological images; modality varies or is not specified in FDA list
Anatomy: Heart; myocardial scar and cardiac structures
Decision: 2026-06-29

Radiotherapy planning Cardiac imaging Oncology quantification

FDA-cleared K260667

Alturion Series Diagnostic Ultrasound System

Philips Ultrasound, LLC

Alturion Series diagnostic ultrasound systems acquire and display ultrasound images and fluid-flow information for the labeled fetal, abdominal, cardiac, cephalic, obstetric,...

Modality: Ultrasound
Anatomy: Fetus; abdomen; pelvis; small organs; head; heart; peripheral vessels; musculoskeletal anatomy; ophthalmic; urologic organs; and lung
Decision: 2026-06-29

Cardiac imaging Ultrasound workflow

FDA-cleared K260714

MammoScreen® (5)

Therapixel

Flags calcifications, masses, asymmetries and architectural distortions on compatible FFDM or DBT screening examinations; management must not be based solely on MammoScreen output.

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2026-06-26

Breast imaging

FDA-cleared K253050

RadOncAI

Informai

RadOncAI provides AI-guided dose prediction from CT simulation and clinician-defined treatment-planning structures for adult head-and-neck malignant or benign disease.

Modality: Radiotherapy Planning Imaging
Anatomy: Head and neck
Decision: 2026-06-18

Radiotherapy planning

FDA-cleared K253172

MediAI-OA

Crescom Co., Ltd.

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

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2026-06-15

X-ray/Radiography workflow

FDA-cleared K253690

LungMaps

Siemens Healthineers AG

LungMaps processes one or more 2D lung MRI time series to support radiologist interpretation of ventilation and perfusion maps; it is not the sole source for diagnosis.

Modality: MRI
Anatomy: Chest/Lung
Decision: 2026-06-15

MRI workflow

FDA-cleared K260077

OrthoGrid Hip AI® 4.0

OrthoGrid Systems, Inc.

OrthoGrid Hip AI 4.0 analyzes two-dimensional C-arm fluoroscopic images to assist positioning of hip-replacement components during direct-anterior total hip arthroplasty.

Modality: Fluoroscopy/Angiography
Anatomy: Hip
Decision: 2026-05-29

Fluoroscopy/Angiography workflow

FDA-cleared K254013

SubtleHD-PET (1.x)

Subtle Medical, Inc.

SubtleHD-PET 1.x is image-processing software that reduces PET or PET/CT/PET-MR image noise for images acquired with any radiotracer within the labeled workflow.

Modality: PET/SPECT/Nuclear Medicine
Anatomy: Whole body and the body regions represented in PET studies
Decision: 2026-05-14

Nuclear medicine

FDA-cleared K253459

OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)

ABBOTT MEDICAL

Abbott OPTIS Mobile or Integrated Next with Ultreon 3.0 processes compatible coronary intravascular OCT data to support visualization, measurement, and interventional assessment...

Modality: Optical Coherence Tomography
Anatomy: Coronary arteries
Decision: 2026-04-24

Cardiac imaging Quantification and segmentation

FDA-cleared K260785

DS Core CBCT Anatomy

Dentsply Sirona

DS Core CBCT Anatomy uses CBCT and digital-impression data to provide tooth and jaw segmentation, inferior-alveolar-nerve-canal segmentation, panoramic-curve support, and...

Modality: CBCT
Anatomy: Teeth; jaws; and the inferior alveolar nerve canal
Decision: 2026-04-23

Quantification and segmentation

FDA-cleared K232023

Momentum Spine

Momentum Health Inc.

The Momentum Spine optical-contour-sensing mobile application quantifies asymmetries and assesses body angles and curve progression related to postural asymmetries, including...

Modality: Optical Surface Imaging
Anatomy: Torso and spine; postural asymmetry and scoliosis
Decision: 2023-10-04

MSK and bone Quantification and segmentation