FDA source first
Profiles start with FDA file numbers, decision dates, and public source links before vendor claims are summarized.
Public beta - FDA-cleared radiology AI directory
Find FDA-cleared radiology AI tools by modality, use case, vendor, and workflow fit.
A source-linked Parikh Radiology directory for comparing radiology AI solutions with FDA decision details, public evidence links, buyer-fit caveats, and correction paths kept visible.
Listings 1230
Vendors 546
Modalities 14
Use cases 24
Latest FDA decision in dataset: 2026-06-29
Dataset last verified: August 31, 2026
How to use it
Start with regulatory traceability, then verify workflow fit.
Use the directory to build a shortlist, compare practical unknowns, and open the source ledger before contacting vendors. Final clinical, operational, security, billing, and purchasing decisions still need local review.
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By modality
Methodology
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Unknowns stay visible
Pricing, deployment, integration, and evidence gaps remain labeled unknown until public sources or exact-version documentation support an update.
Corrections are welcomed
Vendors and readers can submit source-backed corrections through a visible workflow tied to each profile.
Balanced sample
Representative listings across modalities
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
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
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
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
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
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
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
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
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