FDA-cleared K253172

MediAI-OA

Crescom Co., Ltd.

Assist trained professionals in assessing radiographic knee osteoarthritis and its sclerosis, joint-space-narrowing, and osteophyte features on standing fixed-flexion knee...

Modality
X-ray/Radiography
Anatomy
Knee joint
Decision
2026-06-15
FDA-cleared K253930

Overjet Iris Intelligent Imaging System

Overjet, Inc.

Overjet Iris is a web-based dental PACS for storing, viewing, and supporting image-quality review of two-dimensional intraoral radiographs, panoramic images, and color photographs.

Modality
X-ray/Radiography
Anatomy
Teeth and maxillofacial anatomy
Decision
2026-04-10
FDA-cleared K250525

Second OpinionĀ® Panoramic

Pearl, Inc.

Second Opinion Panoramic is an automated image-processing aid that identifies and marks regions of interest for caries, periapical radiolucency, and impacted third molars on...

Modality
X-ray/Radiography
Anatomy
Permanent teeth; caries, periapical radiolucency, and impacted third molars
Decision
2025-11-14
FDA-cleared K251002

Videa Dental AI

VideaHealth Inc.

Analyzes bitewing, periapical, and panoramic intraoral radiographs from patients aged 3 years and older to identify and localize specified suspected dental findings, historical...

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial
Decision
2025-09-19
FDA-cleared K250738

YSIO X.pree

Siemens Medical Solutions

YSIO X.pree is a digital X-ray system for whole-body radiographic imaging, including skull, chest, abdomen, and extremities, to support diagnostic and therapeutic decisions.

Modality
X-ray/Radiography
Anatomy
Whole body, including skull; chest; abdomen; and extremities
Decision
2025-07-31
FDA-cleared K241620

ChestView US

Gleamer SAS

Concurrent reading aid for adult frontal and lateral chest radiographs, marking suspected nodules, pleural-space abnormalities, mediastinal/hilar abnormalities and consolidations.

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2025-02-27
FDA-cleared K242522

Second Opinion CC

Pearl Inc.

Second Opinion CC assists dental health professionals as a second reader for caries on bitewing and periapical radiographs of permanent teeth in patients 19 years or older,...

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial
Decision
2025-01-16
FDA-cleared K241681

Overjet Image Enhancement Assist

Overjet Inc

Overjet Image Enhancement Assist provides optional image-quality enhancement for dental radiographs. The FDA material describes learning-based noise reduction for bitewing and...

Modality
X-ray/Radiography
Anatomy
Teeth and maxillofacial structures
Decision
2024-09-09
FDA-cleared K231396

CEPHX- Cephalometric Analysis Software

Orca Dental AI LTD

Cephalometric image analysis, simulation, visual treatment objective support, and consultation for dental and orthodontic professionals treating patients aged 14 years and older.

Modality
X-ray/Radiography
Anatomy
Head/Neck
Decision
2024-01-31
FDA-cleared K232384

Videa Dental Assist

VideaHealth, Inc.

Identify and localize listed dental findings, historical treatments, and normal anatomy on bitewing, periapical, and panoramic intraoral radiographs for patients aged 3 years and...

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial (suspected findings, historical treatments, and normal anatomy)
Decision
2023-12-15
FDA-cleared K223621

DeepXray

Alpha Intelligence Manifolds, Inc.

DeepXray is a fully automated CR or DX radiographic image-processing device intended to aid trained medical professionals in measuring minimum joint-space width, assessing...

Modality
X-ray/Radiography
Anatomy
Knee; radiographic osteoarthritis features
Decision
2023-09-08
FDA-cleared K210365

Second Opinion

Pearl Inc.

Second Opinion is a concurrent-reading aid for dental professionals reviewing bitewing and periapical radiographs of permanent teeth in patients aged 12 years and older.

Modality
X-ray/Radiography
Anatomy
Permanent teeth; caries, restoration margins, calculus, periapical radiolucency, and dental restorations
Decision
2022-03-04
FDA-cleared K212654

Micro C Medical Imaging System, M01

OXOS Medical, Inc.

Micro C Medical Imaging System M01 is a handheld or portable general-purpose X-ray system for qualified clinicians to obtain diagnostic static or serial radiographic exposures of...

Modality
X-ray/Radiography
Anatomy
Adult and pediatric distal extremities
Decision
2022-02-04
FDA-cleared K212690

qXR-BT

Qure.ai Technologies

The qXR-BT device is intended to generate a secondary digital chest X-ray image that facilitates confirmation of the position of a breathing tube and an anatomical landmark on...

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2021-12-21
FDA-cleared K212269

Intelligent NR

Canon Inc.

Intelligent NR is a radiographic image-processing function for supported X-ray studies in the exact K212269 workflow; processed images are reviewed by qualified professionals and...

Modality
X-ray/Radiography
Anatomy
Chest and other labeled radiographic anatomy
Decision
2021-09-17
FDA-cleared K203696

RBknee

Radiobotics ApS

The Radiobotics' Rbknee is a fully -automated image processing software device intended to aid medical professionals in the analysis and reporting of weight-bearing AP/PA...

Modality
X-ray/Radiography
Anatomy
MSK
Decision
2021-08-27
FDA-cleared K192320

HealthCXR

Zebra Medical Vision, Ltd.

The Zebra HealthCXR device is a software workflow tool designed to aid the clinical assessment of adult Chest X-ray cases with features suggestive of pleural effusion in the...

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2019-11-26
FDA-cleared K190362

HealthPNX

Zebra Medical Vision Ltd.

The Zebra Pneumothorax device is a software tool designed to aid the clinical assessment of adult Chest X-Ray cases with features suggestive of Pneumothorax in the medical care...

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2019-05-06
FDA-cleared K111776

DELTAVIEW MODEL 2.1

RIVERAIN MEDICAL GROUP,LLC

DeltaView is a dedicated post-processing application which registers current and prior chest exams to provide an image that shows areas of change.

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2011-12-28