FDA-cleared K190362
HealthPNX
Zebra Medical Vision Ltd.
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2019-05-06
Use case
X-ray/Radiography workflow radiology AI tools
A buyer-oriented shortlist for x-ray/radiography workflow. Confirm exact intended use and local validation needs before any pilot or procurement decision.
FDA-cleared K183182
Critical Care Suite
GE Medical Systems, LLC.
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2019-08-12
FDA-cleared K192320
HealthCXR
Zebra Medical Vision, Ltd.
Image analysis/processing for Chest/Lung using X-ray/Radiography.
- Modality
- X-ray/Radiography
- Anatomy
- Chest/Lung
- Decision
- 2019-11-26
FDA-cleared K192279
PhantomMSK Trauma
OrthoGrid Systems Inc.
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2019-12-07
FDA-cleared K191556
Red Dot
Behold.AI Technologies Limited
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2020-02-28
FDA-cleared K193300
AIMI-Triage CXR PTX
RADLogics, Inc.
Image analysis/processing for Chest/Lung using X-ray/Radiography.
- Modality
- X-ray/Radiography
- Anatomy
- Chest/Lung
- Decision
- 2020-04-08
FDA-cleared K202441
Eclipse II with Smart Noise Cancellation
Carestream Health, Inc.
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2021-04-02
FDA-cleared K210666
Chest-CAD
Imagen Technologies, Inc
Image analysis/processing for Chest/Lung using X-ray/Radiography.
- Modality
- X-ray/Radiography
- Anatomy
- Chest/Lung
- Decision
- 2021-07-20
FDA-cleared K203696
RBknee
Radiobotics ApS
Indications for Use statement. Please note that the 510(k) submission was not re-reviewed.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2021-08-27
FDA-cleared K201560
Auto Lung Nodule Detection
Samsung Electronics Co.,Ltd.
Image analysis/processing for Chest/Lung using X-ray/Radiography.
- Modality
- X-ray/Radiography
- Anatomy
- Chest/Lung
- Decision
- 2021-08-31
FDA-cleared K212269
Intelligent NR
Canon Inc.
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2021-09-17
FDA-cleared K211733
Lunit INSIGHT CXR Triage
Lunit Inc.
Image analysis/processing for Chest/Lung using X-ray/Radiography.
- Modality
- X-ray/Radiography
- Anatomy
- Chest/Lung
- Decision
- 2021-11-10
FDA-cleared K211803
HealthPPT
Zebra Medical Vision Ltd.
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2021-12-15
FDA-cleared K212690
qXR-BT
Qure.ai Technologies
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2021-12-21
FDA-cleared K213307
Eclipse II with Smart Noise Cancellation
Carestream Health, Inc.
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2022-01-14
FDA-cleared K212654
Micro C Medical Imaging System, M01
OXOS Medical, Inc.
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2022-02-04
FDA-cleared K213941
Annalise Enterprise CXR Triage Pneumothorax
Annalise-AI
Image analysis/processing for Chest/Lung using X-ray/Radiography.
- Modality
- X-ray/Radiography
- Anatomy
- Chest/Lung
- Decision
- 2022-02-24
FDA-cleared K213566
ClearRead Xray Pneumothorax
Riverain Technologies, Inc.
Image analysis/processing for Chest/Lung using X-ray/Radiography.
- Modality
- X-ray/Radiography
- Anatomy
- Chest/Lung
- Decision
- 2022-03-10
FDA-cleared K213795
Videa Caries Assist
VideaHealth, Inc
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2022-04-21
FDA-cleared K221241
DrAid for Radiology v1
VinBrain Joint Stock Company
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2022-09-01
FDA-cleared K222076
EFAI ChestSuite XR Pleural Effusion Assessment System
Ever Fortune.AI Co., Ltd.
Image analysis/processing for Chest/Lung using X-ray/Radiography.
- Modality
- X-ray/Radiography
- Anatomy
- Chest/Lung
- Decision
- 2022-09-08
FDA-cleared K213353
Aorta-CAD
Imagen Technologies, Inc
Image analysis/processing for Cardiovascular using X-ray/Radiography.
- Modality
- X-ray/Radiography
- Anatomy
- Cardiovascular
- Decision
- 2022-09-20
FDA-cleared K221552
EFAI ChestSuite XR Pneumothorax Assessment System
Ever Fortune AI Co., Ltd.
Image analysis/processing for Chest/Lung using X-ray/Radiography.
- Modality
- X-ray/Radiography
- Anatomy
- Chest/Lung
- Decision
- 2022-11-08
FDA-cleared K220928
Overjet Calculus Assist
Overjet Inc.
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2022-12-16
FDA-cleared K223296
Videa Perio Assist
VideaHealth, Inc.
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2023-02-06
FDA-cleared K223490
FlightPlan for Embolization
GE Medical Systems SCS
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2023-03-21
FDA-cleared K222036
MPXA-2000
Medipixel, Inc.
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2023-03-22
FDA-cleared K222746
Overjet Caries Assist
Overjet, Inc.
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2023-03-27
FDA-cleared K221921
DTX Studio Clinic 3.0
Nobel Biocare AB
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2023-03-28
FDA-cleared K222179
Annalise Enterprise CXR Triage Trauma
Annalise-AI Pty Ltd
Image analysis/processing for Chest/Lung using X-ray/Radiography.
- Modality
- X-ray/Radiography
- Anatomy
- Chest/Lung
- Decision
- 2023-03-28
FDA-cleared K222268
Annalise Enterprise CXR Triage Trauma
Annalise-AI Pty Ltd
Image analysis/processing for Chest/Lung using X-ray/Radiography.
- Modality
- X-ray/Radiography
- Anatomy
- Chest/Lung
- Decision
- 2023-03-28
FDA-cleared K223646
IB Lab LAMA
IB Lab GmbH
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2023-06-16
FDA-cleared K223133
VisiRad XR
Imidex Inc.
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2023-08-03
FDA-cleared K230899
qXR-PTX-PE
Qure.ai Technologies
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2023-08-22
FDA-cleared K223639
VisAble.IO
TechsoMed
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2023-08-28
FDA-cleared K223621
DeepXray
Alpha Intelligence Manifolds, Inc.
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2023-09-08
FDA-cleared K223811
Lung-CAD
Imagen Technologies, Inc
Image analysis/processing for Chest/Lung using X-ray/Radiography.
- Modality
- X-ray/Radiography
- Anatomy
- Chest/Lung
- Decision
- 2023-09-13
FDA-cleared K231678
Overjet Periapical Radiolucency Assist
Overjet, Inc
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2023-09-21
FDA-cleared K231149
qXR-CTR
Qure.ai Technologies
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2023-09-22
FDA-cleared K230085
Lung-CAD
Imagen Technologies, Inc
Image analysis/processing for Chest/Lung using X-ray/Radiography.
- Modality
- X-ray/Radiography
- Anatomy
- Chest/Lung
- Decision
- 2023-10-03
FDA-cleared K231001
DeepTek CXR Analyzer v1.0
DeepTek Medical Imaging Pvt Ltd
Image analysis/processing for Chest/Lung using X-ray/Radiography.
- Modality
- X-ray/Radiography
- Anatomy
- Chest/Lung
- Decision
- 2023-10-05
FDA-cleared K230144
Denti.AI Detect
Denti.AI Technology, Inc.
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2023-10-06
FDA-cleared K223754
BraveCX
Bering Ltd
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2023-11-09
FDA-cleared K232440
Adravision Perio
Adra Corporation
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2023-12-05
FDA-cleared K231898
DTX Studio Clinic (4.0)
Nobel Biocare AB
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2023-12-08
FDA-cleared K232384
Videa Dental Assist
VideaHealth, Inc.
Image analysis/processing for Dental/Maxillofacial using X-ray/Radiography.
- Modality
- X-ray/Radiography
- Anatomy
- Dental/Maxillofacial
- Decision
- 2023-12-15
FDA-cleared K231805
qXR-LN
Qure.ai Technologies
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2023-12-22
FDA-cleared K231917
VEA Align
EOS imaging
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2024-01-05
FDA-cleared K231871
Radify Triage
Envisionit DeepAI Ltd
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2024-01-17
FDA-cleared K233590
Overjet Charting Assist
Overjet, Inc
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2024-02-23
FDA-cleared K233738
Overjet Caries Assist-Pediatric
Overjet, Inc
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2024-03-04
FDA-cleared K240773
VisAble.IO
Techsomed
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2024-04-15
FDA-cleared K232410
SmartChest
Milvue
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2024-05-10
FDA-cleared K233543
YSIO X.pree
Siemens Medical Solutions
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2024-05-21
FDA-cleared K233662
Radiography 7300 C
Philips Medical Systems DMC GmbH
Image analysis/processing
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2024-06-13
FDA-cleared K241684
Overjet Charting Assist
Overjet, Inc
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2024-08-27
FDA-cleared K240003
Velmeni for Dentists (V4D)
Velmeni Inc.
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2024-08-30
FDA-cleared K241681
Overjet Image Enhancement Assist
Overjet Inc
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2024-09-09
FDA-cleared K241439
VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage
Vuno Inc.
Image analysis/processing for Chest/Lung using X-ray/Radiography.
- Modality
- X-ray/Radiography
- Anatomy
- Chest/Lung
- Decision
- 2024-11-15
FDA-cleared K241696
Ortho AI
Ortho AI LLC
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2025-01-02
FDA-cleared K242821
EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)
Ever Fortune.AI, Co., Ltd.
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2025-02-20
FDA-cleared K243808
Rayvolve PTX-PE
AZmed
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2025-03-21
FDA-cleared K243769
QFR (3.0)
QFR Solutions bv
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2025-04-04
FDA-cleared K242437
Smile Dx®
Cube Click, Inc.
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2025-05-14
FDA-cleared K243005
AudaxCeph Cephalogram Analysis Software
Audax d.o.o.
Image analysis/processing for Head/Neck using X-ray/Radiography.
- Modality
- X-ray/Radiography
- Anatomy
- Head/Neck
- Decision
- 2025-05-30
FDA-cleared K250738
YSIO X.pree
Siemens Medical Solutions
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2025-07-31
FDA-cleared K250755
DS Core Diagnosis
Dentsply Sirona Inc.
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2025-08-12
FDA-cleared K250788
Definium Tempo Select
GE Hualun Medical Systems Co., Ltd
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2025-08-28
FDA-cleared K250753
VELMENI for DENTISTS (V4D)
Velmeni Inc.
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2025-09-02
FDA-cleared K251408
OsteoSight Hip (v1)
Naitive Technologies Ltd
Image analysis/processing for Hip using X-ray/Radiography.
- Modality
- X-ray/Radiography
- Anatomy
- Hip
- Decision
- 2025-09-02
FDA-cleared K251931
BioTraceIO Vision (V1.7)
Techsomed Medical Technologies
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2025-09-08
FDA-cleared K251002
Videa Dental AI
VideaHealth Inc.
Image analysis/processing for Dental/Maxillofacial using X-ray/Radiography.
- Modality
- X-ray/Radiography
- Anatomy
- Dental/Maxillofacial
- Decision
- 2025-09-19
FDA-cleared K251167
uDR Aurora CX
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2025-09-19
FDA-cleared K251355
X1-FFR
Spectrawave, Inc.
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2025-10-17
FDA-cleared K250264
SugarBug (1.x)
Bench7, Inc.
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2025-11-07
FDA-cleared K251078
AutoDensity
Eos Imaging
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2025-11-14
FDA-cleared K252086
DTX Studio Assist
Nobel Biocare C/O Medicim NV
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2025-11-17
FDA-cleared K253269
OEC One CFD
Ge Hualun Medical Systems Co. , Ltd.
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2025-11-26
FDA-cleared K250914
MediAI-BA
Crescom Co., Ltd.
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2025-12-18