FDA-approved P150043
QVCAD System
QView Medical, Inc.
Image analysis/processing
- Modality
- Radiological images; modality varies or is not specified in FDA list
- Anatomy
- N/A
- Decision
- 2016-11-09
Use case
Radiological images; modality varies or is not specified in FDA list workflow radiology AI tools
A buyer-oriented shortlist for radiological images; modality varies or is not specified in fda list workflow. Confirm exact intended use and local validation needs before any pilot or procurement decision.
FDA-approved P160009
PowerLook® Tomo Detection Software
iCAD Inc
Image analysis/processing
- Modality
- Radiological images; modality varies or is not specified in FDA list
- Anatomy
- N/A
- Decision
- 2017-03-24
FDA-cleared K183593
Lung Vision System
Body Vision Medical Ltd.
Image analysis/processing
- Modality
- Radiological images; modality varies or is not specified in FDA list
- Anatomy
- Chest/Lung
- Decision
- 2019-04-18
FDA-authorized DEN190040
Caption Guidance
Bay Labs, Inc.
Acquisition guidance/quality control
- Modality
- Radiological images; modality varies or is not specified in FDA list
- Anatomy
- N/A
- Decision
- 2020-02-07
FDA-cleared K200356
MEDO ARIA
Medo.ai
Image analysis/processing.
- Modality
- Radiological images; modality varies or is not specified in FDA list
- Anatomy
- N/A
- Decision
- 2020-06-11
FDA-cleared K193294
AI-Rad Companion Engine
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- Radiological images; modality varies or is not specified in FDA list
- Anatomy
- N/A
- Decision
- 2020-07-10
FDA-cleared K211788
HALO
Nico.Lab B.V.
Image analysis/processing.
- Modality
- Radiological images; modality varies or is not specified in FDA list
- Anatomy
- N/A
- Decision
- 2021-07-08
FDA-cleared K211966
Segment 3DPrint
Medviso AB
Image analysis/processing.
- Modality
- Radiological images; modality varies or is not specified in FDA list
- Anatomy
- N/A
- Decision
- 2022-05-06
FDA-cleared K230252
OFIX MIS App
Orthofix US LLC
Image analysis/processing.
- Modality
- Radiological images; modality varies or is not specified in FDA list
- Anatomy
- N/A
- Decision
- 2023-09-26
FDA-cleared K231955
aprevo® Digital Segmentation
Carlsmed, Inc.
Image analysis/processing.
- Modality
- Radiological images; modality varies or is not specified in FDA list
- Anatomy
- N/A
- Decision
- 2023-11-03
FDA-cleared K241847
Imbio PHA (4.0.0)
Imbio, Inc
Image analysis/processing.
- Modality
- Radiological images; modality varies or is not specified in FDA list
- Anatomy
- N/A
- Decision
- 2024-08-30
FDA-cleared K241546
aiCockpit AI Viewer
Fovia, Inc.
Image analysis/processing.
- Modality
- Radiological images; modality varies or is not specified in FDA list
- Anatomy
- N/A
- Decision
- 2025-02-26