FDA-cleared K193220

AVIEW LCS

Coreline Soft Co., Ltd

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2020-05-05
FDA-cleared K200714

AVIEW

Coreline Soft Co., Ltd

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2020-08-26
FDA-cleared K201710

A View LCS

Coreline Soft Co., Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2020-10-16
FDA-cleared K220408

AVIEW RT ACS

Coreline Soft Co.,Ltd

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2022-11-10
FDA-cleared K214036

AVIEW

Coreline Soft Co.,Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-12-23
FDA-cleared K221592

AVIEW Lung Nodule CAD

Coreline Soft Co.,Ltd.

Image analysis/processing for Chest/Lung using CT/CTA.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2023-02-24
FDA-cleared K233211

AVIEW CAC

Coreline Soft Co., Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-03-29
FDA-cleared K243696

AVIEW CAC

Coreline Soft Co., Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-02-14
FDA-cleared K243689

AVIEW

Coreline Soft Co., Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-03-19
FDA-cleared K251203

AVIEW Lung Nodule CAD

Coreline Soft Co.,Ltd

Image analysis/processing for Chest/Lung using CT/CTA.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2025-12-03