FDA-cleared K161382
DIACARDIO, LTD.
LVivo Software Application is intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular...
- Modality
- MRI
- Anatomy
- Heart
- Decision
- 2016-07-28
FDA-cleared K191585
TeraRecon Inc.
Image analysis/processing for Heart using Radiotherapy planning imaging.
- Modality
- Radiotherapy planning imaging
- Anatomy
- Heart
- Decision
- 2019-07-12
FDA-cleared K183274
HeartVista, Inc.
Image analysis/processing for Heart using MRI.
- Modality
- MRI
- Anatomy
- Heart
- Decision
- 2019-10-18
FDA-cleared K223855
FEops nv
Image analysis/processing for Heart using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Heart
- Decision
- 2023-06-06
FDA-cleared K241038
Circle Cardiovascular Imaging
Image analysis/processing for Heart using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Heart
- Decision
- 2024-06-07
FDA-cleared K241380
Diagnoly
Image analysis/processing for Heart using Ultrasound.
- Modality
- Ultrasound
- Anatomy
- Heart
- Decision
- 2024-09-11
FDA-cleared K241312
TeraRecon,Inc.
Image analysis/processing for Heart using MRI.
- Modality
- MRI
- Anatomy
- Heart
- Decision
- 2024-11-05
FDA-cleared K243065
Caption Health, Inc.
Image analysis/processing for Heart using Mammography/DBT.
- Modality
- Mammography/DBT
- Anatomy
- Heart
- Decision
- 2025-01-15
FDA-cleared K242807
Deski
Image analysis/processing for Heart using Mammography/DBT.
- Modality
- Mammography/DBT
- Anatomy
- Heart
- Decision
- 2025-04-04
FDA-cleared K251837
Artrya Limited
Image analysis/processing for Heart using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Heart
- Decision
- 2025-08-20
FDA-cleared K251656
Careverse Technology Pte. Ltd.
Image analysis/processing for Heart using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Heart
- Decision
- 2025-09-04
FDA-cleared K252105
Ligence, UAB
Image analysis/processing for Heart using Radiotherapy planning imaging.
- Modality
- Radiotherapy planning imaging
- Anatomy
- Heart
- Decision
- 2025-09-26
FDA-cleared K251027
Circle Cardiovascular Imaging, Inc.
Image analysis/processing for Heart using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Heart
- Decision
- 2025-10-27