FDA-cleared K202212
TruPlan
Circle Cardiovascular Imaging Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2021-02-19
Vendor
Circle Cardiovascular Imaging Inc.
6 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K213998
cvi42 Auto Imaging Software Application
Circle Cardiovascular Imaging Inc
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-07-28
FDA-cleared K222593
TruPlan Computed Tomography (CT) Imaging Software
Circle Cardiovascular Imaging, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-01-18
FDA-cleared K242781
cvi42 Software Application
Circle Cardiovascular Imaging Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-10-15
FDA-cleared K250221
StrokeSENS ASPECTS Software Application
Circle Cardiovascular Imaging Inc.
Image analysis/processing for Brain using PET/SPECT/Nuclear Medicine.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- Brain
- Decision
- 2025-07-01
FDA-cleared K251027
cvi42 Coronary Plaque Software Application
Circle Cardiovascular Imaging, Inc.
Image analysis/processing for Heart using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Heart
- Decision
- 2025-10-27