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FDA 510(k)

TruPlan Computed Tomography (CT) Imaging Software

K-Number: K222593 · 2023-01-18

ApplicantCircle Cardiovascular Imaging, Inc.
Decision Date2023-01-18
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TruPlan Computed Tomography (CT) Imaging Software is a medical device manufactured by Circle Cardiovascular Imaging, Inc.. It received FDA 510(k) clearance on 2023-01-18 under approval number K222593. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TruPlan Computed Tomography (CT) Imaging Software?

TruPlan Computed Tomography (CT) Imaging Software is a medical device that received FDA 510(k) clearance on 2023-01-18. It is manufactured by Circle Cardiovascular Imaging, Inc.. The 510(k) number is K222593.

When was TruPlan Computed Tomography (CT) Imaging Software approved by the FDA?

TruPlan Computed Tomography (CT) Imaging Software received FDA 510(k) clearance on 2023-01-18, under approval number K222593.

What company makes TruPlan Computed Tomography (CT) Imaging Software?

TruPlan Computed Tomography (CT) Imaging Software is manufactured by Circle Cardiovascular Imaging, Inc..

What is the FDA product code for TruPlan Computed Tomography (CT) Imaging Software?

The FDA product code for TruPlan Computed Tomography (CT) Imaging Software is LLZ.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT02193425 Reliability of the Human Brain Connectome COMPLETED NCT06797765 Optical Coherence Tomography Angiography in Neurological Disease COMPLETED NCT01421953 Assessment of 4D 18F-FDG PET-CT in Radiotherapy for Non Small Cell Lung Cancers COMPLETED NCT02710916 SD-OCT Multimodal Analysis in GLaucoma COMPLETED

Related PubMed Literature

PMID: 42086270 Abdominopelvic computed tomography during pregnancy and the risk of congenital malformations: protocol for a nationwide population-based cohort study in South Korea. BMJ open (2026) PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 41883556 A clinician's quick‑start guide to implementing digital health innovations in the NHS - with lessons from a UK-deployed AI stroke imaging decision-support software. Digital health (2026) PMID: 41476571 Digital pathology imaging artificial intelligence in cancer research and clinical trials: An NCI workshop report. Journal of pathology informatics (2026)

Other Devices by Circle Cardiovascular Imaging, Inc.

K202212TruPlan K213998cvi42 Auto Imaging Software Application K242781cvi42 Software Application K251027cvi42 Coronary Plaque Software Application K250221StrokeSENS ASPECTS Software Application

Related Devices (Code: LLZ)

K161959ClearView cCADClearview Diagnostics, Inc. K163539Ez3D-i / E3Ewoosoft Co., Ltd. K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. K160852ZiaZetta Medical Technologies, LLC K162376CAAS MR 4D FlowPie Medical Imaging BV K161322CT CoPilotZepmed, LLC

Official Source

View on FDA Database →

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