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FDA 510(k)

EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows

K-Number: K213731 · 2022-05-31

ApplicantEver Fortune.Ai, Co., Ltd.
Decision Date2022-05-31
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows is a medical device manufactured by Ever Fortune.Ai, Co., Ltd.. It received FDA 510(k) clearance on 2022-05-31 under approval number K213731. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows?

EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows is a medical device that received FDA 510(k) clearance on 2022-05-31. It is manufactured by Ever Fortune.Ai, Co., Ltd.. The 510(k) number is K213731.

When was EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows approved by the FDA?

EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows received FDA 510(k) clearance on 2022-05-31, under approval number K213731.

What company makes EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows?

EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows is manufactured by Ever Fortune.Ai, Co., Ltd..

What is the FDA product code for EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows?

The FDA product code for EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows is KPS.

Related Clinical Trials

NCT07531394 Safety and Efficacy of Remote Ischemic Conditioning in Patients With Acute Myocardial Injury Following Acute Ischemic Stroke NOT_YET_RECRUITING NCT02515812 Comparative Study of Cardiac Adrenergic Function Explored by I-123-MIBG and CZT Camera (D-SPECT) Versus Anger Camera in Patients With Heart Failure COMPLETED

Related PubMed Literature

PMID: 41524152 Securing data management systems in perfusion: A narrative review on cybersecurity and clinical risk. Perfusion (2026)

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Related Devices (Code: KPS)

K161740D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd. K162736Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CTSiemens Medical Solutions USA, Inc. K161674QuantumCamDdd-Diagnostic A/S K162337Symbia 6.5Siemens Medical Solutions USA, Inc. K161574Discovery MIGe Medical Systems, LLC K161631MAMMIGeneral Equipment For Medical Imaging

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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