EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows— 510(k) K213731
Substantially EquivalentEver Fortune.Ai, Co., Ltd.
FDA 510(k) clearance K213731 for EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows, Substantially Equivalent on 2022-05-31. Applicant: Ever Fortune.Ai, Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Ever Fortune.Ai, Co., Ltd.
- Product code
- Code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taichung City, TW
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Data sourced from openFDA. This site is unofficial and independent of the FDA.