Cleared Traditional

K213731 - EFAI CARDIOSUITE SPECT Myocardial Perfu...

K213731 is an FDA 510(k) clearance for EFAI CARDIOSUITE SPECT Myocardial Perfu..., manufactured by Ever Fortune.Ai, Co., Ltd.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K213731 · Ever Fortune.Ai, Co., Ltd. · Radiology device
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May 2022
Decision
186d
Days
Class 2
Risk

K213731 is an FDA 510(k) clearance for the EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Ever Fortune.Ai, Co., Ltd. (Taichung City, TW). The FDA issued a Cleared decision on May 31, 2022 after a review of 186 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ever Fortune.Ai, Co., Ltd. devices

FDA 510(k) Submission Details - K213731

510(k) Number K213731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2021
Decision Date May 31, 2022
Days to Decision 186 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 107d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPS Device Classification - Class 2, Special Controls

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - KPS System, Tomography, Computed, Emission

All 248
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