510(k) K213731
K213731 is an FDA 510(k) premarket notification submitted by Ever Fortune.Ai, Co., Ltd. for the device "EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows". The FDA issued a decision of Substantially Equivalent on May 31, 2022. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Ever Fortune.Ai, Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 31, 2022
- Date Received
- November 26, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Tomography, Computed, Emission
- Device Class
- Class II
- Regulation Number
- 892.1200
- Review Panel
- RA
- Submission Type