EFAI ChestSuite XR Pleural Effusion Assessment System
FDA 510(k) K222076 · Ever Fortune.Ai, Co., Ltd.
Submission
- Device name
- EFAI ChestSuite XR Pleural Effusion Assessment System
- Applicant
- Ever Fortune.Ai, Co., Ltd.
Taichung City, TW - Received
- July 14, 2022
- Decision date
- September 8, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QFM – Radiological Computer-Assisted Prioritization Software For Lesions
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2080
- Specialty
- Radiology
Radiological computer-assisted prioritization software for lesions is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on…
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Questions and answers
When was EFAI ChestSuite XR Pleural Effusion Assessment System cleared by the FDA?
EFAI ChestSuite XR Pleural Effusion Assessment System (K222076) received a 510(k) decision of Substantially Equivalent on September 8, 2022, 56 days after the submission was received.
What is the product code of K222076?
The FDA product code is QFM – Radiological Computer-Assisted Prioritization Software For Lesions, a Class II (moderate risk) device regulated under 21 CFR 892.2080.