FDA 510(k)

EFAI ChestSuite XR Pleural Effusion Assessment System

K-Number: K222076 · 2022-09-08

Decision Date2022-09-08

Product CodeQFM

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

EFAI ChestSuite XR Pleural Effusion Assessment System is the device name listed in this FDA 510(k) record. The listed applicant is Ever Fortune.Ai, Co., Ltd.. It received FDA 510(k) clearance on 2022-09-08 under 510(k) number K222076. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EFAI ChestSuite XR Pleural Effusion Assessment System?

EFAI ChestSuite XR Pleural Effusion Assessment System is a medical device that received FDA 510(k) clearance on 2022-09-08. The listed applicant is Ever Fortune.Ai, Co., Ltd.. The 510(k) number is K222076.

When did EFAI ChestSuite XR Pleural Effusion Assessment System receive FDA 510(k) clearance?

EFAI ChestSuite XR Pleural Effusion Assessment System received FDA 510(k) clearance on 2022-09-08, under 510(k) number K222076.

Who is the listed applicant for EFAI ChestSuite XR Pleural Effusion Assessment System?

The FDA 510(k) record lists Ever Fortune.Ai, Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EFAI ChestSuite XR Pleural Effusion Assessment System?

The FDA product code for EFAI ChestSuite XR Pleural Effusion Assessment System is QFM.

Other records listing Ever Fortune.Ai, Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253163EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)K251306Seg Pro V3 (RT-300)K242821EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)K241923EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)K234042EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)K240291EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM

View all 15 devices →

Related Devices (Code: QFM)

K253751CXRDetectAINeurocareai, Inc. (Dba Savelife.Ai)K252954MammoSightAINeurocareai, Inc. (Dba Savelife.Ai)K252482CogNet AI-MT+Medcognetics, Inc.K250831Annalise EnterpriseAnnalise-Ai K243808Rayvolve PTX-PEAZmed K243548BriefCase-TriageAidoc Medical , Ltd.

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.