510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Ever Fortune.Ai, Co., Ltd.

Taichung City, TW

Ever Fortune.Ai, Co., Ltd. appears in FDA device records in Taichung City, TW. FDA records list 15 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
15
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 15 510(k) clearances for Ever Fortune.Ai, Co., Ltd. between 2021 and 2026. The busiest year on record is 2022, with 5. The most recent is 2026, with 2.

Clearances by year, as a table
510(k) clearance decisions for Ever Fortune.Ai, Co., Ltd., by decision year
YearClearances
20211
20225
20233
20243
20251
20262
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253163EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)QASSubstantially Equivalent
K251306Seg Pro V3 (RT-300)QKBSubstantially Equivalent
K242821EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)QASSubstantially Equivalent
K241923EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)QASSubstantially Equivalent
K234042EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)QIHSubstantially Equivalent
K240291EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEMQASSubstantially Equivalent
K231025EFAI NeuroSuite CT ICH Assessment SystemQASSubstantially Equivalent
K231928EFAI RTSUITE CT HCAP-Segmentation SystemQKBSubstantially Equivalent
K232100Efai Pacs Picture Archiving and Communication System ProLLZSubstantially Equivalent
K221552EFAI ChestSuite XR Pneumothorax Assessment SystemQFMSubstantially Equivalent
K222076EFAI ChestSuite XR Pleural Effusion Assessment SystemQFMSubstantially Equivalent
K213731EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile WorkflowsKPSSubstantially Equivalent
K220264EFAI RTSuite CT HN-Segmentation SystemQKBSubstantially Equivalent
K212624EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment SystemQIHSubstantially Equivalent
K211257EFAI PACS Picture Archiving and Communication SystemLLZSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain