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EFAI ChestSuite XR Pneumothorax Assessment System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221552
510(k) Type
Traditional
Applicant
Ever Fortune AI Co., Ltd.
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
11/8/2022
Days to Decision
161 days
Submission Type
Summary

EFAI ChestSuite XR Pneumothorax Assessment System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221552
510(k) Type
Traditional
Applicant
Ever Fortune AI Co., Ltd.
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
11/8/2022
Days to Decision
161 days
Submission Type
Summary