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510(k) K211257

EFAI PACS Picture Archiving and Communication System by Ever Fortune.Ai, Co., Ltd. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2021
Date Received
April 26, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

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  • K221552 — EFAI ChestSuite XR Pneumothorax Assessment System (November 8, 2022)
  • K222076 — EFAI ChestSuite XR Pleural Effusion Assessment System (September 8, 2022)

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