Efai Pacs Picture Archiving and Communication System Pro
FDA 510(k) K232100 · Ever Fortune.Ai, Co., Ltd.
510(k) numberK232100
Submission
- Device name
- Efai Pacs Picture Archiving and Communication System Pro
- Applicant
- Ever Fortune.Ai, Co., Ltd.
Taichung City, TW - Received
- July 14, 2023
- Decision date
- August 8, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Efai Pacs Picture Archiving and Communication System Pro cleared by the FDA?
Efai Pacs Picture Archiving and Communication System Pro (K232100) received a 510(k) decision of Substantially Equivalent on August 8, 2023, 25 days after the submission was received.
What is the product code of K232100?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.