Efai Pacs Picture Archiving and Communication System Pro— 510(k) K232100
Substantially EquivalentEver Fortune.Ai, Co., Ltd.
FDA 510(k) clearance K232100 for Efai Pacs Picture Archiving and Communication System Pro, Substantially Equivalent on 2023-08-08. Applicant: Ever Fortune.Ai, Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Ever Fortune.Ai, Co., Ltd.
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Taichung City, TW
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Adverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.