Efai Pacs Picture Archiving and Communication System Pro— 510(k) K232100

Substantially Equivalent

Ever 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..

Clearance details

Applicant: Ever Fortune.Ai, Co., Ltd.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2023-07-14
Decision date: 2023-08-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Taichung City, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.