510(k) K211257— EFAI PACS Picture Archiving and Communication System

Substantially Equivalent

Ever Fortune.Ai, Co., Ltd.

Clearance details

Applicant: Ever Fortune.Ai, Co., Ltd.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2021-04-26
Decision date: 2021-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taichung City, TW

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.