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FDA 510(k)

EFAI PACS Picture Archiving and Communication System

K-Number: K211257 · 2021-09-10

ApplicantEver Fortune.Ai, Co., Ltd.
Decision Date2021-09-10
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EFAI PACS Picture Archiving and Communication System is a medical device manufactured by Ever Fortune.Ai, Co., Ltd.. It received FDA 510(k) clearance on 2021-09-10 under approval number K211257. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EFAI PACS Picture Archiving and Communication System?

EFAI PACS Picture Archiving and Communication System is a medical device that received FDA 510(k) clearance on 2021-09-10. It is manufactured by Ever Fortune.Ai, Co., Ltd.. The 510(k) number is K211257.

When was EFAI PACS Picture Archiving and Communication System approved by the FDA?

EFAI PACS Picture Archiving and Communication System received FDA 510(k) clearance on 2021-09-10, under approval number K211257.

What company makes EFAI PACS Picture Archiving and Communication System?

EFAI PACS Picture Archiving and Communication System is manufactured by Ever Fortune.Ai, Co., Ltd..

What is the FDA product code for EFAI PACS Picture Archiving and Communication System?

The FDA product code for EFAI PACS Picture Archiving and Communication System is LLZ.

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Related PubMed Literature

PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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