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FDA 510(k)

SENYINT Remote Consultation System

K-Number: K162727 · 2018-02-08

ApplicantDalian Senyint Digital Medical System Co., Ltd.
Decision Date2018-02-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SENYINT Remote Consultation System is a medical device manufactured by Dalian Senyint Digital Medical System Co., Ltd.. It received FDA 510(k) clearance on 2018-02-08 under approval number K162727. 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 SENYINT Remote Consultation System?

SENYINT Remote Consultation System is a medical device that received FDA 510(k) clearance on 2018-02-08. It is manufactured by Dalian Senyint Digital Medical System Co., Ltd.. The 510(k) number is K162727.

When was SENYINT Remote Consultation System approved by the FDA?

SENYINT Remote Consultation System received FDA 510(k) clearance on 2018-02-08, under approval number K162727.

What company makes SENYINT Remote Consultation System?

SENYINT Remote Consultation System is manufactured by Dalian Senyint Digital Medical System Co., Ltd..

What is the FDA product code for SENYINT Remote Consultation System?

The FDA product code for SENYINT Remote Consultation System is LLZ.

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) 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) PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025)

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Official Source

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

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