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FDA 510(k)

Essence 55S Large Monitor System

K-Number: K172969 · 2018-01-26

ApplicantShenyang Torch-Bigtide Digital Technology Co., Ltd.
Decision Date2018-01-26
Product CodeDXJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Essence 55S Large Monitor System is a medical device manufactured by Shenyang Torch-Bigtide Digital Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-01-26 under approval number K172969. The device is classified under product code DXJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Essence 55S Large Monitor System?

Essence 55S Large Monitor System is a medical device that received FDA 510(k) clearance on 2018-01-26. It is manufactured by Shenyang Torch-Bigtide Digital Technology Co., Ltd.. The 510(k) number is K172969.

When was Essence 55S Large Monitor System approved by the FDA?

Essence 55S Large Monitor System received FDA 510(k) clearance on 2018-01-26, under approval number K172969.

What company makes Essence 55S Large Monitor System?

Essence 55S Large Monitor System is manufactured by Shenyang Torch-Bigtide Digital Technology Co., Ltd..

What is the FDA product code for Essence 55S Large Monitor System?

The FDA product code for Essence 55S Large Monitor System is DXJ.

Related Clinical Trials

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Related PubMed Literature

PMID: 33371797 Developing a Qualification and Verification Strategy for Digital Tissue Image Analysis in Toxicological Pathology. Toxicologic pathology (2021) PMID: 28216355 Innovative postmarket device evaluation using a quality registry to monitor thoracic endovascular aortic repair in the treatment of aortic dissection. Journal of vascular surgery (2017)

Other Devices by Shenyang Torch-Bigtide Digital Technology Co., Ltd.

K201162Essence 55SP Large Monitor System

Related Devices (Code: DXJ)

K162012CARESCAPE Central Station V2GE Healthcare K170460Sorin ConnectSorin Group Deutschland GmbH K170537Nexxis OR, NexxisBarco N.V. K161880NIVR58-T kitBarco N.V. K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH K173107Vios Central Station Monitor Software, Vios Central Server SoftwareVios Medical, Inc.

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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