Essence 55S Large Monitor System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K172969 FDA 510(k)
- FDA Product Code
- DXJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2450 FDA 510(k)
- Regulation Number
- 870.2450 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Essence 55S Large Monitor System is a Display, Cathode-Ray Tube, Medical, designed for clinical monitoring applications. It provides high-resolution visual output for critical patient data, supporting real-time observation in cardiovascular settings. The device is classified under 21 CFR 870.2450 and serves as a diagnostic aid in procedural and intensive care environments.
This system is intended for use in regulated medical facilities, adhering to FDA 510(k) clearance (K172969). It is supplied as a reusable device, requiring proper maintenance and calibration to ensure accurate display performance. The system is not MRI-safe and must be stored in a controlled environment to preserve functionality. No sterility claims are associated with this device.
Frequently asked questions
What clinical environments is the Essence 55S Large Monitor System primarily designed for, and how does it support real-time patient monitoring?
The Essence 55S is specifically designed for cardiovascular settings, including procedural and intensive care environments. It provides high-resolution visual output to display critical patient data in real-time, enabling clinicians to closely observe vital signs and other diagnostic information during high-stakes interventions or ongoing monitoring.
Is the Essence 55S Large Monitor System intended for single-use or reusable applications, and what maintenance is required?
The Essence 55S is a reusable device, meaning it is not disposable. To ensure accurate performance, it requires proper maintenance and calibration as part of its operational lifecycle. Regular upkeep is essential to sustain display quality and reliability in clinical use.
What storage conditions are necessary to maintain the functionality of the Essence 55S Large Monitor System?
The device must be stored in a controlled environment to preserve its functionality. While no specific temperature or humidity requirements are detailed, proper handling and protection from physical damage are implied to avoid degradation of performance over time.
Does the Essence 55S Large Monitor System have any MRI compatibility, and what safety precautions should be taken?
The Essence 55S is not MRI-safe, meaning it should not be used or stored in an MRI environment. Clinicians must ensure the device remains outside MRI zones to prevent interference or safety risks to patients and staff.
How is the regulatory pathway for the Essence 55S Large Monitor System defined, and what does this mean for purchasers?
The device follows the FDA 510(k) clearance pathway (K172969) under 21 CFR 870.2450, classified as a Class II medical device. This means it has been deemed substantially equivalent to a predicate device and meets FDA requirements for safety and effectiveness. Purchasers should confirm compliance with FDA guidelines and institutional procurement protocols.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Essence 55S Large Monitor System (K172969) — FDA 510(k) | Innolitics, Essence 55S Large Monitor System (K172969) - FDA 510 (k), Essence 55S Large Monitor System — FDA K172969, Essence 55S Large Monitor System (K172969) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172969 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenyang Torch-Bigtide Digital Technology Co., Ltd.
Sources (1)
- FDA 510(k) K172969 24 fields · synced Sep 19, 2026