Imacor Zura Evo Imaging System
FDA 510(k)Class II (US FDA 510(k))
by Imacor, Inc.
Identifiers
- 510(k) Number
- K142054 FDA 510(k)
- FDA Product Code
- IYO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1560 FDA 510(k)
- Regulation Number
- 892.1560 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Imacor Zura Evo Imaging System is a hemodynamic ultrasound system designed for episodic assessment in the critical care environment. It is the companion device to the ClariTEE transesophageal echocardiography probe, which enables direct visualization of cardiac size and function.
The system is supplied as part of an advanced hemodynamic management platform for at-risk patients. It is intended for use in critical care settings and is authorized under FDA 510K clearance with product code IYO.
Frequently asked questions
What is the Imacor Zura Evo Imaging System designed for?
The Imacor Zura Evo Imaging System is a hemodynamic ultrasound system designed for episodic assessment in the critical care environment, serving as a companion device to the ClariTEE transesophageal echocardiography probe for direct visualization of cardiac size and function.
In what type of setting is the Imacor Zura Evo Imaging System intended to be used?
The system is intended for use in critical care settings as part of an advanced hemodynamic management platform for at-risk patients requiring cardiac assessment.
What is the regulatory status of the Imacor Zura Evo Imaging System?
The Imacor Zura Evo Imaging System is authorized under FDA 510K clearance with product code IYO, having been determined substantially equivalent to predicate devices.
What does the Imacor Zura Evo Imaging System work with?
The system works as a companion device to the ClariTEE transesophageal echocardiography probe, enabling direct visualization of cardiac size and function in critical care patients.
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: Imacor ZURA EVO Manuals | ManualsLib, IMACOR ZURA EVO MANUAL Pdf Download | ManualsLib, EVO 1 - Hemodynamic Ultrasound for ICU | ImaCor, PDF ImaCor_Zura_Manual_v221_v4
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142054 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Imacor, Inc.
Sources (1)
- FDA 510(k) K142054 24 fields · synced Sep 19, 2026