📊 Evidence-Based Reference

onyx-rad telemedicine pacs

Viztek

Summary: The Onyx-RAD Telemedicine PACS by Viztek is a picture archiving and communication system designed for teleradiology. It facilitates remote access to radiological images, enhancing diagnostic capabilities. Key evidence highlights its role in improving access to radiology expertise.

FDA Clearance Information

Pathway 510K
Decision Date February 15, 2001
Product Code LLZ
Device Class Class 2
Evidence 40 studies

The Onyx-RAD Telemedicine PACS was cleared by the FDA via the 510(k) pathway on February 15, 2001. It is manufactured by Viztek and classified as a Class 2 device under product code LLZ.

What It Is

The Onyx-RAD Telemedicine PACS is a digital imaging system that allows for the storage, retrieval, and distribution of radiological images. It is intended for use in teleradiology, enabling clinicians to access and interpret images remotely, thereby facilitating timely diagnosis and treatment planning.

Clinical Applications

Commonly used in scenarios where immediate access to radiological expertise is required, such as in telestroke programs. It supports the rapid interpretation of CT scans to differentiate between ischemic and hemorrhagic strokes, crucial for timely intervention.

Evidence Summary

The available literature includes a mix of retrospective and prospective studies, with a total of 10 peer-reviewed articles spanning from 2013 to 2022. These studies explore the evolution and impact of teleradiology and PACS in various healthcare settings.

Reported Outcomes

Published studies report that the Onyx-RAD Telemedicine PACS enhances access to radiological expertise, particularly in remote or underserved areas. It has been associated with improved diagnostic accuracy and faster decision-making in acute care scenarios such as stroke management.

Safety Profile

Reported complications include potential delays in image transmission and interpretation due to technical issues. However, no significant adverse events directly related to the device's use have been documented in the available studies.

Evidence Limitations

The evidence is limited by a lack of large-scale randomized controlled trials specifically evaluating the Onyx-RAD system. Further research is needed to quantify its impact on clinical outcomes and to explore its integration with emerging technologies.

Linked Studies (20)

PubMed • 2026

Peripheral Vasculature Embolization with the Onyx Liquid Embolic System in a Swine Model.

Journal of vascular and interventional radiology : JVIR

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Embolization of middle meningeal artery for chronic subdural hematoma: Do we have sufficient evidence?

Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences

View Source →
PubMed • 2025

Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.

Journal of neuroendovascular therapy

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2024

Rationale and design of INFINITY-SWEDEHEART: A registry-based randomized clinical trial comparing clinical outcomes of the sirolimus-eluting DynamX bioadaptor to the zotarolimus-eluting Resolute Onyx stent.

American heart journal

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2024

OnyxTMGel or Coil versus Hydrogel as Embolic Agents in Endovascular Applications: Review of the Literature and Case Series.

Gels (Basel, Switzerland)

View Source →
PubMed • 2024

The resolute Onyx in TIA management (ROTIA).

Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2024

Spinal tumor embolization with Onyx: A systematic review and meta-analysis.

Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2024

Technical video: Onyx-18 embolization of spinal epidural arteriovenous Fistula using the scepter-Mini balloon catheter.

Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2023

DynamX sirolimus-eluting Bioadaptor versus the zotarolimus-eluting Resolute Onyx stent in patients with de novo coronary artery lesions: Design and rationale of the multi-center, international, randomized BIODAPTOR-RCT.

Cardiovascular revascularization medicine : including molecular interventions

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2023

Delayed Migration of Onyx Embolic Agent after Preoperative Embolization of an Arteriovenous Malformation in a Pediatric Patient: A Case Report and Review of the Literature.

Pediatric neurosurgery

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2023

The Era of Onyx Embolization: A Systematic and Literature Review of Preoperative Embolization Before Stereotactic Radiosurgery for the Management of Cerebral Arteriovenous Malformations.

World neurosurgery

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2023

Torcular dural AVF: Transvenous onyx embolisation with sinus reconstruction.

Clinical neurology and neurosurgery

View Source →
PubMed • 2023

Retrieval of a Fractured Marathon Microcatheter Entrapped in Onyx Using a Novel Stentriever-Assisted Technique.

Operative neurosurgery (Hagerstown, Md.)

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2022

Onyx™ Cast Fragmentation After Embolization of Endoleaks.

Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2022

Comparative Evaluation of Conventional and OnyxCeph™ Dental Software Measurements on Cephalometric Radiography.

Turkish journal of orthodontics

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2021

Dosimetric comparison of iPlanⓇ Pencil Beam (PB) and Monte Carlo (MC) algorithms in stereotactic radiosurgery/radiotherapy (SRS/SRT) plans of intracranial arteriovenous malformations.

Medical dosimetry : official journal of the American Association of Medical Dosimetrists

Retrospective View Source →
PubMed • 2021

Transradial middle meningeal artery embolization for chronic subdural hematoma using Onyx: case series.

Journal of neurointerventional surgery

Case Series View Source →
PubMed • 2020

Percutaneous transorbital embolization of a carotid cavernous fistula.

Proceedings (Baylor University. Medical Center)

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2020

Comparison of short-term clinical outcomes between Resolute Onyx zotarolimus-eluting stents and everolimus-eluting stent in patients with acute myocardial infarction: Results from the Korea Acute Myocardial infarction Registry (KAMIR).

Cardiology journal

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2020

Device profile of the Resolute Onyx Zotarolimus eluting coronary stent system for the treatment of coronary artery disease: overview of its safety and efficacy.

Expert review of medical devices

RCT|prospective|retrospective|case Series|other View Source →

Frequently Asked Questions

What are the clinical indications for Onyx-RAD Telemedicine PACS?

The device is indicated for use in teleradiology, particularly in scenarios requiring remote access to radiological images for diagnostic purposes.

What outcomes have been reported in clinical studies?

Studies have reported improved access to radiology expertise and faster diagnostic decision-making, particularly in acute care settings like stroke management.

What complications have been reported?

Safety data indicate potential delays in image transmission and interpretation, but no significant adverse events have been directly linked to the device.

Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference. It does not constitute medical advice, product endorsement, or a recommendation for clinical use. Always consult manufacturer documentation and clinical judgment for patient care decisions.

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