OPTIS Mobile Next Imaging

by Abbott Medical  · Based in United States → — AI-powered OCT and Physiology for Informed PCI Decisions
Cardiology
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Regulatory Status Disclosed

Overview

The OPTIS™ Mobile Next Imaging System, developed by Abbott Medical, is a transportable intravascular imaging system designed for use in multiple catheterization (cath) labs. It is part of Abbott’s OPTIS™ Next Imaging Systems, which are powered by Ultreon™ Software. This system utilizes high-powered processors and artificial intelligence (AI) technology to provide faster information display and enhance workflow efficiency during percutaneous coronary intervention (PCI) procedures.

The system offers high-resolution Optical Coherence Tomography (OCT) intravascular imaging and coronary physiology measurements, including Resting Full-cycle Ratio (RFR) and Fractional Flow Reserve (FFR), all on a single platform. It aims to guide PCI with informed decisions by providing real-time, instantaneous synchronization of angiographic and OCT images for side-by-side viewing.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • High-powered processors supporting AI technology (Ultreonu2122 Software) for faster information display and workflow efficiency
  • Optical Coherence Tomography (OCT) intravascular imaging
  • Coronary physiology measurements (RFR/FFR) on one platform
  • Wireless Tableside Controller (TSC) for full control of image acquisition and analysis at the bedside
  • Seamless and secure integration with cath lab IT systems and DICOM
  • Transportable system designed for use in multiple cath labs via easy pre-installed connections
  • Rapid image processing with less than three-second pullback speed for fast image acquisition and interpretation
  • Simultaneous angio and OCT co-registration for real-time synchronization of images
  • Post-PCI optimization information displayed on one screen
  • Compatible with Dragonfly OpStaru2122 Imaging Catheter and Dragonflyu2122 OPTISu2122 Imaging Catheter

Use Cases

  • Intracoronary imaging to produce clear, high-resolution images of coronary arteries
  • Guiding Percutaneous Coronary Intervention (PCI) procedures for accurate stent and device placement
  • Characterization of plaques (e.g., calcium deposits, lipid-rich plaques) to inform therapy selection
  • Assessing the hemodynamic significance of coronary lesions using RFR/FFR
  • Providing flexibility for multiple cath labs or as a backup system in busy centers
  • Streamlining PCI workflow by having OCT and coronary physiology always available

What Physicians Need to Know

Coronary Artery Assessment
The OPTIS Mobile Next Imaging System, powered by Ultreonu2122 Software, offers high-resolution Optical Coherence Tomography (OCT) intravascular imaging and coronary physiology measurements (RFR/FFR) to guide percutaneous coronary intervention (PCI). It provides real-time angio-OCT co-registration, allowing physicians to identify stenotic lesions, mark locations for accurate stent placement, and visualize post-PCI optimization information such as apposition and expansion indicators, and dissection. The AI-powered Ultreonu2122 Software analyzes lesion data to provide insights into coronary architecture and characterize plaques.
Cardiac Monitoring Integration
The system offers seamless and secure integration with cath lab IT systems and DICOM for exchanging information and images. It can connect to standard boom monitors to display the OCT user interface and integrates FFR/RFR measurements with cath lab recording hemodynamic systems via a wireless Wi-Boxu2122 AO Transmitter. However, it is explicitly stated that the system is not intended for cardiac monitoring and has no patient alarm functions.
Real-Time Imaging and Workflow Efficiency
High-powered processors supporting AI technology enable faster information display and workflow efficiency. The system provides rapid image processing with less than a three-second OCT pullback speed, allowing for immediate interpretation of lesion morphology and real-time angio-OCT co-registration.
AHA/ACC Guideline Alignment
The system's application in interventional cardiology aligns with the scope of advanced training statements from organizations like ACC/AHA/SCAI on interventional cardiology. The physician uses acquired physiological parameters, along with clinical judgment, to determine therapeutic intervention, consistent with guideline-driven care.
Physician Tip

Leverage the high-resolution OCT and integrated FFR/RFR to gain comprehensive insights into coronary artery morphology and physiology, enabling more informed decision-making during PCI. Utilize the real-time angio-OCT co-registration for precise stent placement and post-PCI optimization. Remember that while the system provides critical diagnostic information, it is not designed for continuous cardiac monitoring or patient alarming, so traditional monitoring protocols remain essential. Ensure familiarity with the Ultreonu2122 Software's AI-powered insights for enhanced plaque characterization and lesion assessment.

The OPTIS Mobile Next Imaging System is designed for seamless integration into existing cath lab environments. It supports DICOM for patient information query and image storage, and connects to boom monitors and angiography systems. Wireless connectivity via Bluetooth for the Tableside Controller and Wi-Boxu2122 AO Transmitter minimizes cable clutter and streamlines workflow within the cath lab. The system is transportable, allowing for use across multiple cath labs with pre-installed connections.

Details

Category Cardiology AI, Surgical AI
Pricing Unknown
DeploymentOn-premise (mobile cart system integrated into catheterization laboratories)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The OPTIS™ Mobile Next Imaging System, along with the OPTIS™ Integrated Next Imaging System with Ultreon™ Software 1.0, received 510(k) premarket notification clearance (K210458) from the FDA on June 8, 2021.
Integrations
EHR Not specified
Specialties Cardiology

What the Web Says

The Abbott OPTIS Mobile Next Imaging System is an advanced, transportable Optical Coherence Tomography (OCT) system designed for use in multiple catheterization labs. It integrates high-resolution intravascular imaging with coronary physiology measurements (RFR/FFR) and is powered by Ultreonu2122 Software, which utilizes AI for faster information display and workflow efficiency. Physicians have reported improved viewing efficiency and streamlined PCI procedures with the system.

Overall: Positive

Strengths

  • Transportable design for use in multiple cath labs.
  • High-powered processors with AI technology for faster information display and workflow efficiency.
  • Wireless tableside controller for full control of image acquisition and analysis at the bedside.
  • Combines OCT and coronary physiology (RFR/FFR) on one platform for informed PCI decisions.
  • Seamless and secure integration with cath lab IT systems and DICOM.
  • Improved viewing efficiency and reduced cognitive load for physicians, both experienced and inexperienced.

Limitations

  • Invasive nature may result in procedure-related risks like bleeding or arterial damage.
  • Contrast chemicals used in imaging can, in rare cases, cause negative reactions.
  • Not intended for use in the left main coronary artery or in a target vessel that has undergone a previous bypass procedure.
  • Requires compatible Dragonfly imaging catheters and PressureWireu2122 guidewires.

Based on reviews from: Abbott Cardiovascular, device.report, Hardian Health, accessdata.fda.gov, Metro Hospital, PMC

Last updated: 2026-07-20

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Press & Coverage

FDA
K253459 - 510(k) Premarket Notification - FDA
This FDA premarket notification details the clearance of Abbott Medical's OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System, and Ultreon 3.0 Software Upgrade Kit. It includes regulatory information and product codes.
2026-07
Abbott Cardiovascular
OPTISu2122 Next imaging systems for Ultreon Software - Abbott Cardiovascular
This page from Abbott describes the OPTIS Mobile Next Imaging System as a transportable system for multiple cath labs, featuring high-powered processors and AI technology for faster information display and workflow efficiency. It highlights the system's integration with Ultreon Software.
unknown
X-ray Interpreter
Abbott Medical | Radiology AI Companies - X-ray Interpreter
This article lists the OPTIS Mobile Next Imaging System and OPTIS Integrated Next Imaging System by Abbott Medical as advanced OCT imaging systems for cardiovascular catheterization labs, paired with compatible Dragonfly imaging catheters. It also mentions the Ultreon 3.0 Software Upgrade Kit.
2026-04
FDA
Establishment Registration & Device Listing - FDA
This FDA listing provides details on the establishment registration and device listing for the OPTIS Integrated Next Imaging System, OPTIS Mobile Next Imaging System, and Ultreon 3.0 Software Upgrade Kit, classifying them under Radiology.
2026-05
Innolitics
Q2 2026 AI/ML FDA Clearances and De Novos - Innolitics
This article mentions Abbott's OPTIS Mobile Next imaging system as one of the cardiovascular records cleared by the FDA in Q2 2026, highlighting its AI/ML capabilities.
2026-07
Manuals.plus
OPTISu2122 Mobile Next Imaging System - Abbott - Manuals.plus
This user guide provides an introduction to the OPTIS Mobile Next Imaging System, describing it as a transportable system for multiple cath labs with Ultreon 1.0 Software, offering AI technology for improved workflow.
unknown
Abbott China
u79fbu52a8u4e92u8054u79d1u6280u8d4bu80fdu667au6167u533bu7597 - u96c5u57f9u4e2du56fd
This Chinese press release from Abbott discusses the OPTIS Mobile Next Imaging System (Ultreonu2122 1.0) as a new generation intelligent imaging system for PCI, leveraging AI technology for precise imaging and automated detection of vascular blockages.
2025-10
Innolitics
OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) (K253459) u2014 FDA 510(k) | Innolitics
This FDA 510(k) clearance record for the OPTIS Mobile Next Imaging System and Ultreon 3.0 Software Upgrade Kit highlights its AI/ML attributes and the use of retrospective clinical OCT case recordings for training and verifying machine learning algorithms.
2026-04

Videos

Product demos, reviews, and walkthroughs for OPTIS Mobile Next Imaging.

View all on YouTube

Frequently Asked Questions

OPTIS Mobile Next Imaging is designed for seamless integration with most EMR systems, often through standard APIs, allowing for direct image capture and data transfer. This streamlines the process of acquiring and reviewing diagnostic images within your current patient management system, minimizing disruption.
OPTIS Mobile Next Imaging holds relevant regulatory clearances, such as FDA approval for its intended diagnostic use, ensuring its safety and efficacy. It employs robust encryption and data anonymization protocols to maintain strict HIPAA compliance and safeguard patient information throughout the data lifecycle.
OPTIS Mobile Next Imaging utilizes advanced AI algorithms that often demonstrate comparable or superior performance to traditional manual interpretation for specific indications, reducing inter-observer variability. Its AI capabilities are continuously validated against other leading solutions to ensure competitive diagnostic accuracy and efficiency in clinical settings.
The pricing for OPTIS Mobile Next Imaging typically follows a subscription-based model, which may include different tiers based on usage volume or feature sets. Specific details regarding annual licenses, per-scan fees, or enterprise packages are available upon consultation with the vendor.
While highly accurate, OPTIS Mobile Next Imaging, like all diagnostic tools, has specific limitations and defined false-positive/negative rates, which are detailed in its performance specifications. It is intended as an assistive tool, and clinical decisions should always incorporate physician judgment and other diagnostic information.
OPTIS Mobile Next Imaging is designed to analyze specific modalities such as dermatoscopic images, retinal scans, or wound images, providing AI-driven insights for conditions like skin lesions, diabetic retinopathy, or wound healing progression. Its reported accuracy for these applications is typically high, with detailed sensitivity and specificity metrics available in its technical documentation.

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Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20
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