Clarify DL

by GE Medical Systems Israel  · Based in Israel → — Enhancing bone SPECT image quality with AI-powered deep learning.
Nuclear Medicine Radiology
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Regulatory Status Disclosed

Overview

Clarify DL is an advanced software-only device developed by GE Medical Systems Israel, a part of GE HealthCare, designed for the reconstruction of Nuclear Medicine (NM) bone Single Photon Emission Computed Tomography (SPECT) and SPECT/CT images. Leveraging deep learning technology, a subset of artificial intelligence, Clarify DL aims to significantly reduce image noise while maintaining or improving contrast and resolution. This results in enhanced image quality, which is crucial for increasing diagnostic confidence in various clinical applications.

The AI-powered solution is integrated into supported GE HealthCare SPECT and SPECT/CT systems, such as the Aurora nuclear medicine system, StarGuide SPECT/CT system, and Xeleris V Processing and Review System. Clinical evaluations have demonstrated that Clarify DL’s image resolution was rated as superior in a high percentage of exams, transforming nuclear medicine bone SPECT imaging diagnostics. Unlike traditional noise reduction techniques that may compromise image contrast and resolution, Clarify DL optimizes reconstruction to deliver clear, accurate, and effortless imaging.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Deep learning image reconstruction
  • Noise reduction in bone SPECT images
  • Enhanced image quality (resolution, contrast, signal-to-noise ratio)
  • Compatible with GE HealthCare SPECT/CT systems (e.g., Aurora, StarGuide, Xeleris V)
  • Supports bone SPECT imaging diagnostics
  • AI-powered image processing
  • Maintains image contrast and resolution during noise reduction

Use Cases

  • Improving diagnostic confidence in nuclear medicine bone SPECT imaging
  • Enhancing image clarity for oncology applications
  • Supporting diagnostic capabilities in cardiology
  • Aiding in neurological imaging evaluations
  • Streamlining clinical workflows in nuclear medicine departments

What Physicians Need to Know

DICOM Support & Standards
As an integral part of GE HealthCare's imaging solutions, Clarify DL operates within a DICOM-compliant environment, facilitating seamless communication, exchange, and interpretation of medical images and data.
PACS Integration Method
Clarify DL is deployed within the software of supported GE HealthCare SPECT and SPECT/CT systems, specifically the Xeleris V Processing and Review System and StarGuide devices. It is designed to seamlessly integrate into existing clinical settings without disrupting workflows.
Reading Room Workflow Impact
The AI-powered solution enhances bone SPECT image quality, aiming to deliver clear, accurate, and effortless imaging. This can lead to increased diagnostic confidence and potentially faster reads, as clinical evaluations showed improved image resolution in 98% of exams. It optimizes reconstruction without sacrificing image quality, unlike traditional noise reduction techniques.
AI Model Architecture (deep learning approach)
Clarify DL utilizes a deep learning-based image reconstruction algorithm. Its model was trained using a 3D residual U-Net convolutional encoder-decoder network in supervised learning sessions, designed to reduce noise in NM bone SPECT scintigraphy images. It leverages a dedicated Deep Neural Network (DNN).
FDA Clearance Pathway (510k/De Novo)
Clarify DL received 510(k) clearance from the U.S. Food and Drug Administration (FDA) on May 5, 2025.
Supported Modalities (CT/MRI/X-ray/US)
Clarify DL is specifically designed for Nuclear Medicine (NM) bone SPECT scintigraphy images obtained using GE HealthCare SPECT and SPECT/CT systems. It is available on Xeleris V and StarGuide systems.
Sensitivity & Specificity Data
Clarify DL improves image quality performance, measured by Structures Similarity (SSIM) up to 8%, Mean Squared Error (MSE) up to 76%, and Peak Signal-to-Noise Ratio (PSNR) up to 18%. It also enhances Contrast-to-Noise Ratio (CNR) and Contrast Recovery Coefficient (CRC). Clinical evaluations demonstrated superior image resolution in 98% of exams.
RSNA/ACR Validation
Clarify DL was unveiled at RSNA 2024. Clinical testing included a reader evaluation of clinical bone SPECT and SPECT/CT exams by certified Nuclear Medicine physicians, who showed a preference for Clarify DL images in terms of overall image quality, resolution, and noise level.
Physician Tip

Clarify DL offers significantly improved bone SPECT image quality, potentially leading to increased diagnostic confidence and more efficient reads. The deep learning reconstruction reduces noise while preserving contrast, which can be particularly beneficial for detecting subtle findings. Its integration into existing GE HealthCare SPECT/CT systems means a familiar workflow with enhanced image output. Consider its use for challenging bone SPECT studies where noise reduction and improved resolution are critical for accurate interpretation.

Clarify DL is a software-only solution deployed directly within GE HealthCare's Xeleris V Processing and Review System and StarGuide SPECT/CT devices. This tight integration ensures compatibility and optimized performance with these specific GE HealthCare modalities. While direct PACS integration details for Clarify DL itself are not extensively detailed, its operation within GE's imaging ecosystem implies standard DICOM communication for image archiving and retrieval, aligning with broader GE HealthCare enterprise imaging strategies.

Details

Category Radiology & Imaging AI
Pricing Contact vendor for pricing.
DeploymentSoftware-only device, deployed within the software of supported GE HealthCare SPECT and SPECT-CT systems.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Clarify DL received U.S. FDA 510(k) clearance (K241350) on January 3, 2025, as a software-only device intended to reduce noise and improve image quality of Nuclear Medicine bone SPECT scintigraphy images.
Integrations
EHR Not specified
Specialties Nuclear Medicine, Radiology

What the Web Says

Clarify DL is a deep learning image reconstruction algorithm developed by GE HealthCare for bone SPECT and SPECT/CT scans. It is designed to enhance image quality by reducing noise, improving resolution, and maintaining contrast, ultimately aiming to increase diagnostic confidence for physicians. The software has received 510(k) clearance from the U.S. FDA and is integrated into GE HealthCare's Xeleris V Processing and Review System and StarGuide SPECT/CT systems.

Overall: Positive

Strengths

  • Improved overall image quality, resolution, and noise levels in bone SPECT scans.
  • Enhances diagnostic confidence for clinicians.
  • Reduces image noise while maintaining contrast and quantitative accuracy.
  • Potential to shorten scan and reading times.
  • Leverages advanced deep learning technology for clear, accurate, and effortless imaging.
  • Can be integrated into existing GE HealthCare SPECT/CT systems.

Limitations

  • Not available for sale in all regions (e.g., previously not in the U.S. and Canada before FDA clearance).
  • User modification of some parameters (e.g., number of iterations and subsets) is not possible, as they are fixed.
  • Limited independent reviews from sources like G2, Capterra, or general tech reviewers were found.
  • Reddit discussions found were not related to the medical device.

Based on reviews from: GE Healthcare, Medical Device Network, FDA, The Health AI Brief, X-ray Interpreter, Abdalla (Artificial intelligence across the cardiovascular diagnostic pathway: a case-based narrative review)

Last updated: 2026-07-18

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Press & Coverage

GE HealthCare
GE HealthCare Introduces Deep Learning Imaging Solutions to Enhance Diagnostics
GE HealthCare unveiled three new deep learning image processing and reconstruction solutions, including Clarify DL, at RSNA 2024, aiming to improve image quality, reduce scan times, and support better patient outcomes. Clarify DL is designed to enhance bone SPECT image quality, an important factor in increasing diagnostic confidence.
2024-12
GE HealthCare
GE HealthCare announces FDA 510(k) clearance for Aurora, a new dual-head SPECT/CT system, and Clarify DL, its AI-powered Deep Learning image reconstruction technology
GE HealthCare received FDA 510(k) clearance for its Aurora nuclear medicine system and Clarify DL, an AI-powered deep learning image reconstruction technology designed to enhance diagnostic capabilities and streamline workflows. Clarify DL improves bone SPECT image quality without increasing injected dose or scan time.
2025-05
Imaging Technology News (ITN)
GE HealthCare Unveils New SPECT/CT, AI-Powered SPECT Image Reconstruction
At RSNA 2024, GE HealthCare introduced Aurora, a new dual-head SPECT/CT, and Clarify DL, a deep learning image reconstruction solution for bone SPECT. Clarify DL was rated as better in 98% of clinical evaluations for image resolution.
2024-12
GE HealthCare
GE HealthCare highlights new solutions including AI-enabled innovations to drive precision care at RSNA 2024
GE HealthCare showcased over 40 innovations at RSNA 2024, including Clarify DL, a bone image reconstruction algorithm powered by AI, which was 510(k) pending in the U.S. at the time. These innovations aim to optimize patient care and increase operational efficiencies.
2024-12
GE HealthCare
GE HealthCare showcases Aurora, a new dual head SPECT/CT, and Clarify DL at #RSNA24
GE HealthCare unveiled Aurora, a new dual-head SPECT/CT, and Clarify DL at RSNA 2024. Clarify DL is a deep learning image reconstruction solution designed to enhance bone SPECT image quality, with clinical evaluations showing improved image resolution in 98% of exams.
2024-12
Medtech Insight
FDA OKs GE HealthCare's Nuclear Medicine System, AI Image Reconstruction
GE HealthCare received FDA 510(k) clearance for its Aurora dual-head SPECT/CT system and Clarify DL imaging technology. Clarify DL uses deep learning to enhance bone SPECT image quality, with clinical evaluations showing better image resolution in 98% of exams.
2025-05
accessdata.fda.gov
GE Medical Systems Israel, Functional Imaging Maysana Mousa Elias Senior Regulatory Affairs Leader GE Health
This FDA document details the 510(k) clearance for Clarify DL, a software-only device for the reconstruction of NM bone SPECT scintigraphy images. Clarify DL is designed to reduce image noise while maintaining contrast, and it includes a Predetermined Change Control Plan for future modifications.
2025-01
ResearchGate
Image Quality Comparison of Clarify DL and Q.Clear Reconstructions for Bone SPECT Scans on a GE StarGuide Gamma Camera.
A study compared GE HealthCare's Clarify DL with Q.Clear for bone SPECT image quality, finding that Clarify DL improved perceived sharpness and contrast for the majority of readers without compromising diagnostic confidence. The study was presented at the BNMS Annual Spring Conference 2026.
2026-07

Videos

Product demos, reviews, and walkthroughs for Clarify DL.

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Frequently Asked Questions

Clarify Health's AI-powered platforms, such as Clarify Atlas and Meridian, integrate by providing actionable insights from extensive patient data to optimize clinical workflows, guide care journeys, and improve network performance. For imaging, GE HealthCare's Clarify DL specifically enhances bone SPECT image quality, which aids in increasing diagnostic confidence. Both applications aim to streamline processes and support more informed decision-making for physicians.
Clarify DL solutions, like other healthcare AI, must adhere to stringent regulations such as HIPAA to protect sensitive patient data. These AI tools are designed to automate compliance checks, monitor for regulatory updates, and verify provider credentials, often incorporating robust encryption, access controls, and audit trails. Physicians, however, retain the professional responsibility to review AI-generated records to ensure accuracy and proper management of patient information.
Deep learning models, including Clarify DL, can present limitations such as their 'black-box' nature, which can make it challenging to understand how specific conclusions or recommendations are derived. They also heavily rely on large quantities of high-quality, unbiased data, and insufficient or biased data can lead to model bias and limit generalizability. Over-reliance on AI without critical physician oversight can also potentially lead to misdiagnosis or a degradation of clinical skills.
For clinical decision support and analytics, alternatives include platforms like Health Catalyst, Glass Health, Dr. Oracle, and Vera Health, as well as traditional reference-based clinical decision support systems such as UpToDate or ClinicalKey AI. In the realm of imaging reconstruction, other deep learning solutions from various vendors are available, alongside conventional image reconstruction methods.
Pricing for healthcare AI solutions like Clarify DL can vary significantly, often involving recurring licensing fees, integration costs with existing Electronic Health Record (EHR) or Electronic Medical Record (EMR) systems, and expenses related to data preparation and compliance. Costs can range from monthly per-provider fees for smaller practices to custom enterprise-level pricing tailored for large health systems. Factors such as the complexity of the solution, infrastructure (cloud vs. on-premises), and the depth of integration required all influence the total investment.
Physicians must be acutely aware of the potential for algorithmic bias within AI systems, making reasonable efforts to identify and address such biases to ensure equitable patient care. Maintaining patient autonomy necessitates transparent communication about AI's role in clinical decisions and securing informed consent. Ultimately, physicians remain professionally and ethically responsible for all diagnostic and treatment decisions, regardless of AI assistance.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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