RS85 Diagnostic Ultrasound System

by Samsung Medison Co.  · Based in South Korea → — Premium Ultrasound System with Advanced Intelligence for Diagnostic Confidence.
Endocrinology Gastroenterology Radiology

Not publicly available
Regulatory Status Disclosed

Overview

The Samsung RS85 Diagnostic Ultrasound System is a high-end, versatile ultrasound platform designed to deliver exceptional image quality, advanced diagnostic capabilities, and streamlined workflow for medical professionals. It integrates cutting-edge imaging technologies with AI-enhanced tools to support confident and efficient diagnoses across a wide range of clinical applications.

At its core, the RS85 features Samsung’s innovative Crystal Architecture™, which combines advanced beamforming (CrystalBeam™), sophisticated image processing (CrystalPure™), and high-performance S-Vue Transducers™ to produce clear, uniform, and high-resolution images.

Key diagnostic features include MV-Flow™, an advanced Doppler technology for visualizing slow blood flow in microvascular tissues, and S-Shearwave Imaging™, which quantifies tissue elasticity for improved diagnosis of conditions like liver fibrosis and breast lesions.

The system also incorporates CEUS+ for contrast-enhanced ultrasound imaging to diagnose blood flow issues or characterize lesions, and S-Fusion™, which allows for real-time ultrasound imaging to be coordinated with images from other modalities like MRI and CT for precise lesion localization and biopsy guidance.

For enhanced diagnostic support, the RS85 includes AI-powered tools such as S-Detect™ for Breast and S-Detect™ for Thyroid, which analyze selected lesions and provide standardized reporting to streamline workflow and aid in comprehensive assessment. NerveTrack™ offers AI-powered highlighting to visualize nerves in real-time during interventional procedures. Additionally, QUS (Quantitative Ultrasound) tools like TAI™ (Tissue Attenuation Imaging) and TSI™ (Tissue Scatter Distribution Imaging) provide non-invasive quantitative measurements for assessing steatotic liver changes.

Ergonomically designed, the RS85 aims to reduce user fatigue with features like a 6-way adjustable control panel, a 13.3-inch tilting touchscreen, and customizable interface options for efficient workflow.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Crystal Architectureu2122 (CrystalBeamu2122, CrystalPureu2122, S-Vue Transducersu2122)
  • MV-Flowu2122 (Microvascular Flow Imaging)
  • S-Shearwave Imagingu2122 (Quantitative Tissue Elasticity)
  • CEUS+ (Contrast-Enhanced Ultrasound)
  • S-Fusionu2122 (Real-time Fusion Imaging with CT/MRI)
  • S-Detectu2122 for Breast (AI-powered lesion analysis and reporting)
  • S-Detectu2122 for Thyroid (AI-powered lesion analysis and reporting)
  • NerveTracku2122 (AI-powered nerve visualization)
  • QUS (Quantitative Ultrasound) with TAIu2122 & TSIu2122 for fatty liver assessment
  • ShadowHDRu2122 (Enhanced contrast resolution)

Use Cases

  • General Radiology and Abdominal Imaging
  • Vascular and Cardiology Diagnostics
  • Obstetrics and Gynecology
  • Musculoskeletal (MSK) Imaging
  • Breast and Thyroid Lesion Assessment
  • Interventional Procedures and Biopsy Guidance

Details

Category OB/GYN AI, Oncology AI, Radiology & Imaging AI
Pricing Not publicly available — Contact vendor for quote
DeploymentOn-premise (hardware)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Yes AI-estimated

The Samsung RS85 Diagnostic Ultrasound System has received U.S. Food and Drug Administration (FDA) 510(k) clearance for diagnostic ultrasound imaging and fluid flow analysis.

Integrations
EHR Not specified
Specialties Endocrinology, Gastroenterology, Radiology

What the Web Says

The Samsung RS85 Diagnostic Ultrasound System is a premium ultrasound machine praised by physicians for its exceptional image quality, advanced diagnostic features, and user-friendly design. It aims to provide a new and outstanding experience in diagnosis, offering enriched views, advanced intelligence, and a streamlined workflow.

Overall: Positive

Strengths

  • Spectacular and pleasing image quality, including features like microvascular flow, Lumaflow, and Shadow HDR.
  • User-friendly platform with intuitive navigation and adjustable ergonomics (height, screen tilt, control panel).
  • Enhanced diagnostic confidence through advanced technologies like S-Shearwave Imaging, MV-Flow, and CEUS+.
  • Increased workflow efficiency with features like Quick Preset, EZ-Exam+, QuickScan, and EzCompare.
  • High-frequency probes (e.g., 18 MHz linear probe) allow for detailed imaging of small structures and provide confidence in vascular studies.
  • Advanced intelligence features assist in challenging cases and optimize routine scanning.

Limitations

  • No specific cons were found in the provided search results from physicians, healthcare IT, or tech reviewers.
  • No reviews or opinions were found on Reddit, G2, or Capterra.

Based on reviews from: YouTube (Dr. Jeff Siems, Dr. Ronald Hidalgo, Dr. Steele testimonials), Samsung Medison Official Announcements, ICE Magazine, News-Medical.net, AuntMinnie, DirectMed Imaging, Choice Medical Systems, Inc., USGH Indonesia, Aspen Imaging

Last updated: 2026-07-19

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Press & Coverage

accessdata.fda.gov
RS85 Diagnostic Ultrasound System (K240516)
This regulatory announcement from the FDA details the substantial equivalence determination for the Samsung Medison RS85 Diagnostic Ultrasound System, cleared on June 12, 2024. It outlines the device's intended use for diagnostic ultrasound imaging and fluid flow analysis across various clinical applications.
2024-06
X-ray Interpreter
RS85 Diagnostic Ultrasound System
This product page describes the Samsung Medison RS85 Diagnostic Ultrasound System as a versatile device for various clinical applications, including obstetrics, abdominal, cardiac, musculoskeletal, and peripheral vessel imaging. It highlights multiple imaging modes and the incorporation of AI technology for nerve detection and segmentation.
2024-06
MDPI
Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration in 2024: Regulatory Characteristics, Predicate Lineage, and Transparency Reporting
This peer-reviewed article discusses the regulatory characteristics of AI/ML-enabled medical devices authorized by the FDA in 2024, including the RS85 Diagnostic Ultrasound System (K240516). It notes the RS85's use of deep learning for musculoskeletal ultrasound imaging.
2025-12
accessdata.fda.gov
RS85 Diagnostic Ultrasound System (K221117)
This FDA 510(k) premarket notification from June 17, 2022, details the RS85 Diagnostic Ultrasound System and RS80 EVO Diagnostic Ultrasound System, outlining their general purpose, mobile, software-controlled nature and various imaging modes. It also mentions the addition of new transducers.
2022-06
accessdata.fda.gov
RS85 Diagnostic Ultrasound System (K192903)
An FDA 510(k) clearance from January 6, 2020, for the RS85 Diagnostic Ultrasound System, describing its intended use for diagnostic ultrasound imaging and fluid flow analysis across various clinical applications. It also lists associated transducers.
2020-01
accessdata.fda.gov
RS85 Diagnostic Ultrasound System (K182932)
This FDA 510(k) clearance from June 12, 2019, describes the RS85 Diagnostic Ultrasound System as a general-purpose, mobile, software-controlled device for acquiring and displaying ultrasound data in various modes. It also lists associated transducers.
2019-06
accessgudid.nlm.nih.gov
RS85 Diagnostic Ultrasound System USS-RS85E4S/US GUDID
This GUDID entry provides primary DI and company information for the RS85 Diagnostic Ultrasound System, published on June 17, 2024.
2024-06
ResearchGate
Diagnostic value of cystic artery colour Doppler ultrasound indices in acute cholecystitis | Request PDF
This research paper, published in June 2026, references the 'RS85 diagnostic ultrasound system: user manual' from January 2020 in its methodology for evaluating the diagnostic performance of cystic artery color Doppler ultrasound indices in acute cholecystitis.
2026-06

Videos

Product demos, reviews, and walkthroughs for RS85 Diagnostic Ultrasound System.

View all on YouTube

Frequently Asked Questions

The RS85 integrates AI-driven tools like S-Detectu2122 for breast and thyroid lesions, S-Shearwave Imagingu2122 for tissue stiffness quantification, and NerveTracku2122 for real-time nerve visualization, which aid in diagnostic precision. Additionally, automation features such as QuickScanu2122 and EzExam+u2122 streamline workflows by reducing scan time and repetitive actions.
The Samsung RS85 ultrasound system has received U.S. FDA 510(k) clearance for diagnostic ultrasound imaging and fluid flow analysis. Specific AI features like S-Detectu2122 for Breast and NerveTracku2122 are also noted to be implemented or cleared based on AI technology within Samsung's ultrasound systems.
While specific details for RS85's medical AI were not extensively detailed, Samsung generally states that some AI features process data on-device to ensure privacy, and personal data is not stored long-term or used for AI training. For medical devices, adherence to regulations like HIPAA and GDPR would be paramount, implying robust security protocols for any data processed or transmitted.
The RS85 offers a suite of AI tools such as S-Detectu2122, S-Shearwave Imagingu2122, and NerveTracku2122 for enhanced diagnostics and workflow. Competitors like Philips offer Anatomical Intelligence Ultrasound (AIUS), while GE and Siemens also integrate various AI-powered solutions for image quality, workflow, and specific applications. The distinction often lies in the specific algorithms, applications, and integration within each vendor's ecosystem.
The general pricing for an RS85 system ranges from approximately $19,441 to $41,594. However, the search results do not explicitly detail whether AI features are bundled, subscription-based, or offered as separate modules. This information would typically be obtained through a direct quote from Samsung or an authorized distributor.
General limitations of AI in ultrasound include potential for high variance and bias in image acquisition due to operator skill, patient factors, and artifacts, which can affect algorithm performance. The generalizability of AI algorithms across diverse patient demographics and clinical settings can also be a challenge. While the system provides diagnostic assistance, the ultimate interpretation and decision-making remain with the physician.
Samsung offers ultrasound training classes that cover the RS85 system, including its hardware and software. The user manual also advises familiarity with all areas of the system before use. While specific 'required' training for AI features isn't detailed, comprehensive training would be essential for physicians to understand the capabilities, limitations, and appropriate application of these advanced tools.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
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