HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System

Samsung Medison Co., Ltd. • Radiology • 10/11/2024

510(k)IEC 62304 Class B

Device Purpose

The Samsung Medison HERA Z20, R20, Z30, R30 Diagnostic Ultrasound System is a general-purpose, mobile, software-controlled device designed for comprehensive ultrasound imaging and body fluid analysis across various clinical applications. It leverages multiple operational modes and AI-powered features to enhance diagnostic capabilities and workflow efficiency, with its safety and effectiveness confirmed through rigorous non-clinical testing against established performance standards.

Summary

Samsung Medison Co., Ltd. has developed the HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System, which has been determined substantially equivalent to existing marketed devices. This system is a versatile, mobile, and software-controlled ultrasound device capable of obtaining images and analyzing body fluids. It is designed for use by trained healthcare professionals across diverse clinical settings, including hospitals and private practices, for a broad range of applications such as Fetal/Obstetrics, Abdominal, Gynecology, Cardiac, and Vascular imaging.The system supports multiple operational modes, including 2D, M-mode, various Doppler modes (Color, Pulsed Wave, Continuous Wave, Tissue Doppler), Power Doppler, ElastoScan, MV-Flow, Multi-Image, and 3D/4D capabilities. It incorporates advanced features like AI-powered BiometryAssist, HeartAssist, and ViewAssist to improve image analysis and streamline workflow, alongside specialized tools for volume measurement (EzVolume) and uterine contouring (UterineContour). Comprehensive non-clinical testing, covering acoustic output, biocompatibility, software function, cleaning, disinfection, and electrical/mechanical safety, confirmed the device's compliance with applicable safety and performance standards, thereby ensuring its safety and effectiveness for its intended uses.

AI Regulatory Concerns

Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

Keywords

Diagnostic Ultrasound SystemHERA Z20/R20/Z30/R30AI-poweredMobile deviceGeneral-purposeFetal/Obstetrics imagingMulti-mode operationBiometryAssistClinical applicationsSafety standards

Device Metadata

Submission Number

K241971

Company

Samsung Medison Co., Ltd.

Panel

Radiology

Product Code

N/A

Data Type

N/A

Clinical Function

N/A

AI Function

N/A

AI Subclass

N/A

Relevant Clinical Questions

Q1. How do the AI-powered features (BiometryAssist, HeartAssist, ViewAssist) specifically enhance diagnostic accuracy and workflow efficiency compared to traditional ultrasound methods?; What are the specific clinical advantages or limitations of the HERA Z20/R20/Z30/R30 systems in specialized applications like high-risk obstetric or complex cardiac imaging?; Are there any published clinical studies or post-market surveillance data demonstrating the real-world performance, reliability, and reproducibility of measurements obtained using advanced features such as EzVolume and UterineContour?; How does the system's software architecture support future upgrades or integration of emerging diagnostic algorithms and new imaging modalities?; What training and support are provided to ensure appropriate and effective utilization of the system's advanced features by healthcare professionals across various clinical environments?

Risk Classification

ESL Analysis

IEC 62304 ClassB

FDA Device ClassII

FDA Class II via 510(k) pathway; IEC 62304 Class B (software safety classification); Post-§524B but no clear network capability detected

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Cybersecurity Evidence

Based on AI-generated device summaries, not the full FDA submission. Items not detected here may still be present in the complete submission package.

Cyber Score25/100

SBOM Evidence⚠ Not in summary - likely in full submission per §524B

Cyber Risk Assessment⚠ Not in summary - likely in full submission per §524B

Postmarket Plan✓ Detected in Summary

§524B ApplicableYes

Supply Chain BOM Evidence

Based on the CycloneDX / OWASP ECMA-424 xBOM ecosystem. Detection is from the AI-generated summary.

SBOMSoftware Bill of Materials

- Not detected

ML-BOMMachine Learning Bill of Materials(algorithm)

✓ Detected

SaaSBOMSoftware-as-a-Service Bill of Materials

- Not detected

HBOMHardware Bill of Materials

- Not detected

CBOMCryptography Bill of Materials

- Not detected

VDR/VEXVulnerability Disclosure Report / Vulnerability Exploitability eXchange

- Not detected

OBOMOperations Bill of Materials(environment, operational)

✓ Detected

Analysis:

• Analysis is based on the AI-generated device summary, not the full FDA submission package. Click "Analyze Full FDA PDF" below to scan the actual submission document.

• Evidence of ML-BOM, OBOM detected in AI-generated device summary.

• SBOM not mentioned in AI-generated device summary. Under §524B (effective Oct 2023), cyber devices must provide a SBOM.

• Cybersecurity risk assessment not referenced in AI-generated device summary. FDA cybersecurity guidance (2023) expects this for cyber devices.

• Not detected in AI-generated device summary: SBOM, SaaSBOM, HBOM, CBOM, VDR/VEX. These may be present in the full FDA submission.

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