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FDA 510(k)

HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System

K-Number: K230084 · 2023-04-21

ApplicantSamsung Medison Co., Ltd.
Decision Date2023-04-21
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System is a medical device manufactured by Samsung Medison Co., Ltd.. It received FDA 510(k) clearance on 2023-04-21 under approval number K230084. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System?

HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2023-04-21. It is manufactured by Samsung Medison Co., Ltd.. The 510(k) number is K230084.

When was HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System approved by the FDA?

HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System received FDA 510(k) clearance on 2023-04-21, under approval number K230084.

What company makes HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System?

HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System is manufactured by Samsung Medison Co., Ltd..

What is the FDA product code for HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System?

The FDA product code for HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System is IYN.

Related Clinical Trials

NCT07040696 Accuracy of Venous Excess Ultrasound Score at Hospital Admission to Predict Acute Kidney Injury COMPLETED NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT07613476 Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain ACTIVE_NOT_RECRUITING NCT05857852 Low-Intensity Focused Ultrasound for Cocaine Use Disorder COMPLETED NCT04981223 Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging COMPLETED NCT07608614 Sleep and Performance RECRUITING

Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025) PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025)

Other Devices by Samsung Medison Co., Ltd.

K153539RS80A Diagnostic Ultrasound System K162094RS80A Diagnostic Ultrasound System K1619555D Viewer K153529WS80A Diagnostic Ultrasound System K171048RS80A Diagnostic Ultrasound System K171070WS80A Diagnostic Ultrasound System

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Related Devices (Code: IYN)

K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi , Ltd. K163138Clarius Ultrasound SystemClarius Mobile Health Corp. K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics K162583ALOKA LISENDO 880Hitachi , Ltd. K163020Xperius Ultrasound SystemPhilips Health Care

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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