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FDA 510(k)

HS50 / HS60 Diagnostic Ultrasound System

K-Number: K181336 · 2018-12-04

ApplicantSamsung Medison Co., Ltd.
Decision Date2018-12-04
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HS50 / HS60 Diagnostic Ultrasound System is a medical device manufactured by Samsung Medison Co., Ltd.. It received FDA 510(k) clearance on 2018-12-04 under approval number K181336. 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 HS50 / HS60 Diagnostic Ultrasound System?

HS50 / HS60 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2018-12-04. It is manufactured by Samsung Medison Co., Ltd.. The 510(k) number is K181336.

When was HS50 / HS60 Diagnostic Ultrasound System approved by the FDA?

HS50 / HS60 Diagnostic Ultrasound System received FDA 510(k) clearance on 2018-12-04, under approval number K181336.

What company makes HS50 / HS60 Diagnostic Ultrasound System?

HS50 / HS60 Diagnostic Ultrasound System is manufactured by Samsung Medison Co., Ltd..

What is the FDA product code for HS50 / HS60 Diagnostic Ultrasound System?

The FDA product code for HS50 / HS60 Diagnostic Ultrasound System is IYN.

Related Clinical Trials

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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.

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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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