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FDA 510(k)

HS50/HS60 Diagnostics Ultrasound System

K-Number: K192505 · 2019-12-12

ApplicantSamsung Medison Co., Ltd.
Decision Date2019-12-12
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HS50/HS60 Diagnostics Ultrasound System is a medical device manufactured by Samsung Medison Co., Ltd.. It received FDA 510(k) clearance on 2019-12-12 under approval number K192505. 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 Diagnostics Ultrasound System?

HS50/HS60 Diagnostics Ultrasound System is a medical device that received FDA 510(k) clearance on 2019-12-12. It is manufactured by Samsung Medison Co., Ltd.. The 510(k) number is K192505.

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

HS50/HS60 Diagnostics Ultrasound System received FDA 510(k) clearance on 2019-12-12, under approval number K192505.

What company makes HS50/HS60 Diagnostics Ultrasound System?

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

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

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

Related Clinical Trials

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Related PubMed Literature

PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (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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