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FDA 510(k)

HERA I10 Diagnostic Ultrasound System

K-Number: K190444 · 2019-05-22

ApplicantSamsung Medison Co., Ltd.
Decision Date2019-05-22
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HERA I10 Diagnostic Ultrasound System is a medical device manufactured by Samsung Medison Co., Ltd.. It received FDA 510(k) clearance on 2019-05-22 under approval number K190444. 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 I10 Diagnostic Ultrasound System?

HERA I10 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2019-05-22. It is manufactured by Samsung Medison Co., Ltd.. The 510(k) number is K190444.

When was HERA I10 Diagnostic Ultrasound System approved by the FDA?

HERA I10 Diagnostic Ultrasound System received FDA 510(k) clearance on 2019-05-22, under approval number K190444.

What company makes HERA I10 Diagnostic Ultrasound System?

HERA I10 Diagnostic Ultrasound System is manufactured by Samsung Medison Co., Ltd..

What is the FDA product code for HERA I10 Diagnostic Ultrasound System?

The FDA product code for HERA I10 Diagnostic Ultrasound System is IYN.

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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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