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FDA 510(k)

Ultrasound System SONIMAGE HS1

K-Number: K162065 · 2016-10-19

ApplicantKonica Minolta, Inc.
Decision Date2016-10-19
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ultrasound System SONIMAGE HS1 is a medical device manufactured by Konica Minolta, Inc.. It received FDA 510(k) clearance on 2016-10-19 under approval number K162065. 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 Ultrasound System SONIMAGE HS1?

Ultrasound System SONIMAGE HS1 is a medical device that received FDA 510(k) clearance on 2016-10-19. It is manufactured by Konica Minolta, Inc.. The 510(k) number is K162065.

When was Ultrasound System SONIMAGE HS1 approved by the FDA?

Ultrasound System SONIMAGE HS1 received FDA 510(k) clearance on 2016-10-19, under approval number K162065.

What company makes Ultrasound System SONIMAGE HS1?

Ultrasound System SONIMAGE HS1 is manufactured by Konica Minolta, Inc..

What is the FDA product code for Ultrasound System SONIMAGE HS1?

The FDA product code for Ultrasound System SONIMAGE HS1 is IYN.

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Other Devices by Konica Minolta, Inc.

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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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