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FDA 510(k)

Acuson Freestyle Ultrasound System

K-Number: K162417 · 2016-09-28

ApplicantSiemens Medi Cal Solutions, Inc.
Decision Date2016-09-28
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Acuson Freestyle Ultrasound System is a medical device manufactured by Siemens Medi Cal Solutions, Inc.. It received FDA 510(k) clearance on 2016-09-28 under approval number K162417. 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 Acuson Freestyle Ultrasound System?

Acuson Freestyle Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-09-28. It is manufactured by Siemens Medi Cal Solutions, Inc.. The 510(k) number is K162417.

When was Acuson Freestyle Ultrasound System approved by the FDA?

Acuson Freestyle Ultrasound System received FDA 510(k) clearance on 2016-09-28, under approval number K162417.

What company makes Acuson Freestyle Ultrasound System?

Acuson Freestyle Ultrasound System is manufactured by Siemens Medi Cal Solutions, Inc..

What is the FDA product code for Acuson Freestyle Ultrasound System?

The FDA product code for Acuson Freestyle Ultrasound System is IYN.

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Other Devices by Siemens Medi Cal Solutions, Inc.

K162102MAGNETOM Avantofit, MAGNETOM Skyrafit K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System K153360ADMIRE K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit K171766Acuson SC2000 Diagnostic Ultrasound System K170315Acuson SC2000 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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