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FDA 510(k)

ACUSON Freestyle Diagnostic Ultrasound System

K-Number: K200644 · 2020-04-10

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2020-04-10
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACUSON Freestyle Diagnostic Ultrasound System is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2020-04-10 under approval number K200644. 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 Diagnostic Ultrasound System?

ACUSON Freestyle Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2020-04-10. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K200644.

When was ACUSON Freestyle Diagnostic Ultrasound System approved by the FDA?

ACUSON Freestyle Diagnostic Ultrasound System received FDA 510(k) clearance on 2020-04-10, under approval number K200644.

What company makes ACUSON Freestyle Diagnostic Ultrasound System?

ACUSON Freestyle Diagnostic Ultrasound System is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for ACUSON Freestyle Diagnostic Ultrasound System?

The FDA product code for ACUSON Freestyle Diagnostic Ultrasound System is IYN.

Related Clinical Trials

NCT07040696 Accuracy of Venous Excess Ultrasound Score at Hospital Admission to Predict Acute Kidney Injury COMPLETED NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT07613476 Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain ACTIVE_NOT_RECRUITING NCT05754281 The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System ACTIVE_NOT_RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT05857852 Low-Intensity Focused Ultrasound for Cocaine Use Disorder COMPLETED

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)

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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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