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FDA 510(k)

Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers

K-Number: K160442 · 2016-10-21

ApplicantNeural Analytics, Inc.
Decision Date2016-10-21
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers is a medical device manufactured by Neural Analytics, Inc.. It received FDA 510(k) clearance on 2016-10-21 under approval number K160442. 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 Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers?

Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers is a medical device that received FDA 510(k) clearance on 2016-10-21. It is manufactured by Neural Analytics, Inc.. The 510(k) number is K160442.

When was Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers approved by the FDA?

Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers received FDA 510(k) clearance on 2016-10-21, under approval number K160442.

What company makes Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers?

Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers is manufactured by Neural Analytics, Inc..

What is the FDA product code for Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers?

The FDA product code for Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers is IYN.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT07614100 Cerebral Microembolization During Transcatheter Aortic Valve Implantation: Comparing Balloon-expandable and Self-expanding Valves NOT_YET_RECRUITING NCT07099092 Causal Mechanisms of Odor-Guided Behavior in Humans NOT_YET_RECRUITING NCT07613476 Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain ACTIVE_NOT_RECRUITING NCT07613918 Brain Blood Flow and Cerebral Autoregulation Monitoring in Critically Ill Children NOT_YET_RECRUITING NCT06426498 tFUS Induced Transient Scotoma for Individual Dosing RECRUITING

Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by Neural Analytics, Inc.

K180455NeuralBot

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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