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FDA 510(k)

Acclarix AX8 Diagnostic Ultrasound System

K-Number: K161300 · 2016-05-31

ApplicantEdan Instruments, Inc.
Decision Date2016-05-31
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Acclarix AX8 Diagnostic Ultrasound System is a medical device manufactured by Edan Instruments, Inc.. It received FDA 510(k) clearance on 2016-05-31 under approval number K161300. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Acclarix AX8 Diagnostic Ultrasound System?

Acclarix AX8 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-05-31. It is manufactured by Edan Instruments, Inc.. The 510(k) number is K161300.

When was Acclarix AX8 Diagnostic Ultrasound System approved by the FDA?

Acclarix AX8 Diagnostic Ultrasound System received FDA 510(k) clearance on 2016-05-31, under approval number K161300.

What company makes Acclarix AX8 Diagnostic Ultrasound System?

Acclarix AX8 Diagnostic Ultrasound System is manufactured by Edan Instruments, Inc..

What is the FDA product code for Acclarix AX8 Diagnostic Ultrasound System?

The FDA product code for Acclarix AX8 Diagnostic Ultrasound System is IYO.

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 NCT05857852 Low-Intensity Focused Ultrasound for Cocaine Use Disorder COMPLETED NCT04981223 Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging COMPLETED NCT07608614 Sleep and Performance RECRUITING

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)

Other Devices by Edan Instruments, Inc.

K160981Patient Monitor K151978EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control K161302PC ECG K152552Patient Monitor K160790Acclarix LX8 Diagnostic Ultrasound System K152427PC ECG

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Related Devices (Code: IYO)

K162972ExactVu High Resolution Micro-Ultrasound SystemExact Imaging K161968MicrUsTelemed K161342Sonic WindowAnalogic Corporation K153620Enovare Ultrasound SystemOreon Technologies, Inc. K160792Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder UltrasoundThe Prometheus Group K153581Bladder ScannerCaresono Technology Co., Ltd.

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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