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FDA 510(k)

Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

K-Number: K182596 · 2018-11-02

ApplicantCanon Medical Systems Corporation
Decision Date2018-11-02
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2018-11-02 under approval number K182596. 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 Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System?

Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2018-11-02. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K182596.

When was Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System approved by the FDA?

Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System received FDA 510(k) clearance on 2018-11-02, under approval number K182596.

What company makes Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System?

Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System is manufactured by Canon Medical Systems Corporation.

What is the FDA product code for Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System?

The FDA product code for Xario200G and Xario100G, Software V1.1 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 NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT07613476 Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain ACTIVE_NOT_RECRUITING NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT05857852 Low-Intensity Focused Ultrasound for Cocaine Use Disorder COMPLETED

Related PubMed Literature

PMID: 41124399 Integration of an Artificial Intelligence-Based Autism Diagnostic Device into the ECHO Autism Primary Care Workflow: Prospective Observational Study. JMIR formative research (2025) PMID: 38767890 Strengthening the use of artificial intelligence within healthcare delivery organizations: balancing regulatory compliance and patient safety. Journal of the American Medical Informatics Association : JAMIA (2024) PMID: 35047938 Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy. Frontiers in medical technology (2021) PMID: 37181834 Methodology for Conducting Post-Marketing Surveillance of Software as a Medical Device Based on Artificial Intelligence Technologies. Sovremennye tekhnologii v meditsine (2022)

Other Devices by Canon Medical Systems Corporation

K182601Vitrea Software Package, VSTP-001A K183013Vitrea Software Package, VSTP-001A K181646Celesteion, PCA-9000A/3, V6.5 K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1 K182282Vantage Orian 1.5T, MRT-1550, V4.5

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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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