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FDA 510(k)

Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System

K-Number: K233195 · 2024-01-24

ApplicantCanon Medical Systems Corporation
Decision Date2024-01-24
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2024-01-24 under approval number K233195. 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 Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System?

Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2024-01-24. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K233195.

When was Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System approved by the FDA?

Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System received FDA 510(k) clearance on 2024-01-24, under approval number K233195.

What company makes Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System?

Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System is manufactured by Canon Medical Systems Corporation.

What is the FDA product code for Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System?

The FDA product code for Aplio i900, Aplio i800 and Aplio i700 Software V8.1 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: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) 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: 41513582 Medical devices for professional use: What assessment, what funding? Therapie (2026) PMID: 40845310 Should Digital Interventions for HIV Self-Testing Be Regulated with World Health Organization Prequalification? JMIR mHealth and uHealth (2025)

Other Devices by Canon Medical Systems Corporation

K182601Vitrea Software Package, VSTP-001A K183013Vitrea Software Package, VSTP-001A K181646Celesteion, PCA-9000A/3, V6.5 K182596Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1

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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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