FDA 510(k)

Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System

K-Number: K232988 · 2023-11-21

ApplicantCanon Medical Systems Corporation

Decision Date2023-11-21

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2023-11-21 under approval number K232988. 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 flex and Aplio go Software V2.0 Diagnostic Ultrasound System?

Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2023-11-21. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K232988.

When was Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System approved by the FDA?

Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System received FDA 510(k) clearance on 2023-11-21, under approval number K232988.

What company makes Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System?

Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System is manufactured by Canon Medical Systems Corporation.

What is the FDA product code for Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System?

The FDA product code for Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System is IYN.

Related Clinical Trials

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Related PubMed Literature

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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.