FDA 510(k)

Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0

K-Number: K191467 · 2019-07-19

ApplicantCanon Medical Systems Corporation

Decision Date2019-07-19

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2019-07-19 under approval number K191467. 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/i800/i700/i600 Diagnostic Ultrasound System, V4.0?

Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 is a medical device that received FDA 510(k) clearance on 2019-07-19. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K191467.

When was Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 approved by the FDA?

Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 received FDA 510(k) clearance on 2019-07-19, under approval number K191467.

What company makes Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0?

Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 is manufactured by Canon Medical Systems Corporation.

What is the FDA product code for Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0?

The FDA product code for Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 is IYN.

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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.