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FDA 510(k)

Xperius Ultrasound System

K-Number: K163020 · 2016-11-16

ApplicantPhilips Health Care
Decision Date2016-11-16
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Xperius Ultrasound System is a medical device manufactured by Philips Health Care. It received FDA 510(k) clearance on 2016-11-16 under approval number K163020. 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 Xperius Ultrasound System?

Xperius Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-11-16. It is manufactured by Philips Health Care. The 510(k) number is K163020.

When was Xperius Ultrasound System approved by the FDA?

Xperius Ultrasound System received FDA 510(k) clearance on 2016-11-16, under approval number K163020.

What company makes Xperius Ultrasound System?

Xperius Ultrasound System is manufactured by Philips Health Care.

What is the FDA product code for Xperius Ultrasound System?

The FDA product code for Xperius Ultrasound System is IYN.

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Other Devices by Philips Health Care

K162549Lumify Ultrasound System K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System K171314QLAB Advanced Quantification Software K191647QLAB Advanced Quantification Software K192226Lumify Diagnostic Ultrasound System

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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. K161999AixplorerSupersonic Imagine

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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