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FDA 510(k)

Xperius Ultrasound System

K-Number: K182529 · 2018-10-23

ApplicantPhilips Ultrasound, Inc.
Decision Date2018-10-23
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Xperius Ultrasound System is a medical device manufactured by Philips Ultrasound, Inc.. It received FDA 510(k) clearance on 2018-10-23 under approval number K182529. 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 2018-10-23. It is manufactured by Philips Ultrasound, Inc.. The 510(k) number is K182529.

When was Xperius Ultrasound System approved by the FDA?

Xperius Ultrasound System received FDA 510(k) clearance on 2018-10-23, under approval number K182529.

What company makes Xperius Ultrasound System?

Xperius Ultrasound System is manufactured by Philips Ultrasound, Inc..

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 Ultrasound, Inc.

K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System K170716PercuNav Image Fusion and Interventional Navigation K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System K182857EPIQ Diagnostic Ultrasound System, 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 K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System K181264QLAB Advanced Quantification Software

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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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