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FDA 510(k)

SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner

K-Number: K160343 · 2016-04-07

ApplicantBeijing East Whale Imaging Technology Co., Ltd.
Decision Date2016-04-07
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner is a medical device manufactured by Beijing East Whale Imaging Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-04-07 under approval number K160343. 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 SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner?

SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner is a medical device that received FDA 510(k) clearance on 2016-04-07. It is manufactured by Beijing East Whale Imaging Technology Co., Ltd.. The 510(k) number is K160343.

When was SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner approved by the FDA?

SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner received FDA 510(k) clearance on 2016-04-07, under approval number K160343.

What company makes SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner?

SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner is manufactured by Beijing East Whale Imaging Technology Co., Ltd..

What is the FDA product code for SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner?

The FDA product code for SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner is IYN.

Related Clinical Trials

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Other Devices by Beijing East Whale Imaging Technology Co., Ltd.

K160984MultiScan G-Arm System K163429B6

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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