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 the device name listed in this FDA 510(k) record. The listed applicant is Beijing East Whale Imaging Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-04-07 under 510(k) 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. The listed applicant is Beijing East Whale Imaging Technology Co., Ltd.. The 510(k) number is K160343.

When did SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner receive FDA 510(k) clearance?

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

Who is the listed applicant for SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner?

The FDA 510(k) record lists Beijing East Whale Imaging Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

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Official Source

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