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FDA 510(k)

SmartView 3D Option

K-Number: K153429 · 2016-03-09

ApplicantGe Hangwei Medical System Co., Ltd.
Decision Date2016-03-09
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SmartView 3D Option is a medical device manufactured by Ge Hangwei Medical System Co., Ltd.. It received FDA 510(k) clearance on 2016-03-09 under approval number K153429. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SmartView 3D Option?

SmartView 3D Option is a medical device that received FDA 510(k) clearance on 2016-03-09. It is manufactured by Ge Hangwei Medical System Co., Ltd.. The 510(k) number is K153429.

When was SmartView 3D Option approved by the FDA?

SmartView 3D Option received FDA 510(k) clearance on 2016-03-09, under approval number K153429.

What company makes SmartView 3D Option?

SmartView 3D Option is manufactured by Ge Hangwei Medical System Co., Ltd..

What is the FDA product code for SmartView 3D Option?

The FDA product code for SmartView 3D Option is JAK.

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Official Source

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