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FDA 510(k)

Stereo 3D option for Vision Applications

K-Number: K152352 · 2016-01-20

Decision Date2016-01-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Stereo 3D option for Vision Applications is a medical device manufactured by GE Medical Systems SCS. It received FDA 510(k) clearance on 2016-01-20 under approval number K152352. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stereo 3D option for Vision Applications?

Stereo 3D option for Vision Applications is a medical device that received FDA 510(k) clearance on 2016-01-20. It is manufactured by GE Medical Systems SCS. The 510(k) number is K152352.

When was Stereo 3D option for Vision Applications approved by the FDA?

Stereo 3D option for Vision Applications received FDA 510(k) clearance on 2016-01-20, under approval number K152352.

What company makes Stereo 3D option for Vision Applications?

Stereo 3D option for Vision Applications is manufactured by GE Medical Systems SCS.

What is the FDA product code for Stereo 3D option for Vision Applications?

The FDA product code for Stereo 3D option for Vision Applications is LLZ.

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Official Source

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