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FDA 510(k)

Stereo 3D option for Vision Applications

K-Number: K152352 · 2016-01-20

ApplicantGE Medical Systems SCS
Decision Date2016-01-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Stereo 3D option for Vision Applications is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems SCS. It received FDA 510(k) clearance on 2016-01-20 under 510(k) 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. The listed applicant is GE Medical Systems SCS. The 510(k) number is K152352.

When did Stereo 3D option for Vision Applications receive FDA 510(k) clearance?

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

Who is the listed applicant for Stereo 3D option for Vision Applications?

The FDA 510(k) record lists GE Medical Systems SCS as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: LLZ)

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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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