FDA 510(k)

5D Viewer

K-Number: K180883 · 2018-05-15

Decision Date2018-05-15

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

5D Viewer is a medical device manufactured by Samsung Medison Co., Ltd.. It received FDA 510(k) clearance on 2018-05-15 under approval number K180883. 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 5D Viewer?

5D Viewer is a medical device that received FDA 510(k) clearance on 2018-05-15. It is manufactured by Samsung Medison Co., Ltd.. The 510(k) number is K180883.

When was 5D Viewer approved by the FDA?

5D Viewer received FDA 510(k) clearance on 2018-05-15, under approval number K180883.

What company makes 5D Viewer?

5D Viewer is manufactured by Samsung Medison Co., Ltd..

What is the FDA product code for 5D Viewer?

The FDA product code for 5D Viewer is LLZ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.