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FDA 510(k)

Advanced Medical Imaging Software Suite (KSWVWR)

K-Number: K160334 · 2016-06-21

ApplicantKeosys Sas
Decision Date2016-06-21
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Advanced Medical Imaging Software Suite (KSWVWR) is a medical device manufactured by Keosys Sas. It received FDA 510(k) clearance on 2016-06-21 under approval number K160334. 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 Advanced Medical Imaging Software Suite (KSWVWR)?

Advanced Medical Imaging Software Suite (KSWVWR) is a medical device that received FDA 510(k) clearance on 2016-06-21. It is manufactured by Keosys Sas. The 510(k) number is K160334.

When was Advanced Medical Imaging Software Suite (KSWVWR) approved by the FDA?

Advanced Medical Imaging Software Suite (KSWVWR) received FDA 510(k) clearance on 2016-06-21, under approval number K160334.

What company makes Advanced Medical Imaging Software Suite (KSWVWR)?

Advanced Medical Imaging Software Suite (KSWVWR) is manufactured by Keosys Sas.

What is the FDA product code for Advanced Medical Imaging Software Suite (KSWVWR)?

The FDA product code for Advanced Medical Imaging Software Suite (KSWVWR) is 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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