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FDA 510(k)

ULab Systems Treatment Planning Software

K-Number: K171295 · 2018-01-09

ApplicantUlab Systems, Inc.
Decision Date2018-01-09
Product CodePNN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ULab Systems Treatment Planning Software is a medical device manufactured by Ulab Systems, Inc.. It received FDA 510(k) clearance on 2018-01-09 under approval number K171295. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULab Systems Treatment Planning Software?

ULab Systems Treatment Planning Software is a medical device that received FDA 510(k) clearance on 2018-01-09. It is manufactured by Ulab Systems, Inc.. The 510(k) number is K171295.

When was ULab Systems Treatment Planning Software approved by the FDA?

ULab Systems Treatment Planning Software received FDA 510(k) clearance on 2018-01-09, under approval number K171295.

What company makes ULab Systems Treatment Planning Software?

ULab Systems Treatment Planning Software is manufactured by Ulab Systems, Inc..

What is the FDA product code for ULab Systems Treatment Planning Software?

The FDA product code for ULab Systems Treatment Planning Software is PNN.

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Related PubMed Literature

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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.

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