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FDA 510(k)

X-VIEW, IMAGEN

K-Number: K151137 · 2016-06-07

ApplicantEdlen Imaging, LLC
Decision Date2016-06-07
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

X-VIEW, IMAGEN is a medical device manufactured by Edlen Imaging, LLC. It received FDA 510(k) clearance on 2016-06-07 under approval number K151137. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X-VIEW, IMAGEN?

X-VIEW, IMAGEN is a medical device that received FDA 510(k) clearance on 2016-06-07. It is manufactured by Edlen Imaging, LLC. The 510(k) number is K151137.

When was X-VIEW, IMAGEN approved by the FDA?

X-VIEW, IMAGEN received FDA 510(k) clearance on 2016-06-07, under approval number K151137.

What company makes X-VIEW, IMAGEN?

X-VIEW, IMAGEN is manufactured by Edlen Imaging, LLC.

What is the FDA product code for X-VIEW, IMAGEN?

The FDA product code for X-VIEW, IMAGEN is OAS.

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Official Source

View on FDA Database →

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