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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 the device name listed in this FDA 510(k) record. The listed applicant is Edlen Imaging, LLC. It received FDA 510(k) clearance on 2016-06-07 under 510(k) 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. The listed applicant is Edlen Imaging, LLC. The 510(k) number is K151137.

When did X-VIEW, IMAGEN receive FDA 510(k) clearance?

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

Who is the listed applicant for X-VIEW, IMAGEN?

The FDA 510(k) record lists Edlen Imaging, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: OAS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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