FDA 510(k)

Ox-Imager CS

K-Number: K153426 · 2016-12-21

Decision Date2016-12-21

Product CodeMUD

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Ox-Imager CS is the device name listed in this FDA 510(k) record. The listed applicant is Modulated Imaging, Inc.. It received FDA 510(k) clearance on 2016-12-21 under 510(k) number K153426. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ox-Imager CS?

Ox-Imager CS is a medical device that received FDA 510(k) clearance on 2016-12-21. The listed applicant is Modulated Imaging, Inc.. The 510(k) number is K153426.

When did Ox-Imager CS receive FDA 510(k) clearance?

Ox-Imager CS received FDA 510(k) clearance on 2016-12-21, under 510(k) number K153426.

Who is the listed applicant for Ox-Imager CS?

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

What is the FDA product code for Ox-Imager CS?

The FDA product code for Ox-Imager CS is MUD.

Other records listing Modulated Imaging, Inc. as applicant

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