Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Ox-Imager CS

K-Number: K153426 · 2016-12-21

ApplicantModulated Imaging, Inc.
Decision Date2016-12-21
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Ox-Imager CS is a medical device manufactured by Modulated Imaging, Inc.. It received FDA 510(k) clearance on 2016-12-21 under approval 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. It is manufactured by Modulated Imaging, Inc.. The 510(k) number is K153426.

When was Ox-Imager CS approved by the FDA?

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

What company makes Ox-Imager CS?

Ox-Imager CS is manufactured by Modulated Imaging, Inc..

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

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

Other Devices by Modulated Imaging, Inc.

K181623Clarifi Imaging System

Related Devices (Code: MUD)

K161237HyperView Hyperspectral Tissue Oxygenation Measurement SystemHypermed Imaging, Inc. K162117NIRO-200NX DPHamamatsu Photonics K.K. K160526Masimo O3 Regional Oximeter SystemMasimo Corporation K163472Intra.Ox Handheld Tissue OximeterVioptix, Inc. K162603Masimo O3 Regional Oximeter SystemMasimo Corporation K163070Kent CameraKent Imaging, Inc.

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.

↑