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FDA 510(k)

HyperView Hyperspectral Tissue Oxygenation Measurement System

K-Number: K161237 · 2016-12-16

ApplicantHypermed Imaging, Inc.
Decision Date2016-12-16
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HyperView Hyperspectral Tissue Oxygenation Measurement System is a medical device manufactured by Hypermed Imaging, Inc.. It received FDA 510(k) clearance on 2016-12-16 under approval number K161237. 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 HyperView Hyperspectral Tissue Oxygenation Measurement System?

HyperView Hyperspectral Tissue Oxygenation Measurement System is a medical device that received FDA 510(k) clearance on 2016-12-16. It is manufactured by Hypermed Imaging, Inc.. The 510(k) number is K161237.

When was HyperView Hyperspectral Tissue Oxygenation Measurement System approved by the FDA?

HyperView Hyperspectral Tissue Oxygenation Measurement System received FDA 510(k) clearance on 2016-12-16, under approval number K161237.

What company makes HyperView Hyperspectral Tissue Oxygenation Measurement System?

HyperView Hyperspectral Tissue Oxygenation Measurement System is manufactured by Hypermed Imaging, Inc..

What is the FDA product code for HyperView Hyperspectral Tissue Oxygenation Measurement System?

The FDA product code for HyperView Hyperspectral Tissue Oxygenation Measurement System is MUD.

Related Clinical Trials

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Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026) PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025) PMID: 41028165 Validation and reliability of mechanical stiffness assessment tools in multilayered polyurethane phantom models of healthy and diabetic plantar soft tissues. Scientific reports (2025) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025)

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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.

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