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510(k) Data Aggregation
K Number
K073656Device Name
OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM
Manufacturer
HYPERMED, INC.
Date Cleared
2008-01-25
(30 days)
Product Code
MUD
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
HYPERMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OxyVu™-1 Hyperspectral Tissue Oxygenation (HTO) Measurement System is intended for use by healthcare professionals as a non-invasive tissue oxygenation measurement system that reports an approximate value of:
- . oxygen saturation (HT-Sat),
- oxyhemoglobin level (HT-Oxy), and .
- deoxyhemoglobin (HT-Deoxy) level .
in superficial tissue. The Oxy Vu™-1 system displays two-dimensional colorcoded images of tissue oxygenation of the scanned surface and reports hyperspectral tissue oxygenation measurements for selected tissue regions.
The OxyVu™-1 system is indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise.
Device Description
The OxyVu™-1 system is based on hyperspectral imaging technology. The technology performs spectral analysis at each point in a two-dimensional scanned area producing an image displaying information derived from the analysis. For the Oxy Vu™-1 system, the spectral analysis determines in superficial tissues approximate values of oxygen saturation (HT-Sat), oxyhemoglobin levels (HToxy), and deoxyhemoglobin levels (HT-deoxy). The OxyVu™-1 system displays the tissue oxygenation in a two-dimensional, color-coded image.
The system consists of:
- System console: cart, system electronics, CPU, monitor, keyboard, pointing . device and printer.
- Hyperspectral imaging instrument head with support arm: broadband . illuminator, camera and spectral filter for collecting hyperspectral imaging cube.
- Single use Oxy VuTM Check Pads and Targets: The Oxy VuTM Check Pad is . used to perform an instrument check prior to patient measurements. The OxyVu™ Target is placed within the intended field of view and is used as a fiduciary mark for image registration and for focusing.
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K Number
K061848Device Name
HYPERSPECTRAL TISSUE OXYGENATION MEASUREMENT SYSTEM, MODEL OXY VU1
Manufacturer
HYPERMED, INC.
Date Cleared
2006-11-08
(131 days)
Product Code
MUD
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
HYPERMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OxyVu-1 Hyperspectral Tissue Oxygenation (HTO) Measurement System is intended for use by healthcare professionals as a non-invasive tissue oxygenation measurement system that reports an approximate value of:
- oxygen saturation (HT-Sat),
- oxyhemoglobin level (HT-Oxy), and
- deoxyhemoglobin (HT-Deoxy) level
in superficial tissue. The OxyVu-1 system displays two-dimensional color-coded images of tissue oxygenation of the scanned surface and reports hyperspectral tissue oxygenation measurements for selected tissue regions.
The OxyVu-1 system is indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise.
Device Description
The OxyVu-1 system is based on hyperspectral imaging technology. The technology performs spectral analysis at each point in a two-dimensional scanned area producing an image displaying information derived from the analysis. For the OxyVu-1 system, the spectral analysis determines in superficial tissues approximate values of oxygen saturation (HT-Sat), oxyhemoglobin levels (HT-oxy), and deoxyhemoglobin levels (HT-deoxy). The OxyVu-1 system displays the tissue oxygenation in a two-dimensional, color-coded image.
The system consists of:
- System console: cart, system electronics, CPU, monitor, keyboard, pointing device and printer.
- Hyperspectral instrument head with support arm: broadband illuminator, camera and spectral filter for collecting hyperspectral imaging cube.
- Single use OxyVu Check Pads and Targets: The OxyVu Check Pad is used to perform an instrument check prior to patient measurements. The OxyVu Target is placed within the intended field of view and is used as a fiduciary mark for image registration and for focusing.
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