MEDTRONIC SOFAMOR DANEK, INC. 7221640 CD HORIZON® Spinal System

The IntelliSpace Portal V6.5 processes clinical images from a SBI* series that was generated by Philips IQon system and enables advanced visualization of the images. When used by qualified personnel, it provides useful diagnostic information. IntelliSpace Portal V6.5 can be used remotely by multiple users with compatible devices *SBI: Spectral Base Images. A set of dataset that are being used as the inputs for calculation of Spectral results that are being used for reading.

The IntelliSpace Portal IX V6.5 processes clinical images from a SBI* series that was generated by Philips IQon system and enables advanced visualization of the images. When used by qualified personnel, it provides useful diagnostic information. IntelliSpace Portal IX V6.5 can be used remotely by multiple users with compatible devices *SBI: Spectral Base Images. A set of dataset that are being used as the inputs for calculation of Spectral results that are being used for reading.

Powder-free textured;The packages of proposed device including immediate package, middle box package and outer carton package.Immediate package quantity: 1 pairMiddle box package quantity: 50 pairsOuter carton package quantity: 400 pairs

Stand alone software application.

This very lightly used versatile system enables clinicians to evaluate bone health, body composition, and cardiovascular risk.

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The IntelliSpace Portal V6.5 processes clinical images from a SBI* series that was generated by Philips IQon system and enables advanced visualization of the images. When used by qualified personnel, it provides useful diagnostic information. IntelliSpace Portal V6.5 can be used remotely by multiple users with compatible devices *SBI: Spectral Base Images. A set of dataset that are being used as the inputs for calculation of Spectral results that are being used for reading.

The IntelliSpace Portal IX V6.5 processes clinical images from a SBI* series that was generated by Philips IQon system and enables advanced visualization of the images. When used by qualified personnel, it provides useful diagnostic information. IntelliSpace Portal IX V6.5 can be used remotely by multiple users with compatible devices *SBI: Spectral Base Images. A set of dataset that are being used as the inputs for calculation of Spectral results that are being used for reading.

Powder-free textured;The packages of proposed device including immediate package, middle box package and outer carton package.Immediate package quantity: 1 pairMiddle box package quantity: 50 pairsOuter carton package quantity: 400 pairs

Stand alone software application.