QUANTEM

K963162 · Elscint, Inc. · KPS · Nov 12, 1996 · Radiology

Device Facts

• Record ID: K963162
• Device Name: QUANTEM
• Applicant: Elscint, Inc.
• Product Code: KPS · Radiology
• Decision Date: Nov 12, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

QuantEM™ package is a renal analysis package for Tc-99m MAG3 renal images. The QuantEM™ method was developed at Emory University, Atlanta, GA for calculating the clearance of Tc-99m MAG3. It provides a comprehensive package consisting of processing and protocols to aid the technologist and physician in the performance and interpretation of Tc99m MAG3 renograms.

Device Story

QuantEM™ renal analysis software; processes Tc-99m MAG3 renal images; calculates renal clearance; aids technologist/physician in renogram interpretation. Implemented on Apex XPert workstation of Varicam gamma camera. Used in clinical nuclear medicine settings. Output provides quantitative renal data to support clinical decision-making regarding renal function.

Clinical Evidence

No clinical data provided. Effectiveness established via validation and testing of software processing results compared to previously cleared QuantEM™ implementation on GE Starcam computers.

Technological Characteristics

Software-based renal analysis package; operates on Apex XPert workstation platform; utilizes Tc-99m MAG3 imaging data; provides quantitative clearance calculations.

Indications for Use

Indicated for use by technologists and physicians to aid in the performance and interpretation of Tc-99m MAG3 renograms for renal clearance calculation.

Regulatory Classification

Identification

An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Predicate Devices

• QuantEM™ package on GE Starcam computers (K932957)
• Varicam's Apex XPert workstation (K953801)

Submission Summary (Full Text)

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NOV 12 1996
K963162

# Summary of Safety and Effectiveness

QuantEM™ package is a renal analysis package for Tc-99m MAG3 renal images. The QuantEM™ method was developed at Emory University, Atlanta, GA for calculating the clearance of Tc-99m MAG3. It provides a comprehensive package consisting of processing and protocols to aid the technologist and physician in the performance and interpretation of Tc99m MAG3 renograms.

The QuantEM™ package is implemented on the Apex XPert workstation of the Varicam gamma camera (K953801).

The effectiveness of the QuantEM™ package, implemented on the Apex XPert, is equivalent to the effectiveness of the QuantEM™ package implemented on GE Starcam computers (K932957).

The addition of the QuantEM™ package does not effect the safety and effectiveness of all other functions performed by the Apex XPert workstation.

Precautions to avoid erroneous processing results were taken and the necessary validation and tests were made to ensure correct processing results of the QuantEM™ package.

Based on the above, it is Elscint's opinion that the XPert QuantEM™ package usage is substantially equivalent in safety and effectiveness to QuantEM™ package on General Electric nuclear medicine computers (K932957), and that the Apex XPert workstation equipped with the QuantEM™ package is substantially equivalent in safety and effectiveness to the previously marketed version of the Varicam's Apex XPert workstation (K953801).