HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION

K964746 · GE Medical Systems · JAK · Jan 24, 1997 · Radiology

Device Facts

• Record ID: K964746
• Device Name: HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION
• Applicant: GE Medical Systems
• Product Code: JAK · Radiology
• Decision Date: Jan 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

HiSpeed CT/i with Performix Tube and Warp Scan Option is intended to provide 0.8 second 360-degree helical or axial scans as well as increase the maximum tube heat capacity and provides additional mA settings over our existing system.

Device Story

CT imaging system; utilizes Performix metal-cased X-ray tube (6.3MHU heat capacity) and software control key (Warp Scan) to enable 0.8s full rotation and 0.5s partial scan speeds. Operated by radiology staff in clinical settings. System increases available power (up to 53kW) and mA range (10-440mA) compared to predicate. Output is diagnostic CT imagery used by radiologists for clinical decision-making. Benefits include improved scan speed and efficiency for CT examinations.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness supported by compliance with industry standards (UL 187, IEC 601-1) and Federal performance standards (21 CFR Subchapter J).

Technological Characteristics

Metal-cased X-ray tube (6.3MHU capacity); 0.8s full rotation/0.5s partial scan; 10-440mA range; 48-53kW power output. Materials/construction compliant with UL 187, IEC 601-1, and 21 CFR Subchapter J. Software control key enables speed options. Strengthened tube mounting.

Indications for Use

Indicated for patients requiring CT imaging; provides 0.8s helical/axial scans, increased tube heat capacity, and expanded mA settings for diagnostic imaging.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• HiSpeed CT/i (K940606)

Submission Summary (Full Text)

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Summary of Safety & Effectiveness

K964746

Product Identification:

JAN 24 1997

Name: HiSpeed CT/i with Performix Tube and Warp Scan Option
Submitting Correspondant: Larry Kroger - Regulatory Program Managers

Manufacturer: General Electric Medical Systems
16800 W. Ryerson Road
New Berlin, WI 53151

Distributor: Same as Manufacturer

Indications for Use:

HiSpeed CT/i with Performix Tube and Warp Scan Option is intended to provide 0.8 second 360-degree helical or axial scans as well as increase the maximum tube heat capacity and provides additional mA settings over our existing system.

Device Description:

The option is a software control key for the HiSpeed system that increases the allowable speed (Warp Scan), for single rotation to 0.8 seconds for axial and helical scanning as well as 0.5 second rotation for partial scan. The Performix tube provides an additional tube option for use on the HiSpeed Gantry. It is a metal cased tube that has a heat capacity of 6.3MHU. For HiSpeed CT/i systems the maximum available power increases. The new tube takes advantage of power capabilities of the power distribution unit that is currently provided with the system. The increase in available power will not require a change in hardware.

Materials: Materials and construction are equivalent to the HiSpeed CT/i and are compliant with UL 187, IEC 601-1, and 21 CFR Subchapter J

Design: The design of HiSpeed CT/i with Performix Tube and Warp Scan Option differs from the information covered in K940606 (HiSpeed CT/i) by the addition of the Performix tube which allows for the widening of mA specifications as well as the increased scan speed. Tube mounting has been strengthened with the new tube to allow for faster scanning.

Energy Source and Exposure Levels: Maximum available output power varies according to the power distribution unit on existing system (there are two possible PDUs in the installed base). 48 kw allows an mA range of 40 to 400 mA and 53 kW allows mA range from 10 to 440 mA. The Performix tube has a heat capacity of 6.3 million heat units (MHU). All else within the system remains the same as the HiSpeed CT/i K940606.

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Principals of Operation: Same as HiSpeed CT/i K940606.

Features: The features with this option differ from HiSpeed CT/i K940606 only by the additional range of mA available (10 to 440mA) as well as the faster scan speed, 0.8 sec for full scan rotation axials and helicals instead of 1 sec. Partial scan of 0.5 seconds instead of 0.6 sec.

Accessories: No new accessories with this option, all accessories used are the same as HiSpeed CT/i.

## Marketing History:

The HiSpeed CT/i with Performix Tube and Warp Scan Option is substantially equivalent to the currently marketed HiSpeed CT/i (K940606).

## Adverse Effects on Health:

Potential electrical, mechanical, and radiation hazards are controlled by compliance with industry standards (UL 187 and IEC 601-1), the Federal performance standard (21 CFR Subchapter J), and appropriate directions and warnings in the labeling.

## Conclusions:

The HiSpeed CT/i with Performix Tube and Warp Scan Option adds a tube option and increased speed options that intend to improve the speed and efficiency of CT exams. It is the same basic design as HiSpeed CT/i differing only in the tube used which allows for a broader range of mA selections. All other HiSpeed CT/i features are as submitted in K940606. The HiSpeed CT/i with Performix Tube and Warp Scan Option has no differences with regard to safety or effectiveness from HiSpeed CT/i.