MOBILE CT PROSPEED FAMILY

K963896 · GE Medical Systems · JAK · Dec 18, 1996 · Radiology

Device Facts

• Record ID: K963896
• Device Name: MOBILE CT PROSPEED FAMILY
• Applicant: GE Medical Systems
• Product Code: JAK · Radiology
• Decision Date: Dec 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The Mobile CT ProSpeed is indicated for head and whole body x-ray computed tomography applications to be mounted in a trailer. The Mobile CT ProSpeed has the same indications for use as the CT ProSpeed Plus (formerly known as CT Sytoc 8000 K913485) and CT ProSpeed Family with HiLight Detector K944013.

Device Story

Mobile CT ProSpeed; x-ray computed tomography scanner; consists of gantry, patient table, console, computer, accessories; mounted within trailer for transport between medical facilities. Operates via same principles, energy sources, and x-ray tube/generator as predicate CT ProSpeed systems. Used by clinicians to provide diagnostic CT services in areas lacking fixed installations. Output consists of CT images for clinical decision-making; facilitates patient access to imaging and reduces healthcare costs.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness supported by equivalence to predicate devices and compliance with established electrical, mechanical, and radiation safety standards (UL 187, IEC 601-1, 21 CFR Subchapter J).

Technological Characteristics

X-ray CT scanner; gantry, table, console, computer. Materials/construction compliant with UL 187, IEC 601-1, 21 CFR Subchapter J. Energy source: x-ray tube and generator identical to predicates. Mobile configuration via trailer mounting with reinforced table/gantry bolts.

Indications for Use

Indicated for head and whole body x-ray computed tomography applications in patients requiring diagnostic imaging, mounted in a mobile trailer environment.

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

• CT ProSpeed Plus (K913485)
• CT ProSpeed Family with HiLight Detector (K944013)

Submission Summary (Full Text)

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DEC 18 1996

# Summary of Safety & Effectiveness

## Product Identification:

**Name:** Mobile CT ProSpeed

**Manufacturer:** GE - Yokogawa Medical Systems
7-127 Asahigaoka, Hino-shi
4-chome, Tokyo 191, Japan

**Distributor:** GE Medical Systems
3000 N. Grandview
Waukesha, WI 53188
K963896

**Mobile Coach:** Calumet Coach Co.
2150 Dolton Ave.
Calumet City, IL 60409

## Indications for Use:

The Mobile CT ProSpeed is indicated for head and whole body x-ray computed tomography applications to be mounted in a trailer. The Mobile CT ProSpeed has the same indications for use as the CT ProSpeed Plus (formerly known as CT Sytoc 8000 K913485) and CT ProSpeed Family with HiLight Detector K944013.

## Device Description:

The device is an x-ray computed tomography scanner consisting of a gantry, patient table, console, computer, and associated accessories, mounted within a trailer.

**Materials:** Materials and construction are equivalent to the CT ProSpeed Plus and are CT ProSpeed Family with HiLight Detector which are compliant with UL 187, IEC 601-1, and 21 CFR Subchapter J.

**Design:** The design is essentially the same as the CT ProSpeed with larger mounting bolts for the table and gantry as well as special instructions for the set-up and take down of the system.

**Energy Source and Exposure Levels:** The energy source is the same as the CT ProSpeed Plus and CT ProSpeed Family with HiLight Detector with the same x-ray tube and generator.

**Principals of Operation:** The same as the CT ProSpeed Plus and CT ProSpeed Family with HiLight Detector.

**Features:** The same as the CT ProSpeed Plus and CT ProSpeed Family with HiLight Detector.

**Accessories:** The same accessories as the CT ProSpeed Plus and CT ProSpeed Family with HiLight Detector.

## Marketing History:

The CT Mobile ProSpeed is substantially equivalent to the currently marketed CT ProSpeed Plus (K913485) and CT ProSpeed Family with HiLight Detector (K944013).

## Adverse Effects on Health:

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

## Conclusions:

The CT Mobile ProSpeed is intended to provide a CT scanner capable of being transported between or shared with other medical facilities to help reduce health care costs and provide CT services to areas where they might not otherwise have them. It is substantially equivalent to the CT ProSpeed Plus and in design, CT ProSpeed Family with HiLight Detector construction, energy source, exposure level, principle of operation, features, and accessories.