CT PROSPEED CT/I

K961055 · GE Medical Systems · JAK · Jun 17, 1996 · Radiology

Device Facts

• Record ID: K961055
• Device Name: CT PROSPEED CT/I
• Applicant: GE Medical Systems
• Product Code: JAK · Radiology
• Decision Date: Jun 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The CT ProSpeed CT/i is indicated for head and whole body x-ray computed tomography applications. It provides axial, helical and scout imaging.

Device Story

X-ray computed tomography scanner; components include gantry, patient table, console, and computer. Inputs: X-ray radiation attenuated by patient anatomy. Processing: High-frequency on-board generator (42kW output) and computer workstation interface for image reconstruction. Outputs: Axial, helical, and scout CT images. Used in clinical radiology settings by trained technologists/radiologists. Output used for diagnostic visualization of internal structures. Benefits: Non-invasive diagnostic imaging for head and whole body applications.

Clinical Evidence

Bench testing only. System evaluation performed to ensure performance meets specifications and Federal Regulations. No clinical data provided.

Technological Characteristics

X-ray CT scanner; 3.5MHU tube capacity; 42kW high-frequency generator; 208-480 Vac power. Materials compliant with UL 187, IEC 601-1, and 21 CFR Subchapter J. Provides axial, helical, and scout imaging modes.

Indications for Use

Indicated for head and whole body x-ray computed tomography imaging in patients requiring axial, helical, or scout scans.

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 (K944013)
• HiSpeed CT/i (K940606)

Submission Summary (Full Text)

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K96/055
GE Medical Systems
JUN 17 1996
General Electric Company
P.O. Box 414, Milwaukee, WI 53201

# Summary of Safety & Effectiveness
## 15 March 1996

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).

**Contact:** Larry Kroger
**Phone:** 414-544-3894
**Fax:** 414-544-3863

## Product Identification:

**Name:** CT ProSpeed CT/i
**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

## Indications for Use:

The CT ProSpeed CT/i is indicated for head and whole body x-ray computed tomography applications. It provides axial, helical and scout imaging.

## Device Description:

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

**Materials:** Materials and construction are equivalent to the CT ProSpeed Plus and 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 HiLight Detector (K944013) the difference being that it uses a computer workstation user interface similar to our HiSpeed CT/i (K 940606).

**Energy Source and Exposure Levels:** The energy source is can be over the range of 208 to 480 Vac 50/60 Hz.
- 3.5MHU tube capacity,
- high frequency on-board generator
- 42kW output power
- CTDI at 120kVp, 300 mAs, 1s scan for body, 1.5 s scan for head, 10mm aperture:
- Center: Head 60 mGy (6.0 Rad) Body 17 mGy (1.7 Rad)
- Surface: Head 62 mGy (6.2 Rad) Body 31 mGy (3.2 Rad)

100 Years of Radiology
1895 - 1995

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Marketing History:

It is the opinion of GE Medical Systems that the ProSpeed
CT/i is of a comparable type and substantially equivalent to
currently marketed head and whole body x-ray computed
tomography systems.

Adverse Effects on Health:

Potential electrical, mechanical and radiation hazards are
identified in a hazard analysis and controlled by:
- Failure Mode Effects Analysis to demonstrate the
non-existence or extremely low probability of unwanted
events.
- System evaluation to insure performance to
specifications and Federal Regulations.
- Adherence to Industry and International Standards.
(UL and IEC)

Conclusions:

Use of the ProSpeed CT/i does not result in any new
potential safety risks.