SOMATOM PLUS 4 CT SCANNER

K964747 · Siemens Medical Solutions USA, Inc. · JAK · Feb 10, 1997 · Radiology

Device Facts

• Record ID: K964747
• Device Name: SOMATOM PLUS 4 CT SCANNER
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: JAK · Radiology
• Decision Date: Feb 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The SOMATOM Plus 4 CT Scanner is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles. * The axial planes resulted from the continuous rotation of detectors and X-ray tube and the simultaneous translation of the patient.

Device Story

Whole body CT scanner; utilizes continuously rotating tube-detector system; operates on fan beam principle. Inputs: X-ray transmission data. Processing: computer reconstruction of data from multiple angles (axial or spiral). Output: cross-sectional body images. Used in clinical radiology settings; operated by trained radiologic technologists/physicians. Output used by clinicians for diagnostic visualization and clinical decision-making. Benefits: improved low contrast resolution and reduced image noise via solid state detector technology.

Clinical Evidence

Bench testing only. No clinical data provided. Equivalence established through technical comparison of detector performance (conversion efficiency, resolution, noise reduction).

Technological Characteristics

Whole body CT X-ray system; fan beam geometry; continuously rotating tube-detector gantry. Features optional solid state detector (replacing xenon detector). Software: Somaris 4/B30. Connectivity: standard CT imaging system architecture.

Indications for Use

Indicated for patients requiring cross-sectional body imaging via computed tomography X-ray reconstruction.

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

• SOMATOM Plus 4 CT Scanner (K941546)
• HiSpeed Advantage (K940606)

Submission Summary (Full Text)

{0}

SIEMENS
FEB 10 1997
K964747

Attachment 12

510(k) Summary

Siemens SOMATOM Plus 4 Computed Tomography (CT) Scanner
with Somaris 4/B30 Software

Submitted by:

Siemens Medical Systems, Inc.
186 Wood Avenue South
Iselin, NJ 08830

November 25, 1996

This 510(k) summary of safety and effectiveness information is being
submitted in accordance with the requirements of SMDA 1990 and 21 CFR
§807.92.

1. Contact Person:

Ms. Jing Zhang
Phone: [phone] Fax: [phone]

2. Device Name and Classification:

Trade Name: SOMATOM Plus 4 CT Scanner
Classification Name: Computed Tomography X-ray System
Classification Panel: Radiology
CFR Section: 21 CFR §892.1750
Device Class: Class II
Device Code: 90JAK

3. Intended Use:

The SOMATOM Plus 4 CT Scanner is intended to produce cross-
sectional images of the body by computer reconstruction of X-ray
transmission data from either the same axial plane taken at different
angles or spiral planes* taken at different angles.

* The axial planes resulted from the continuous rotation of detectors and X-ray tube and the
simultaneous translation of the patient.

Simplified 510(k) for modified SOMATOM Plus 4 Siemens Medical Systems, Inc. Pg. 28 of 31

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Simplified 510(k) for modified SOMATOM Plus 4 Siemens Medical Systems, Inc. Pg. 29 of 31

# SIEMENS

## 4. Substantial Equivalence:

The new SOMATOM Plus 4 CT Scanner is substantially equivalent to the following devices in commercial distribution:

- SOMATOM Plus 4 CT Scanner, K941546
Siemens Medical Systems, Inc.
- HiSpeed Advantage, K940606
GE

## 5. Device Description:

The SOMATOM Plus 4 with Somaris 4/B30 software is a whole body computed tomography X-ray scanner, which features a continuously rotating tube-detector system and functions according to the fan beam principle.

## 6. Summary of Technological Characteristics of the Device Compared to the Predicate Device:

The SOMATOM Plus 4 operating with Somaris 4/B30 software has the same technological characteristics as the predicate Plus 4 operating with Somaris 4/B20 software, except the addition of an optional solid state detector. The change from xenon detector to solid state detector does not change the overall design and operation of the Plus 4 scanner. Since the solid state detector has a higher conversion efficiency, the low contrast resolution is improved and the image noise is reduced.


Kathleen Rutherford
Manager, Regulatory Submissions
Siemens Medical Systems, Inc.