C.A.R.E. VISION FOR THE SOMATOM PLUS 4 CT SCANNER

K965004 · Siemens Medical Solutions USA, Inc. · JAK · Mar 11, 1997 · Radiology

Device Facts

• Record ID: K965004
• Device Name: C.A.R.E. VISION FOR THE SOMATOM PLUS 4 CT SCANNER
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: JAK · Radiology
• Decision Date: Mar 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The C.A.R.E. VISION is intended to be used for instant display of CT images during interventional procedures using CT scanners. Instant image reconstruction of 3-9 images per second allows the physician to watch the placement of an interventional instrument real time.

Device Story

C.A.R.E. VISION is a software/firmware upgrade for SOMATOM Plus 4 CT scanners; enables real-time CT imaging during interventional procedures. System reconstructs and displays 3-9 images per second; allows physicians to monitor interventional instrument placement in real-time. Operates in clinical settings; integrates with existing CT scan modes; allows switching to standard sequence scanning for enhanced image quality. Benefits include improved visualization of instrument positioning during procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use comparison to predicate devices.

Technological Characteristics

Software/firmware upgrade for SOMATOM Plus 4 CT scanner; enables real-time image reconstruction (3-9 images/sec). Operates as an add-on scan mode for existing CT hardware.

Indications for Use

Indicated for patients undergoing interventional procedures requiring real-time CT image guidance for instrument placement.

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 (Siemens Medical Systems, Inc.)
• Real Time Reconstruction System Option for Xpress/SX CT System (Toshiba America Medical Systems, Inc.)

Submission Summary (Full Text)

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SIEMENS
MAR 11 1997
Appendix 1
K965004

# 510(k) Summary

## C.A.R.E. VISION Option for SOMATOM Plus 4 CT System

Submitted by:

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

December 13, 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: C.A.R.E. VISION for the SOMATOM Plus 4 CT
Classification Name: Computed Tomography X-ray System
Classification Panel: Radiology
CFR Section: 21 CFR §892.1750, Class II
Device Code: 90JAK

3. Substantial Equivalence:
The C.A.R.E. VISION option operating on SOMATOM Plus 4 CT scanner is substantially equivalent to the following devices:

1) SOMATOM Plus 4 CT
Siemens Medical Systems, Inc., for scanning

2) Real Time Reconstruction System Option for Xpress/SX CT System
Toshiba America Medical Systems, Inc. for real time image reconstruction and display

4. Device Description:
The C.A.R.E. VISION option is a new scan mode added to the SOMATOM Plus 4 CT scanner. The option can be installed in the factory or in the field via an upgrade kit consisting of hardware, software and firmware.

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# SIEMENS

Under C.A.R.E. VISION, three to nine images are reconstructed and displayed per second, effectively simulating a real-time display presentation. More than one C.A.R.E. VISION scans can be set-up and performed one after the other. C.A.R.E. VISION can also be mixed with other scan modes. Switch to SEQUENCE scan mode can be initiated any time during C.A.R.E. VISION thus a particular phase of the operation can be displayed in enhanced image quality.

## 5. Intended Use of the Device:

The C.A.R.E. VISION is intended to be used for instant display of CT images during interventional procedures using CT scanners. Instant image reconstruction of 3-9 images per second allows the physician to watch the placement of an interventional instrument real time.

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

The C.A.R.E. Vision has the same technological characteristics as the Real Time Reconstruction System Option for Xpress/SX CT System from Toshiba America Medical Systems, Inc. They both provide real time reconstruction and display of the CT images that can be used in conventional interventional CT exams.


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