PHILIPS TOMOSCAN AV EXPANDER UPGRADE

K964318 · Philips Medical Systems North America, Inc. · JAK · Jan 10, 1997 · Radiology

Device Facts

• Record ID: K964318
• Device Name: PHILIPS TOMOSCAN AV EXPANDER UPGRADE
• Applicant: Philips Medical Systems North America, Inc.
• Product Code: JAK · Radiology
• Decision Date: Jan 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Device Story

Philips TOMOSCAN AVE Upgrade is a hardware/software enhancement package for the Tomoscan SR 7000 CT system. Components include Rapidview Reconstructor and interface package. Enables 7 mm slice thickness and table speeds of 7 and 14 mm/sec. System utilizes X-ray tube and detectors to acquire CT data. Reconstructor facilitates 1-second image reconstruction. Used in clinical radiology settings by trained technicians/radiologists. Output consists of reconstructed CT images for diagnostic interpretation. Upgrade maintains original intended use of the host SR 7000 system; does not alter clinical applications or effectiveness.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance with 21 CFR Part 1020.33, IEC-601, and UL-187 standards cited.

Technological Characteristics

Upgrade package includes Rapidview Reconstructor and interface package. Enables 7 mm slice thickness and table speeds of 7/14 mm/sec. Complies with 21 CFR Part 1020.33, IEC-601, and UL-187. Hardware/software integration with existing SR 7000 CT system.

Indications for Use

Indicated for diagnostic computed tomography imaging of patients, consistent with the intended use of the existing Tomoscan SR 7000 CT system.

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

• TOMOSCAN AVE CT system (K954255)
• Tomoscan SR 7000 (K924082)

Reference Devices

• SR8000

Submission Summary (Full Text)

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PHILIPS

PHILIPS

JAN 10 1997

Philips Medical Systems

K964318

# Summary of Safety and Effectiveness

CLASSIFICATION NAME: Computed Tomography X-ray System Class II -21 CFR 892.1750

COMMON/USUAL NAME: CT X-ray System

TRADE/PROPRIETARY NAME: Philips TOMOSCAN AVE Upgrade

ESTABLISHMENT No. 1217116

PERFORMANCE STANDARDS: 21 CFR Part 1020.33, IEC-601, and UL-187.

# SYSTEM DESCRIPTION:

The Philips Tomoscan AV Expander Upgrade is an upgrade package to be installed on the existing Tomoscan SR 7000 (K924082). It is comprised of components and capabilities taken from the TOMOSCAN AVE CT system which has been cleared for commercial distribution by Premarket Notification submission K954255.

Identified components of the Expander Upgrade are the Rapidview Reconstructor, and an interface package; the included capabilities include a 7 mm slice thickness, and table speeds of 7 and 14 mm/sec. The AV Expander Upgrade does not alter the intended use of the CT system to which it is attached, nor does it differ from the SR8000. The resultant changes in specification do not affect clinical applications or effectiveness of the device. The X-ray tube and the different detectors will be the major difference between an upgraded SR 7000 and the Tomoscan AVE (SR 8000).

The AVE Upgrade is intended to address the primary operational differences between the Tomoscan SR 8000 and SR 7000:

| Hardware/Software Content | Functional Changes |
| --- | --- |
| -Rapidview Reconstructor | -1 sec reconstruction |
| -Interface package (Net Interface) | -7 mm slice thickness, |
| | -Table speeds of 7 and 14 mm/sec |

# SAFETY INFORMATION:

Computed Tomography is a mature technology with which the industry and users have many years of experience. These devices must comply with the appropriate sections of the Radiation Control for Health and Safety Act. A Product Report will be submitted prior to first delivery. Additionally, Philips CT systems are designed to be in compliance with National and International safety standards.

Philips Medical Systems
North America Company
710 Bridgeport Avenue
Shelton, CT 06484-4708
Tel: [phone]
Fax: [phone]