SIREGRAPH CF

K960266 · Siemens Medical Solutions USA, Inc. · JAA · Mar 11, 1996 · Radiology

Device Facts

• Record ID: K960266
• Device Name: SIREGRAPH CF
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: JAA · Radiology
• Decision Date: Mar 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The Siemens Siregraph CF is a remote overtable radiographic/fluoroscopic x-ray diagnostic system that was designed for universal implementation in the hospital and clinical environment. The Siregraph CF, remote X-ray system, has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urinary tract, lymphography, myelography, venography, arthrography angiography and DSA.

Device Story

Siregraph CF is a remote-controlled, overtable radiographic/fluoroscopic X-ray system for hospital/clinical use. System features motorized table tilt (+90° to -18°) and motorized telescoping X-ray tube/spot film arm with 150 cm maximum SID. Supports linear tomography at 40°, 20°, and 8° angles. Can be configured with overhead tube support for Bucky Wall Stand exposures. Operated by trained healthcare professionals. System integrates various X-ray components (image intensifier, tube, collimator, generator) and television systems (Videomed DI/SX). Safety features include visual/audible warnings and automated error monitoring/blocking. Output is diagnostic X-ray imagery used by clinicians to perform examinations and inform clinical decisions.

Clinical Evidence

Bench testing only. The device conforms to 21 CFR Subchapter J performance standards. No clinical data provided.

Technological Characteristics

Remote-controlled overtable X-ray system. Components: image intensifier, X-ray tube/housing, spotfilm device, Bucky Wall stand, collimator, generator, and Videomed DI/SX television systems. Motorized table tilt (+90° to -18°). Motorized telescoping arm (max SID 150 cm). Linear tomography capability. Complies with 21 CFR Subchapter J. System includes visual/audible safety warnings and automated error monitoring.

Indications for Use

Indicated for patients requiring radiographic and fluoroscopic diagnostic imaging, including gastrointestinal, cranial, skeletal, thoracic, lung, urinary tract, lymphography, myelography, venography, arthrography, angiography, and DSA examinations.

Regulatory Classification

Identification

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Sireskop SX (K951358)
• Prestilix 1600X (K924310)
• Diagnost 96 (K912470)

Submission Summary (Full Text)

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SIEMENS

k960266

# 510(k) SUMMARY

## I. GENERAL INFORMATION:

### Establishment:

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

- Registration Number: 2240869

- Contact Person: Kathleen Rutherford
Manager, Regulatory Submissions
Telephone: [phone]
TELEFAX: [phone]

### Date of Summary Preparation:

### Device Name:

- Trade Name: Siregraph CF

- Common Name: Remote Multi-functional Overtable X-ray Diagnostic System

- Classification Name: Image Intensified Fluoroscopic X-ray System

- Classification: Class II

### Performance Standards:

21 CFR, Subchapter J

All system components to which the above standard applies are certified to conform with 21 CFR subchapter J

## II. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL EQUIVALENCE DETERMINATION.

### Device Description:

The Siemens Siregraph CF is a multifunctional, overtable X-ray diagnostic system that was developed for remote examinations. The Siregraph CF has a motorized table tilt from $+90^{\circ}$ to $-18^{\circ}$. The Siregraph CF X-ray tube/spot film system is equipped with a motorized telescoping arm which can be extended to a maximum SID of $150~\mathrm{cm}$. The x-ray tube/spot film device can be programmed to perform linear tomography (planigraphy) at three different angles; $40^{\circ}$ with a tomographic range of $113~\mathrm{cm}$, $20^{\circ}$ with a tomographic range of $131~\mathrm{cm}$ and $8^{\circ}$ with a tomographic range of $142~\mathrm{cm}$. In addition to the overtable tube the Siregraph CF can be configured with an overhead tube support for exposures using Bucky Wall Stand.

Siemens Medical Systems, Inc.

Imaging Systems Group

186 Wood Avenue South

Iselin, NJ 08830

Tel: [phone]

Fax: [phone]

11

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# SIEMENS

## Intended Use:

The Siemens Siregraph CF is a remote overtable radiographic/fluoroscopic x-ray diagnostic system that was designed for universal implementation in the hospital and clinical environment. The Siregraph CF, remote X-ray system, has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urinary tract, lymphography, myelography, venography, arthrography angiography and DSA.

## Technological Characteristics:

The Siregraph CF is not a stand alone device, but functions as a platform for specific X-ray components (image intensifier, X-ray tube and housing, spotfilm device, Bucky Wall stand, collimator, generator, etc.) and television systems (Videomed DI and Videomed SX) to create a flexible remote radiographic/fluoroscopic x-ray system.

## General Safety and Effectiveness Concerns:

Instructions for use are included within the device labeling and the information provided will enable the user to operate the device in a safe and efficacious manner. Several safety features including visual and audible warnings are incorporated into the system design. Furthermore, Siregraph CF is continually monitored, and if an error occurs, the system function will be blocked and an error message displayed. The operators of this generator are trained health care professionals familiar with and responsible for the X-ray studies to be performed. To minimize electrical, mechanical and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing.

## Substantial Equivalence:

The Siregraph CF remote Radiographic/fluoroscopic X-ray diagnostic system for universal implementation in radiographic/fluoroscopic procedures, and the subject of this premarket notification, is substantially equivalent to the following medical devices currently in commercial distribution.

| Model | Company | FDA K-Number |
| --- | --- | --- |
| Sireskop SX | Siemens Medical Systems, Inc. | K951358 |
| Prestilix 1600X | GE Medical Systems | K924310 |
| Diagnost 96 | Philip Medical Systems | K912470 |