ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM

K964659 · Dentsply Intl. · EHD · Dec 23, 1996 · Dental

Device Facts

• Record ID: K964659
• Device Name: ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM
• Applicant: Dentsply Intl.
• Product Code: EHD · Dental
• Decision Date: Dec 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The Orthoralix E/GX-9000™ Panoramic Dental X-Ray System is used as an extraoral source of x-rays in dental radiography.

Device Story

High-frequency panoramic dental X-ray system; produces extraoral radiographic images. System components: wall-mounted column, counter-balanced overhead carriage, X-ray tubehead, cassette drive system (15x30cm film), and microprocessor-controlled electronic unit. Operation: patient positioned via bite guide and headrest; motorized components rotate around patient head during exposure; X-ray beam collimated via slit diaphragm; secondary collimator blocks scattered radiation. Controlled by physician or dental technician via remote control box and handswitch. Microprocessor manages independent motors for projection geometry and technique factors. Output: radiographic film images used by clinicians for diagnostic assessment of dental structures. Benefits: provides diagnostic imaging for dental treatment planning.

Clinical Evidence

Evidence based on performance testing to meet product specifications, software design validation, hazard analysis, and clinical image exposures. No specific clinical trial metrics (e.g., sensitivity/specificity) provided.

Technological Characteristics

High-frequency inverter with DC output; microprocessor-controlled electronic unit; motorized rotation system; slit diaphragm collimation; 15x30cm film cassette; wall-mounted column; optional cephalometric arm. Software-controlled technique factors and projection geometry.

Indications for Use

Indicated for dental radiography as an extraoral source of x-rays for diagnostic imaging of the oral and maxillofacial region.

Regulatory Classification

Identification

An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

Predicate Devices

• Model PC-1000 (Panoramic Corporation of America)
• Versa View (J. Morita, USA Inc.)
• Cranex 2.5 + (Sorodex/Orion Corp.)
• GX-Pan (Gendex Dental X-Ray Div./Dentsply Int'l, Inc.)
• Orthoralix SD2/S (Gendex Dental X-Ray Div./Dentsply Int'l, Inc.)

Submission Summary (Full Text)

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## 510(k) Summary Statement for the
## Gendex Orthoralix E/GX-9000™ Panoramic Dental System

### I. General Information

**Submitter:** Gendex Dental X-Ray Division Dentsply International, Inc.
901 West Oakton St.
Des Plaines, IL 60018

**Telephone:** 847-640-4800 (company number)
847-640-4908 (contact person)

**FAX:** 847-640-4970

**Contact Person:** Daniel P. Murphy
(Director Engineering, Quality Assurance, & Regulatory Affairs)

**Summary Preparation Date:** November 13, 1996

### II. Names

**Device Name:** Orthoralix E/GX-9000™ Panoramic Dental System

**Primary Classification Name:** Extraoral Source X-Ray System (76 EHD)

### III. Predicate Devices

- Model PC-1000 marketed by Panoramic Corporation of America
- Versa View marketed by J. Morita, USA Inc.
- Cranex 2.5 + marketed by Sorodex/Orion Corp.
- GX-Pan marketed by Gendex Dental X-Ray Div./Dentsply Int'l, Inc.
- Orthoralix SD2/S marketed by Gendex Dental X-Ray Div./Dentsply Int'l, Inc.

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## IV. Product Description

The Dentsply/Gendex Orthoralix E/GX-9000™ is a high frequency panoramic x-ray system for radiographic diagnostic extraoral dental images. It is available in two models: standard pan and pan/ceph.

The Dentsply/Gendex Orthoralix E/GX-9000™ Panoramic X-Ray System is comprised of the following main components:

- High frequency inverter which supplies a true DC output and accurate technique factors
- A microprocessor controlled user-friendly electronic control unit which is cofigurable in six different languages
- A cloumn to be fixed to the wall
- Counter balanced overhead carriage with controls for patient positioning, setting of technique factors and radiographic projection geometry
- Cassette drive system with flat cassette for 15 x 30 cm film
- X-ray tubehead, with DC power supply via electronic converter
- Remote control box and handswitch
- Optional cephalometric arm and head positioner

During a panoramic exposure, the x-ray tube and cassette holder move around the patient’s head. The beam from the x-ray tube is collimated by a slit diaphragm. The flat film cassette passes behind a secondary collimator which blocks the radiation scattered from the patient.

Patient positioning is by means of a bite guide and a headrest. During exposure, the patient remains still while the motorized components rotate.

All movements for the panoramic radiographic projection are performed by two independent motors which are microprocessor controlled.

## V.A. Indications For Use/Rationale for Substantial Equivalence

The Orthoralix E/GX-9000™ Panoramic Dental X-Ray System is used as an extraoral source of x-rays in dental radiography.

It shares the same indications for use, similar materials, design, operational, and functional features and therefore is substantially equivalent to the predicate devices listed in section III of this summary.

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## V. Safety and Effectiveness Information

Safety and Effectiveness is demonstrated by:

- performance testing to meet product specifications
- software testing to validate software design/performance
- effective clinical image exposures
- hazard analysis including risk level and solutions
- same indications for use as predicate devices

All the above steps and evaluations combine to demonstrate that the Orthoralix E/GX-9000™ is safe and effective when the device is used as labeled.

## VI. Conclusion

The Orthoralix E/GX-9000™ Panoramic Dental X-Ray System was found to be substantially equivalent to the current marketed predicate devices: PC-1000; Versa View; Cranex 2.5 +; GX-Pan; and the Orthoralix SD2/S. The Orthoralix E/GX-9000™ share the same indications for use, similar materials, design, operational, and functional features as the current marketed predicate devices.

It has been shown to be safe and effective when the device is used as labeled.