RADX SYSTEM

K965203 · Electro Medical Systems, Inc. · EHD · Mar 17, 1997 · Dental

Device Facts

• Record ID: K965203
• Device Name: RADX SYSTEM
• Applicant: Electro Medical Systems, Inc.
• Product Code: EHD · Dental
• Decision Date: Mar 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The RADₓ System digitizes and processes dental radiographs to perform longitudinal radiographic analysis using the digital subtraction technique. This technique is helpful in the detection of hard tissue changes including pathologies as well as resolution of those same pathologies.

Device Story

RADₓ System enables longitudinal dental radiographic analysis; inputs: series of dental X-rays taken via long-cone paralleling technique; process: high-resolution digital image scanner digitizes X-rays; software performs digital subtraction analysis to detect bone density changes; output: spatially registered images for comparison; used in dental clinics by practitioners; benefits: detects small bone density changes and pathologies without requiring rigid projection geometry; aids clinical diagnosis of hard tissue changes.

Clinical Evidence

Bench testing only. Validation of software design and scanner suitability for X-ray digitization. Verification that warping algorithm reduces registration error to levels within ranges reported in literature for manual registration and alignment stent/long source-to-object projection techniques.

Technological Characteristics

System includes high-resolution digital image scanner, RADₓ software, IBM-compatible PC, long cone, and parallel aiming system. Employs digital subtraction radiography. Software utilizes warping algorithm for image registration.

Indications for Use

Indicated for dental practitioners to perform longitudinal radiographic analysis of dental radiographs to detect hard tissue changes and pathologies.

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

• DXS Digital Subtraction Radiography Image Processor (K914376)

Submission Summary (Full Text)

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K965203

MAR 17 1997

# 510(K) SUMMARY FOR ELECTRO MEDICAL SYSTEMS
## RADₓ SYSTEM

1. DATE THIS SUMMARY WAS PREPARED
December 24, 1996

2. SUBMITTER'S NAME AND ADDRESS
Electro Medical Systems
670 International Parkway, Suite 100
Richardson, TX 75081

3. CONTACT PERSON
Ms. Kathryn Hamilton
Electro Medical Systems
Telephone [phone]
Facsimile [phone]

4. DEVICE NAME
Trade/Proprietary Name: RADₓ System
Common Name: Longitudinal Radiographic Analysis System
Classification Name: Accessory to Stationary X-ray Systems

5. PREDICATE DEVICES
The legally marketed device to which equivalence is being claimed is the DXS Digital Subtraction Radiography Image Processor manufactured by Picker International which was cleared under premarket notification K914376.

6. DEVICE DESCRIPTION
The RADₓ System enables the dental practitioner to take a longitudinal series of X-rays using the long-cone paralleling technique, digitize the resulting images, and perform digital subtraction analysis to detect very small changes in bone densities.

Electro Medical Systems RADₓ System 510(k) 12/24/96 Page D-1

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The $\mathrm{RAD}_{\mathbf{x}}$ System consists of a high resolution digital image scanner and the $\mathrm{RAD}_{\mathbf{x}}$ software program.

Also required are an IBM compatible personal computer, a long cone, and a parallel aiming system.

The ability of the $\mathrm{RAD}_{\mathbf{x}}$ System to create spatially registered images for comparison without the use of rigid projection geometry allows longitudinal radiographic analysis using equipment readily available to the average dental practitioner.

## 7. INTENDED USE

The $\mathrm{RAD}_{\mathbf{x}}$ System digitizes and processes dental radiographs to perform longitudinal radiographic analysis using the digital subtraction technique. This technique is helpful in the detection of hard tissue changes including pathologies as well as resolution of those same pathologies.

## 8. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The EMS $\mathrm{RAD}_{\mathbf{x}}$ System and the Picker International DXS System are both intended for digitizing, storing, and performing digital image subtraction analysis on radiographic images. Both systems aid the practitioner in recognizing certain features and making certain diagnoses using the well-accepted technique of digital image subtraction.

## 9. NONCLINICAL TESTS USED IN DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The design of the $\mathrm{RAD}_{\mathbf{x}}$ software has been thoroughly validated and documented. Non-clinical tests were conducted to evaluate the suitability of commercially available scanners for digitizing x-rays and to verify that the warping algorithm reduces registration error to a level that is well within the range reported in the literature for accepted manual registration methods and either alignment stent or long source-to-object projection techniques.

## 10. CONCLUSIONS FROM NONCLINICAL TESTING

The testing of the $\mathrm{RAD}_{\mathbf{x}}$ System demonstrates that the performance is substantially equivalent to predicate devices cited above.

Electro Medical Systems $\mathrm{RAD}_{\mathbf{x}}$ System 510(k) 12/24/96