(81 days)
No
The description focuses on digital subtraction and image processing techniques, with no mention of AI or ML. The performance studies describe a "warping algorithm" for image registration, which is a standard image processing technique, not necessarily AI/ML.
No.
The device digitizes and processes dental radiographs for analysis, it does not provide any treatment or therapy. Its function is diagnostic.
Yes
The device "is helpful in the detection of hard tissue changes including pathologies as well as resolution of those same pathologies," indicating its use in diagnosing conditions.
No
The device description explicitly states that the RAD System consists of a high resolution digital image scanner and the RADy software program, indicating it includes hardware components in addition to software.
Based on the provided information, the RAD& System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- RAD& System Function: The RAD& System processes dental radiographs (X-rays), which are images of the internal structures of the body. It does not analyze biological samples taken from the body.
- Intended Use: The intended use is for longitudinal radiographic analysis to detect hard tissue changes in the mouth, which is a diagnostic process based on imaging, not on the analysis of biological specimens.
Therefore, the RAD& System falls under the category of a medical imaging device rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The RAD& 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.
Product codes
Not Found
Device Description
The RAD 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.
The RAD System consists of a high resolution digital image scanner and the RADy software program. Also required are an IBM compatible personal computer, a long cone, and a parallel aiming system. The ability of the RADx 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic images
Anatomical Site
Dental
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental practitioner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The design of the RAD 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. The testing of the RAD, System demonstrates that the performance is substantially equivalent to predicate devices cited above.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.1800 Extraoral source x-ray system.
(a)
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.(b)
Classification. Class II.
0
MAR 1 7 1997
510(K) SUMMARY FOR ELECTRO MEDICAL SYSTEMS RAD, SYSTEM
DATE THIS SUMMARY WAS PREPARED 1.
December 24, 1996
SUBMITTER'S NAME AND ADDRESS 2.
Electro Medical Systems 670 International Parkway, Suite 100 Richardson, TX 75081
CONTACT PERSON 3.
Ms. Kathryn Hamilton Electro Medical Systems Telephone (972)690-8382 Facsimile (972)690-8981
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.
DEVICE DESCRIPTION 6.
The RAD 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.
1
The RAD System consists of a high resolution digital image scanner and the RADy software program.
Also required are an IBM compatible personal computer, a long cone, and a parallel aiming system.
The ability of the RADx 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.
INTENDED USE 7.
The RAD& 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.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS 8.
The EMS RAD& 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 wellaccepted technique of digital image subtraction.
9. NONCLINICAL TESTS USED IN DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The design of the RAD 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 RAD, System demonstrates that the performance is substantially equivalent to predicate devices cited above.