(33 days)
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No
The description focuses on the mechanical and electronic components of a standard panoramic x-ray system, with no mention of AI or ML capabilities for image processing, analysis, or other functions. The control is described as microprocessor-controlled, which is typical for such devices and does not imply AI/ML.
No
The device is described as an "extraoral source of x-rays in dental radiography" and used for "radiographic diagnostic extraoral dental images," indicating it is an imaging device for diagnosis, not for therapy.
Yes
The device is described as "a high frequency panoramic x-ray system for radiographic diagnostic extraoral dental images," explicitly stating its role in generating images for diagnosis.
No
The device description clearly outlines numerous hardware components including an x-ray tubehead, cassette drive system, motors, and a physical column, indicating it is a hardware-based system with software control.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as an extraoral source of x-rays in dental radiography." This describes a device used to generate images of the inside of the body, not a device used to examine specimens taken from the body (which is what "in vitro" means).
- Device Description: The description details an X-ray system that takes images of the patient's head and teeth. This is consistent with an imaging device, not an IVD.
- Anatomical Site: The anatomical site is "Dental," which further supports its use for imaging the patient directly.
IVD devices are used to examine specimens such as blood, urine, or tissue outside of the body to diagnose diseases or conditions. This device is clearly used for imaging the patient directly.
N/A
Intended Use / Indications for Use
The Orthoralix E/GX-9000™ Panoramic Dental X-Ray System is used as an extraoral source of x-rays in dental radiography.
Product codes
EHD
Device 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
x-ray
Anatomical Site
Dental
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
K 964659
PI93
DEC 2 3 1996
Tab 23
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 Prenaration 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.
1
1.964659 P293
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.
2
K964659
p3093
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.