(57 days)
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No
The description focuses on the mechanical and electronic components of a traditional digital X-ray system, with no mention of AI or ML for image processing, analysis, or other functions. The control is described as microprocessor-controlled, which is standard for such devices and does not imply AI/ML.
No.
The device is described as an "extraoral source of x-rays for imaging of the dentomaxilofacial area," indicating its purpose is for diagnosis through imaging, not for treatment.
Yes
The device is described as an "extraoral source of x-rays for imaging of the dentomaxilofacial area," indicating its purpose is to create images that can be used for diagnosis.
No
The device description explicitly lists multiple hardware components, including an X-ray tubehead, motorized column, and cassette drive system, indicating it is a hardware-based medical device with integrated software.
Based on the provided information, 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 for imaging of the dentomaxilofacial area." This describes a device used to create images of the body, not to examine specimens derived from the body (like blood, urine, or tissue) to provide information about a physiological state, health, or disease.
- Device Description: The description details an X-ray system with components like an X-ray tubehead, cassette drive, and positioning mechanisms. This aligns with an imaging device, not a device for analyzing biological samples.
- Input Imaging Modality: The input is X-ray, which is an imaging modality used to visualize internal structures of the body. IVDs typically involve analyzing chemical, biological, or immunological properties of samples.
- Anatomical Site: The anatomical site is the "dento-maxilofacial area," which is a part of the human body being imaged. IVDs analyze samples taken from the body.
In summary, the Orthoralix 9200 DDE is a medical imaging device used to produce images of the dentomaxilofacial area using X-rays. This falls under the category of diagnostic imaging, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Orthoralix 9200 DDE Digital Panoramic and Cephalometric Dental X-Ray System is to be used as an extraoral source of x-rays for imaging of the dento-maxilofacial area.
Product codes (comma separated list FDA assigned to the subject device)
76EHD, 90 EHD
Device Description
The DENTSPLY International, Gendex Division Orthoralix 9200 DDE Digital Panoramic and Cephalometric Dental X-Ray System is an extraoral source of x-rays for imaging of the dentomaxilofacial area.
The DENTSPLY International, Gendex Division Orthoralix 9200 DDE Digital Panoramic and Cephalometric Dental 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 .
- A motorized column to be fixed to the wall ●
- Counter balanced overhead carriage with controls for patient positioning, setting and control . of technique factors and radiographic projection geometry
- Cassette drive system with flat cassette for 15x30 cm film
- X-ray tubehead, with DC power supply via electronic converter .
- Remote control box and handswitch
- . Optional cephalometric arm and head postioner
- Optional utilities for transverse scanography of the jaw ("Transcan®") ●
During a panoramic exposure, the x-ray tube and cassette holder moves 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 four 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-rays
Anatomical Site
dentomaxilofacial area
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
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 -
- Risk analysis including risk level and solution -
- 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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
SEP 2 5 2003
Image /page/0/Picture/2 description: The image shows the logos for Dentsply and Gendex. The Dentsply logo is in a bold, sans-serif font, with the letters closely spaced together. Below Dentsply is the Gendex logo, which is in a thinner, sans-serif font. Both logos are in black and are stacked vertically.
man mana
DENTSPLY International Gendex Division 901 West Oakton Street Des Plaines, IL 60018-1884 Phone (847) 640-4800 Fax (847) 640-4970
510(k) Summary Statement for the Gendex Orthoralix 9200 DDE Digital Panoramic and Cephalometric Dental X-Ray System
I. General Information
| Submitter: | DENTSPLY International
Gendex Division
901 West Oakton St.
Des Plaines, IL 60018 |
|---------------------------|-------------------------------------------------------------------------------------------|
| Telephone: | (847) 640-4800 - Company Number
(847) 640-4924 - Contact Person |
| Fax: | (847) 640-4970 |
| Contact Person: | John R. Miller
Director, Quality Assurance and Regulatory Affairs |
| Summary Preparation Date: | June 30, 2003 |
II. Names
| Device Name: | Orthoralix 9200 DDE Digital Panoramic and Cephalometric
Dental X-Ray System |
|------------------------------|--------------------------------------------------------------------------------|
| Primary Classification Name: | 76EHD – Unit, X-Ray, Extraoral with Timer |
III. Predicate Devices
- Gendex Orthoralix 9200 and 9200 Plus
- Instrumentarium Orthoceph® OC100 D Direct Digital Cephalometric Imaging System ●
- Planmeca DIMAX2 Direct Digital Imaging System
- . Sirona Orthophos Plus DS
1
Orthoralix 9200 DDE Summary Statement Page 2 of 3
IV. Product Description
The DENTSPLY International, Gendex Division Orthoralix 9200 DDE Digital Panoramic and Cephalometric Dental X-Ray System is an extraoral source of x-rays for imaging of the dentomaxilofacial area.
The DENTSPLY International, Gendex Division Orthoralix 9200 DDE Digital Panoramic and Cephalometric Dental 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 .
- A motorized column to be fixed to the wall ●
- Counter balanced overhead carriage with controls for patient positioning, setting and control . of technique factors and radiographic projection geometry
- Cassette drive system with flat cassette for 15x30 cm film
- X-ray tubehead, with DC power supply via electronic converter .
- Remote control box and handswitch
- . Optional cephalometric arm and head postioner
- Optional utilities for transverse scanography of the jaw ("Transcan®") ●
During a panoramic exposure, the x-ray tube and cassette holder moves 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 four independent motors, which are microprocessor controlled.
V. Indications for Use/Rationale for Substantial Equivalence
The Orthoralix 9200 DDE Digital Panoramic and Cephalometric Dental X-Ray System is to be used as an extraoral source of x-rays for imaging of the dento-maxilofacial area.
It shares the same indications for use, similar materials, design, operations, and functional features and therefore is substantially equivalent to the predicate devices listed in Section III of this summary.
VI. 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 -
- Risk analysis including risk level and solution -
- Same indications for use as predicate devices. ..
2
Orthoralix 9200 DDE Summary Statement Page 3 of 3
All the above steps and evaluations combine to demonstrate that the Orthoralix 9200 DDE Digital Panoramic and Cephalometric Dental X-Ray System is safe and effective when the device is used as labeled
VII. Conclusion
The DENTSPLY International, Gendex Division Orthoralix 9200 DDE Digital Panoramic and Cephalometric Dental X-Ray System was found to be substantially equivalent to the predicate devices, the Gendex Orthoralix 9200 and 9200 Plus, the Instrumentarium Orthoceph® OC100 D Direct Digital Cephalometric Imaging System, the Planmeca DIMAX2 Direct Digital Imaging System, and the Sirona Orthophos Plus DS. The DENTSPLY International, Gendex Division Orthoralix 9200 DDE Digital Panoramic and Cephalometric Dental X-Ray System shares 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 used as labeled.
3
Image /page/3/Picture/1 description: The image shows a black and white logo. The logo is circular in shape and features a stylized image of an eagle in flight. The eagle is facing to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 5 2003
Mr. John R. Miller Director DENTSPLY International Gendex Division 901 West Oakton Street DES PLAINES IL 60018-1884 Re: K032355
Trade/Device Name: Orthoralix 9200 Panoramic and Cephalometric Dental X-Ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 EHD Dated: July 21, 2003 Received: July 30, 2003
Dear Mr. Miller:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
4
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
8xx. 1xxx | (301) 594-4591 |
---|---|
876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Nancy C. Brygdon
Nancy C. B rogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): Not Assigned
Orthoralix 9200 DDE Digital Panoramic and Cephalometric Device Name: Dental X-Ray System
Indications for Use:
The Orthoralix 9200 DDE Digital Panoramic and Cephalometric Dental X-Ray System is to be used as an extraoral source of x-rays for imaging of the dentomaxilofacial area.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David R. deymm
(Division Sign-Off Division of Reproductive, Abdominal and Radiological Device 510(k) Number
Prescription Use
(Per 21CFR 801.109)
OR
Over-The-Counter Use __
(Optional Format 1-2-96)
Image /page/5/Picture/13 description: The image shows the number 000046 in a bold, sans-serif font. The numbers are black against a white background. The numbers are evenly spaced and aligned horizontally. The number is likely a serial number or some other type of identification number.