(85 days)
Pelton & Crane Orthophos Plus, Instrumentarium Imaging Orthorpantomograph® OPD, Planmeca PM 2002 CC Proline, Gendex Orthoralix SD2/Ceph & S/Ceph
Not Found
No
The description focuses on the mechanical and electronic components of a standard dental X-ray system, with no mention of AI or ML for image processing, analysis, or control. The microprocessor control is for motor movements, not AI/ML functions.
No
The device is an extraoral source of x-rays for imaging of the dento-maxilofacial area, designed for diagnostic purposes rather than therapeutic treatment.
Yes
The device is described as an "extraoral source of x-rays for imaging of the dento-maxilofacial area," which is used to produce images that are then used for diagnosis of conditions within that anatomical region.
No
The device description explicitly lists multiple hardware components, including an x-ray tubehead, motorized column, cassette drive system, and control electronics.
Based on the provided information, this device 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.
- Device Function: The Orthoralix 9200 is an X-ray system used to create images of the dento-maxilofacial area. It is an imaging device that uses external radiation to visualize internal structures.
- Intended Use: The intended use clearly states it is for "imaging of the dento-maxilofacial area" using an "extraoral source of x-rays." This involves taking pictures, not analyzing biological samples.
Therefore, the function and intended use of this device fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Orthoralix 9200 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
Device Description
The Dentsply/Gendex Orthoralix 9200 Panoramic and Cephalometric Dental X-Ray System is an extraoral source of x-rays for imaging of the dento-maxilofacial area.
The Dentsply/Gendex Orthoralix 9200 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 positioner ●
- 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-rays
Anatomical Site
dento-maxilofacial area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
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 solution ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
- Same indications for use as predicate devices. -
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Pelton & Crane Orthophos Plus, Instrumentarium Imaging Orthorpantomograph® OPD, Planmeca PM 2002 CC Proline, Gendex Orthoralix SD2/Ceph & S/Ceph
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.
Not Found
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
Image /page/0/Picture/2 description: The image shows the logos of two companies, Dentsply and Gendex, stacked vertically. The Dentsply logo is in a bold, sans-serif font with a unique, stylized 'P'. Below it, the Gendex logo is in a simpler, rounded sans-serif font. Both logos are in black and white.
GENDEX Dental X-Ray Division Dentsply International Inc. 901 West Oakton Street Des Plaines, IL 60018-1884 Phone (847) 640-4800 (847) 640-4970 FAX
510(k) Summary Statement for the Gendex Orthoralix 9200 Panoramic and Cephalometric Dental X-Ray System
- I General Information
| Submitter: | Gendex Dental X-Ray Division of Dentsply International, Inc
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: | William T. Cousins
Area Manager Quality Assurance and Regulatory Affairs |
| Summary Preparation Date: December 14, 1999 | |
II Names
Device Name: Orthoralix 9200 Panoramic and Cephalometric Dental X-Ray System
Primary Classification Name: 76EHD - Unit, X-Ray, Extraoral with Timer
III Predicate Devices
- . Pelton & Crane Orthophos Plus
- Instrumentarium Imaging Orthorpantomograph® OPD ●
- Planmeca PM 2002 CC Proline
- Gendex Orthoralix SD2/Ceph & S/Ceph .
1
IV Product Description
The Dentsply/Gendex Orthoralix 9200 Panoramic and Cephalometric Dental X-Ray System is an extraoral source of x-rays for imaging of the dento-maxilofacial area.
The Dentsply/Gendex Orthoralix 9200 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 positioner ●
- 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 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, operational, and functional features and therefore is substantially equivalent to the predicate devices listed in section III of this summary.
2
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 -
- Hazard analysis including risk level and solution ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
- Same indications for use as predicate devices. -
All the above steps and evaluations combine to demonstrate that the Orthoralix 9200 Panoramic and Cephalometric Dental X-Ray System is safe and effective when the device is used as labeled.
VII Conclusion
The Gendex Orthoralix 9200 Panoramic and Cephalometric Dental X-Ray System was found to be is Substantially Equivalent to the predicate devices; the Pelton & Crane Orthophos Plus, the Planmeca PM 2002 CC Proline, the Instrumentarium Imaging Orthorpantomograph® OPD, and the Gendex Orthoralix SD2/Ceph and S/Ceph. The Gendex Orthoralix 9200 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 the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 4 2000
William T. Cousins Area Manager, Quality Assurance and Regulatory Affairs GENDEX Dental X-Ray Division Dentsply International, Inc. 901 West Oakton Street Des Plaines, IL 60018-1884
Re: -K994285
Orthoralix 9200 (Panoramic and Cephalometric Dental X-Ray System Dated: December 14, 1999 Received: December 20, 1999 Regulatory class: II 21 CFR 872.1800/Procode: 76 EHD
Dear Mr. Cousins:
We have reviewed your Section 510(k) notification of intent to market the device and we 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 pror 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). 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 and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notfication submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-5597 or at its internet address "http://www.fda.gov/odrh/dsmaldsmamain.html".
Sincerely yours,
Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
4
510(k) Number (if known): Not Assigned
Device Name:
Orthoralix 9200 Panoramic and Cephalometric Dental X-Ray System
Indications for Use:
The Orthoralix 9200 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stamil C. Ingram
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiological Devi 510(k) Number .
Prescription Use (Per 21CFR 801.109)
OR
Over-The-Counter Use _
(Optional Format 1-2-96)