Search Results
Found 1 results
510(k) Data Aggregation
K Number
K032355Device Name
ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105 0181WW
Manufacturer
DENTSPLY GENDEX
Date Cleared
2003-09-25
(57 days)
Product Code
EHD
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
DENTSPLY GENDEX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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.
Ask a Question
Page 1 of 1