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510(k) Data Aggregation
K Number
K231055Device Name
x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)
Manufacturer
de Götzen S.r.l.
Date Cleared
2023-12-28
(259 days)
Product Code
EHD
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
de Götzen S.r.l.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
x-mind dc (and Owandy-RX DC under trademark Owandy Radiology) is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral radiographic exams for diagnostic purposes related to anatomy of teeth and adjacent oral structures both on adult and pediatric patients, using specific x-ray detectors (chemical films, phosphor plates or digital xray sensors) that are not part of the device.
The device is operated and used by dentists, radiologists and other legally qualified health care professionals.
Device Description
x-mind dc consists of the following parts:
- 1 X-ray control unit (timer)
- 2 Wall plate and horizontal bracket
- 3 Pantograph type arm (scissor arm)
- 4 X-ray source assembly (tubehead)
- 5 Collimator cone (Beam Limiting Device)
The timer is the control panel used to manage the exposure settings and to safely use the tubehead. It allows easy and clear selection, with the help of clear and visible signals, of the exposure settings, perform personal settings and display alarms of the device in case of incorrect operation or eventual failures.
The horizontal bracket it is available in 3 different lengths and represents the support for the scissor arm. The pantograph arm, being adjustable in height and depth, allows the precise positioning of the tubehead. The tubehead of the device contains the X-ray tube, the high voltage board and the high frequency generator. It is the component of the device which emits the X-rays.
The collimator cone represents the part of the device in contact with the patient and it allows the correct focal spot to skin distance, ensures the dimension, direction and centering of the X-ray beam.
x-mind dc can be used with conventional chemical films (D, E, F speed films), phosphor plates (PSP), RVG digital detectors (CCD or CMOS).
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K Number
K203374Device Name
X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)
Manufacturer
de Götzen S.r.l.
Date Cleared
2021-02-05
(81 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
de Götzen S.r.l.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
X-MIND prime (and I-MAX under trade mark Owandy Radiology) is an extra-oral dental panoramic X-ray unit to take two dimensional radiographic exams of teeth, jaw and oral structures (panoramic, TMI and sinus exams). The models with cephalometric arm will be able to take two dimensional cranial cephalometric exams in different projections and the wrist exam (Carpus) dedicated to the evaluation of the bone growth. The device is operated and used by dentists, radiologists and other legally qualified health care professionals, i.e. Prescription Use (Part 21 CFR 801 Subpart D). The target patient population includes adults and pediatric patients from 7 years old [~27 kg (59.5 lb); 125 cm (49.2 in) standing height].
Device Description
X-MIND prime is an X-ray device for the radiographic analysis of the maxillo-facial complex.
X-MIND prime performs Panoramic, Half-panoramic, Low dose Panoramic, Frontal dentition, Ortho Rad Panoramic, Bitewing Bilateral, Bitewing Right, Sinus, TMJ, AP and LL cephalometric exams, Carpus exam.
X-MIND prime system can be used with the following type of patient:
- Patient population: the target patient population includes adults and pediatric patients from 7 . years old [~25 kg (55 lb); 125 cm (49.2 in) standing height]. Anyway, the sustainability to X-ray exposure must be evaluated by surgeons, dentists and qualified and authorized physicians
- . Patient status:
- . self-sufficient patient (the patient can autonomously place himself as requested by the physician)
- non self-sufficient patient (the patient is assisted by medical personnel) .
- in any case the patient must be conscious, not anaesthetized and not incapacitated ・
- . Nationality: multiple.
X-MIND prime device consists of the following parts: Control panel, Detector group, Fixed arm, Telescopic Column, Patient handgrip, Patient support, X-ray generator, Rotating arm, CEPH arm (optional), CEPH craniostat (optional), CEPH 2ry collimator (optional), Detector (optional).
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