(94 days)
Not Found
No
The 510(k) summary describes a standard panoramic dental X-ray system with no mention of AI or ML in the device description, intended use, or any other section. The focus is on the hardware and basic image acquisition process.
No.
The device is used for imaging, specifically producing panoramic-ray images for examination, which is a diagnostic function, not a therapeutic one.
Yes
The device produces panoramic X-ray images of the maxillofacial region to examine teeth, the jaw, and oral structures, which are used for diagnostic purposes by a clinician.
No
The device description clearly outlines physical hardware components including an X-ray source, detector, console, and patient positioning system, indicating it is a hardware-based medical device.
Based on the provided information, the Cefla MyRay Hyperion is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The MyRay Hyperion is used to produce images of the maxillofacial region directly from the patient using X-rays. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The intended use is for diagnostic imaging. The device is used to create images for the examination of teeth, jaw, and oral structures. This is a form of in vivo (within the living body) diagnostic imaging, not in vitro (in glass, or outside the living body) diagnostics.
The description clearly indicates it's an X-ray system for capturing images of the patient's anatomy.
N/A
Intended Use / Indications for Use
The Cefla MyRay Hyperion is intended for use in producing panoramic-ray images of the maxillofacial region. It is used for the examination of teeth, the jaw, and oral structures.
Product codes
MUH
Device Description
The MyRay Hyperion is a panoramic dental X-ray system which consists of a telescopic column, an overhead frame with a horizontal arm where an X-ray source and collimator and an X-ray image detector are mounted, and a console with a keyboard and display. The device includes a patient positioning system that consists of two handles which the patient grasps during exposures, a bite block, a frame for holding the head in the proper position and alignment with laser guide lights. The x-ray source and collimator generate a fan shaped x-ray beam which is projected through the patient's skull by the rotation of the imaging unit. The x-ray image detector allows reconstruction of the diagnostic image, storage of the image in the buffer memory, and transfer of the image to an external PC (not provided by Cefla).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
maxillofacial region (teeth, jaw, and oral structures)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Instrumentarium Dental Inc., Orthopantomograph OP200D (K043612), Sirona Dental System GmbH, Orthophos XG DS (K033073), Gendex, Orthoralix 9200 DDE (K032355)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary for the Cefla, s.c. - Cefla Dental Group Cefla MyRay Hyperion
1101661
1. SPONSOR
SEP 1 G 2010
Cefla, s.c. - Cefla Dental Group via Selice Prov. le 23/a Imola, BO 40026 Italy
| Contact: | Simona Daidone | |
|---|---|---|
| Telephone: | +39 0542 653111 |
Date Prepared: June 11, 2010
2. DEVICE NAME
Proprietary Name: Common/Usual Name: Classification Name:
MyRay Hyperion Dental Panoramic X-ray system System, x-ray, extraoral, source, digital
3. PREDICATE DEVICES
- · Instrumentarium Dental Inc., Orthopantomograph OP200D (K043612)
- Sirona Dental System GmbH, Orthophos XG DS (K033073) .
- Gendex, Orthoralix 9200 DDE (K032355) .
4. INTENDED USE
The Cefla MyRay Hyperion is intended for use in producing panoramic-ray images of the maxillofacial region. It is used for the examination of teeth, the jaw, and oral structures.
5. DEVICE DESCRIPTION
The MyRay Hyperion is a panoramic dental X-ray system which consists of a telescopic column, an overhead frame with a horizontal arm where an X-ray source and collimator and an X-ray image detector are mounted, and a console with a keyboard and display. The device includes a patient positioning system that consists of two handles which the patient grasps during exposures, a bite block, a frame for holding the head in the proper position and alignment with laser guide lights. The x-ray source and collimator generate a fan shaped x-ray beam which is projected through the patient's skull by the rotation of the
1
imaging unit. The x-ray image detector allows reconstruction of the diagnostic image, storage of the image in the buffer memory, and transfer of the image to an external PC (not provided by Cefla). A detailed description of the components is provided below.
Telescopic Column
The telescopic column supports the patient arm at which the patient stands during X-ray exposures. It also includes the patient handles which the patient holds during imaging and a plate which contains the mid-sagittal laser beam, the bite block and chin rest. The telescopic column allows adjustment of the patient arm to the patient's height.
Overhead Assembly
The overhead assembly supports the main horizontal and rotating arm. The rotating arm holds the x-ray generator and the collimator in a fixed position opposite to the x-ray image detector.
Console
The console allows the user to select the projection mode and the exposure factors, view the machine status information, control the height of the telescopic column, adjust the reset of the Y-axis, and turn on the laser guide lights. A system emergency stop button is included on the console so the user can immediately stop the procedure.
Control Panel
The control panel serves as the user interface with the electronic control system. The layout of the controls has been designed to split the panel into 2 sections. The "Procedure programming" area is found on the left side from which the user selects the type of procedure to be performed and technical settings. The "Assisted positioning" area is found on the right side of the panel which contains the controls to move the unit to position the patient. In addition, a port for an SD card (Secure Digital Memory Card) is provided at the bottom of the control panel. If this card is inserted, the images can be saved without having to connect the unit to a computer.
Control System
The electronic components which control the system operation consist of the following:
- · Main unit- providing real-time system control as well as motor drive;
- · Power unit- connecting to the mains power supply and providing the 400 VDC bus for the system;
- · Converter unit- controlling the power to the x-ray generator;
2
- · Sensor unit- controlling the x-ray image detector
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The Cefla MyRay Hyperion dental x-ray system is similar in design and materials to the Instrumentarium OP200D, subject of K043612, the Sirona Orthophos XG DS, subject of K033073, and the Gendex Orthoralix 9200 DDE subject of K032355. The similarities in intended use, operational characteristics, and functional technological characteristics between the MyRay Hyperion, OP 200D, and Orthophos XG DS dental x-ray systems lead to a conclusion of substantial equivalence between the proposed and predicate devices. A comparison between the features of the proposed device and those of the predicate devices is shown in Table 5-1 below:
| Comparison Chart | Hyperion | Instrumentarium OP
200 D | Sirona
Orthophos XG 5 | Gendex
Orthoralix 9200 |
|------------------------------------|---------------------------------------------------|---------------------------------------------------|---------------------------------------------------|---------------------------------------------------|
| Maximum total weight | 145 kg | 175 kg | 183 kg | 115-212 kg |
| Nominal voltage | 230/115 VAC | 230/115 VAC | 230/115 VAC | 250-115 VAC |
| Nominal frequency | 60 Hz | 60 Hz | 60 Hz | 60 Hz |
| X-ray source: geometry
and type | Fan beam, High
Frequency
Constant Potential | Fan beam, High
Frequency Constant
Potential | Fan beam, High
Frequency
Constant Potential | Fan beam, High
Frequency
Constant Potential |
| X-ray source: focal spot | 0.5mm | 0.5mm | 0.5mm | 0.5 mm |
| X-ray source: max.
energy | 85 kVp | 85 kVp | 90 kVp | 84 kVp |
| Exposure Time (std.
panoramic) | 9.3 s | 17.6 s | 14.2 s | 12 s |
| Patient position | Lateral | Frontal | Frontal | Frontal |
| Detector: type | CCD | CCD | CCD | CCD |
| CCD pixel size | 48 microns | 48 microns | 27 microns | 48 microns |
| Detector area | 147 x 6 mm | 147 x 6 mm | N.A. | 147 x 6 mm |
| Detector: gray scale | 12 bit | 12 bit | 16 bit | 12 bit |
| Image pixel size | 96 x 96 microns | 96 x 96 microns | N.A. | 96 x 96 microns |
| Computer interface | LAN | Proprietary (PCI slot) | LAN | LAN |
| Patient positioning | 3 laser lines | 3 laser lines | 2 laser lines | 3 laser lines |
Table 5-1. Comparison Table for Determination of Substantial Equivalence
NA=Not available, LAN=Local area network, PCI=Personal Computer Instrumentation
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or supporting three wavy lines, which may represent people or services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Cefla Dental Group % Ms. Mary McNamara-Cullinane Senior Regulatory Consultant Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760
SEP 1 6 2010
Re: K101661
Trade/Device Name: Cefla MyRay Hyperion Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: June 11, 2010 Received: June 14, 2010
Dear Ms. McNamara-Cullinane:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 220). This letter will allow you to begin marketing your device as described in your Section 5100%) premarket. notification. The FDA finding of substantial equivalence of your device to a legal y renatisted 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Donald J. Trump
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K161661
Device Name:
Cefla MyRay Hyperion
SEP 1 6 2010
i
Indications for Use:
The Cefla MyRay Hyperion is indicated for use in producing panoramic X-ray images of the maxillofacial region. It is used for the examination of teeth, the jaw, and oral structures.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (00) C
Division Sign Only
ion Sian-O Division of Radiological Dev Office of In Vitro Diagnostic Device Eva
510K KIOKIOI