X-MIND trium

K160166 · De Gotzen S.R.L. · OAS · Nov 15, 2016 · Radiology

Device Facts

• Record ID: K160166
• Device Name: X-MIND trium
• Applicant: De Gotzen S.R.L.
• Product Code: OAS · Radiology
• Decision Date: Nov 15, 2016
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

X-MIND trium is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, indicated for use in - producing panoramic X-ray images for diagnostic examination of dentition (teeth), jaws and oral structures; - producing radiographs of maxillofacial region and parts of the skull for cephalometric exammation, if equipped with CEPH arm: - producing radiographs of hands and wrists for carpus examination, if equipped with CEPH arm: - producing tomographic mages of the oral and maxillofacial region, for diagnostic examination of dentition (teeth), aws. oral structures and some cranial bones, if equipped with CBCT option.

Device Story

X-MIND trium is a digital extra-oral X-ray system for panoramic, cephalometric, and CBCT imaging. It uses an X-ray generator with an automatic collimator and a rotating U-arm to acquire images of the maxillofacial region. The system includes a patient support, head immobilization accessories, and an operator workstation running ACTEON Imaging Suite (AIS) software. The operator controls exposure via a remote switch. The device is used in dental clinics and hospitals by trained professionals. Output images are visualized and processed on the workstation for diagnostic purposes, including dental implant planning, surgery, and cephalometric analysis. The device benefits patients by providing diagnostic imaging for various dental and maxillofacial conditions.

Clinical Evidence

Bench testing only. Performance evaluated per FDA guidance for solid-state X-ray imaging devices. Metrics included image homogeneity, artifacts, low/high contrast spatial resolution, CNR, MTF, Nyquist frequency, voxel noise, and NPS. Radiation dose (DAP) was compared against NCRP Report No. 172 DRLs. Results demonstrated equivalent image quality and safety profiles to the predicate.

Technological Characteristics

Digital X-ray system; CMOS detectors (Hamamatsu); X-ray tube (CEI OPX/105); 60-90 kV range; 4-12 mA range; 0.5 mm focal spot; aluminum/copper filtration. Connectivity via Ethernet to workstation. Standards: IEC 60601-1 (3rd ed.), IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-63, IEC 60601-1-6, IEC 62366, ISO 14971.

Indications for Use

Indicated for adults and pediatric patients from 5 years old (~21 kg; 113 cm standing height) for panoramic, cephalometric, and CBCT imaging of dentition, jaws, oral structures, maxillofacial region, and carpus. Sustainability to X-ray exposure must be evaluated by qualified physicians, surgeons, or dentists.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Hyperion X9 (K123381)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles connected by flowing lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 15, 2016

de Götzen S.r.l. % Mr. Olivier Balouka Legal Representative Via Roma, 45 Olgiate Olona, Varese 21057 ITALY

Re: K160166 Trade/Device Name: X-MIND trium Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS, MUH Dated: October 14, 2016 Received: October 26, 2016

Dear Mr. Balouka:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D.'Hara

For

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

### K160166

Device Name X-MIND trium

Indications for Use (Describe)

X-MIND trium is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, indicated for use in - producing panoramic X-ray images for diagnostic examination of dentition (teeth), jaws and oral structures;

- producing radiographs of maxillofacial region and parts of the skull for cephalometric exammation, if equipped with CEPH arm:

- producing radiographs of hands and wrists for carpus examination, if equipped with CEPH arm:

- producing tomographic mages of the oral and maxillofacial region, for diagnostic examination of dentition (teeth), aws. oral structures and some cranial bones, if equipped with CBCT option.

From a clinical point of view, the X-MIND trium can be applied for the following medical applications:

- · Generic dentistry
- · Dental implantology
- · Dental surgery
- · Maxillo-facial surgery
- · Cephalometric analysis
- · Carpus radiology

The intended population can be whatever, including pediatric patients from 5 years old [~21 kg (46 lb); 113 cm (44.5 in) standing height]; anyway the sustainability to X-ray exposure must be evaluated by qualified and authorized physicians, surgeons and dentists.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: This image is a table with three columns. The first column contains the logo for ACTEON, the address Via Roma, 45, and the city 21057 Olgiate Olona (VA). The second column contains the text X-MIND trium and 510 (k) Summary. The third column contains the text 510 (k) submission Section 5, Ed. 3.0, and Of October 3rd, 2016.

# 510 (k) Summary

The summary of this 510(k) is being submitted in accordance with the requirements of 21 CFR Part 807.92.

## I. SUBMITTER

| Owner's name: | de Götzen S.r.l. – ACTEON Group |
|-----------------|------------------------------------------------------------------------------------------------------|
| Address: | via Roma, 45 – 21057 Olgiate Olona (VA), Italy |
| Tel. | [phone] |
| Fax | [phone] |
| Contact Person: | Olivier Balouka – [e-mail]<br>Dario Bandiera – [e-mail] |
| Date: | October 3rd, 2016 |

## II. DEVICE

| Name of the device: | X-MIND trium |
|--------------------------|----------------------------------------------------------|
| Common or Usual<br>name: | Dental panoramic, cephalometric and CBCT X-ray<br>system |
| Classification name: | Computed tomography X-ray system (21 CFR 892.1750) |
| Regulatory class: | II |
| Product Code: | OAS, MUH |

## III. PREDICATE DEVICE

Legally marketed device to which equivalence is claimed is:

| PREDICATE DEVICE | |
|-------------------------|----------------------------------|
| Device name | Hyperion X9 |
| Manufacturer | CEFLA S.C. |
| Device product code | OAS |
| Subsequent product code | MUH |
| Regulation number | 892.1750 |
| Regulation name | Computed tomography x-ray system |
| Clearance date | 05/10/2013 |
| 510(k) number | K123381 |

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| de Götzen<br>ACTEON<br>Via Roma, 45<br>21057 Olgiate Olona (VA) | X-MIND trium<br>510 (k) Summary | 510 (k) submission<br>Section 5<br>Ed. 3.0 Of October 3rd, 2016 |
|-----------------------------------------------------------------|---------------------------------|-----------------------------------------------------------------|
|-----------------------------------------------------------------|---------------------------------|-----------------------------------------------------------------|

This predicate has not been subjected to a design-related recall.

No reference devices were used in this submission.

# IV. DEVICE DESCRIPTION

X-MIND trium is a digital panoramic, cephalometric and tomographic extra-oral Xray system, which consists of:

Image /page/4/Figure/5 description: The image shows a diagram of a dental X-ray machine and its connections to other devices. The diagram includes a computer labeled as '1', a control panel labeled as '2', a power supply labeled as '3', and the X-ray machine itself labeled as '4'. Lines connect the X-ray machine to the computer, control panel, and power supply, indicating a connection between these components.

## 1. Operator's workstation

The operator's workstation is provided optionally for the PAN only unit. The workstation allows the operator to perform the following procedures:

- Calibration of the medical device
- · Acquisition parameters setting
- Radiological image acquisition
- · Image visualization and post processing
- · Periodic quality Tests

The workstation must have installed the following modules:

- · ACTEON IMAGING SUITE (AIS) equipment management software + 2D diagnostic analysis
- · AIS 3D app (CBCT)

Communication with the medical device occurs by means of Ethernet protocol.

## 2. X-MIND trium remote control and X-MIND trium light

## X-MIND trium Remote Control

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| de Götzen<br>ACTEON | X-MIND trium | 510 (k) submission<br>Section 5 | |
|------------------------------------------|-----------------|---------------------------------|-------------------------|
| Via Roma, 45<br>21057 Olgiate Olona (VA) | 510 (k) Summary | Ed. 3.0 | Of October 3rd,<br>2016 |

The X-MIND trium remote control must be located in a safe place protected against radiations, in compliance with the local standards in force concerning ionizing radiation protection.

The X-MIND trium remote control allows the operator to activate or deactivate X-ray emission from the control room. This consists of two switches, one for exposure and one for emergency, which control device operation.

### X-MIND trium Light

Image /page/5/Picture/4 description: The image shows a white, wall-mounted device with a red, translucent cover. The device appears to be an alarm or warning system, possibly a fire alarm or emergency alert system. The red cover is curved and protrudes from the white base, suggesting it may house a light or other signaling mechanism. The device is mounted on a white surface.

The X-MIND trium Light is an indicator light that warns that X-ray emission is in progress. It indicates no entry into the room when the red light is on; it also has a triangular danger sign that warns of X-ray hazards.

## 3. X-MIND Trium medical device

Overview of the medical device: PAN/CBCT model:

Image /page/5/Figure/8 description: The image shows a dental X-ray machine with several parts labeled with numbers. The labels point to the control panel (1), the arm (2), the top of the machine (3), the upper part of the head support (4), the head support (5), the head support adjustment knob (6), the lower part of the head support (7), the chin rest (8), the body of the machine (9), and the base of the machine (10).

The X-MIND trium medical device for PAN/CBCT models consists of the following parts:

- Control panel. The control panel provides an intuitive overview of the system 1. to move the mobile column, move the bite block holder (only PAN/CBCT version), move the U-arm, turn the positioning lasers on and off and activate the X-MIND trium medical device.

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| | <div>de Götzen</div> <div>ACTEON</div> |
|--------------------------|----------------------------------------|
| | X-MIND trium |
| | 510 (k) Summary |
| Via Roma, 45 | 510 (k) submission |
| 21057 Olgiate Olona (VA) | Section 5 |
| | Ed. 3.0 |
| | Of October 3 ^rd , 2016 |

- 2. X-ray generator. The X-ray assembly is the source of the X-ray beam. An automatic collimator shapes the X-Ray beam, whereas the electronic control ensures stability and accuracy of the selected loading factors (exposure time, kVp and anodic current). A filter is used to harden the beam and remove lowenergy ionizing radiations, thereby obtaining suitable radiation quality whilst reducing the dose absorbed by the patient; the filter's material is aluminium for PAN and CEPH exams, aluminium + copper for CBCT exams.
- 3. Sliding body. The sliding body is the mobile part of the column that supports U-arm.
- 4. U-arm. The U-Arm supports the PAN/CBCT Detector sliding group and the Xray generator. This is the rotating and translating part of the medical device, which moves around the patient during the image acquisition phase; it can as well be moved in two horizontal directions (X and Y) by the operator during the setup of the exam, in order to obtain the best superimposition between the patient's head anatomy and the diameter of the Field of View (FOV).
- 5. Detector sliding group. It contains detectors that acquire PAN and CBCT images.
- 6. CBCT detector. Dedicated detector for CBCT acquisition.
- 7. PAN detector. Dedicated detector for PAN acquisition.
- Patient support. The patient support allows stabilising and immobilising the 8. patient. It can be moved vertically in order to obtain the best superimposition between the patient's head anatomy and the height of Field of View (FOV).
- 9. F group. It is the whole assembled mobile group of the device. It is the moving part of the medical device, which adapts the acquisition geometry to the patient's anatomy and stance (sitting or standing). It supports the U-Arm and head support.
- 10. Column. The fixed column supports the entire structure of the medical device. This contains the motor that raises the F Group.

Overview of the medical device: Cephalometric extension:

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| de Götzen<br>ACTEON | X-MIND trium | | 510 (k) submission<br>Section 5 |
|------------------------------------------|----------------------------------|---------|---------------------------------|
| Via Roma, 45<br>21057 Olgiate Olona (VA) | 510 (k) Summary | Ed. 3.0 | Of October 3rd,<br>2016 |
| | 11<br>12<br>13<br>14<br>15<br>16 | | |

The Cephalometric version of X-MIND trium medical device consists of the parts listed above and of the following additional parts:

11. CEPH arm extension. Can be positioned both on the right or left side of the vertical column.

12. CEPH control panel. Provides an intuitive overview of the system to move the mobile column and activate the X-MIND trium medical device.

13. CEPH patient support. Allows stabilising and immobilising the patient during CEPH exams, by means of ears rest and nasion rest.

14. CEPH detector sliding group. Enables to slide the detector to follow the X-Ray beam.

15. CEPH secondary collimator is positioned on the U-arm; it translates during X-Rays (keeping aligned the X-Ray beam emerging from the tube head with the CEPH detector);

16. CEPH detector. Gives 2D image of the whole patient head; this detector can optionally be moved from his position on CEPH arm to the PAN position on the U-arm.

The whole equipment is manufactured according to the international requlations in force relevant to ionizing radiation protection as well as mechanical and electrical safety concerning electro medical devices.

page 5 of 29

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Image /page/8/Picture/0 description: The image shows a document with the title "X-MIND trium 510 (k) Summary". It includes the text "510 (k) submission Section 5 Of October 3rd, 2016 Ed. 3.0". The document also contains the address "Via Roma, 45 21057 Olgiate Olona (VA)" and the Acteon logo.

### Control panels

Equipment control panels are used during patient positioning phase.

Proper keys allow to move equipment to the initial position before patient access, turn on the positioning lasers, adjust the U-arm position to align the patient to Xray beam and set the "ready to X-ray" status.

Some keys are duplicated on the CEPH control panel, for use during patient positioning for CEPH exams.

Image /page/8/Picture/5 description: The image shows a control panel with a variety of buttons and a small display screen. The top portion of the panel is black, while the lower portion is white. The buttons are arranged in a grid-like pattern, with directional arrows and other symbols. The brand name ACTEON is visible at the bottom of the panel.

Equipment control panel

Image /page/8/Picture/7 description: This image shows a CEPH control panel. The panel has a white background with a black border. The panel has the words "X MIND trium" in the upper right corner. There are up and down arrow buttons on the left side of the panel, and a check mark button on the right side.

CEPH control panel

#### X-MIND trium remote control

The X-MIND trium remote control must be kept in a safe place protected against radiations, in compliance with local standards in force concerning radiation protection. The X-MIND trium remote control allows the operator to activate or deactivate X-ray emissions from the control room.

The components are listed below with a brief description of the parts.

1. Safety key selector switch. Deactivates the X-ray emission switch to prevent accidental exposure.

2. X-ray emission LED. Remains on during the entire acquisition.

3. Remote emergency switch. Allows stopping the device in the event of emergency.

4. X-ray emission switch. Activates acquisition.

#### Emergency switches

This device is equipped with two emergency switches that allow to stop the movement of parts and X-ray emission in the event of an emergency.

page 6 of 29

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| de Götzen<br><b>ACTEON</b><br> | <b>X-MIND trium</b> | 510 (k) submission<br>Section 5 |
|------------------------------------------|------------------------|---------------------------------|
| Via Roma, 45<br>21057 Olgiate Olona (VA) | <b>510 (k) Summary</b> | Ed. 3.0 |
| | | Of October 3rd, 2016 |

### Patient emergency switch

Image /page/9/Picture/2 description: The image shows two pieces of medical equipment. The equipment on the left is a white, tall machine with a rectangular head and a cylindrical base. The equipment on the right is a white chair with a headrest and armrests. A red line connects the two pieces of equipment, indicating a relationship between them.

The patient emergency switch is installed on the head support and is within the patient's reach, to allow both the patient and the operator to stop the device in the event of panic or hazards, sudden column motion or any anomaly. The operator must inform and instruct the patient on the emergency procedures and on the use of the emergency switches of the device, as indicated in this chapter.

#### Remote emergency switch

Image /page/9/Picture/5 description: The image shows a top-down view of a gray, square-shaped electronic device. The device has a large, red circular button on the upper right corner. There is also a small yellow screen in the center of the device, and a dial on the upper left corner.

1= Remote emergency switch

The Remote emergency switch is located on the X-MIND trium remote control. In case of an emergency, stop any movement of the device and X-ray emission by pressing either the patient emergency switch or the remote emergency switch. This action puts the device in the emergency status.

To reset the emergency status, first solve the emergency condition and then release the emergency switch by turning it clockwise until it reaches its initial position.

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Image /page/10/Picture/0 description: This image contains the company logo for ACTEON, along with the company address, Via Roma, 45 21057 Olgiate Olona (VA). The image also contains the text X-MIND trium and 510 (k) Summary. The image also contains the text 510 (k) submission Section 5 Of October 3rd, 2016 Ed. 3.0.

#### X-ray exposure switch

Image /page/10/Picture/2 description: The image shows a gray, square-shaped device with a red button on the top right corner. There is a small, yellow screen in the center of the device. An arrow points to the yellow screen, indicating it as a key feature. The device also has a circular opening on the top left corner.

X-ray exposure switch

To activate the exposure, the operator must press and hold the X-ray exposure switch for the entire acquisition. Meanwhile, the yellow X-ray exposure LED stays on to indicate the X-ray emission.

If the operator removes his/her finger from the exposure button before the acquisition is complete, the X-ray emission and U-arm rotation will be interrupted and the X-ray exposure LED will turn off. At this point, an error message appears in the AIS software. This message must be closed before using the medical device aqain.

### Head support for PAN/CBCT exams

The head support positions and immobilizes the patient before the scan. It is equipped with a chin rest and forehead support to ensure maximum stability.

Image /page/10/Figure/8 description: This image shows a close-up of a white machine with several numbered red dots indicating different parts. The numbers range from 1 to 8, suggesting a detailed breakdown of the machine's components. The machine appears to be a medical or laboratory device, given its complex structure and various tubes and containers. The focus is on the internal mechanisms and connections within the machine.

- 1. Temple rest
- 2. Patient mirror
- 3. Local emergency switch
- 4. Courtesy tray
- 5. Handlebar
- 6. Temple knob
- 7. Chin rest
- 8. Bite block

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Image /page/11/Picture/0 description: The image is a document containing information about a 510(k) submission for X-MIND trium. It includes the company's logo, Acteon, and address, Via Roma, 45, 21057 Olgiate Olona (VA). The document is Section 5 of the 510(k) submission, edition 3.0, and is dated October 3rd, 2016.

### Head support for CEPH exams

The head support in CEPH arm positions and immobilizes the patient before the scan. It is equipped with a couple of ear rests and a nose support to ensure maximum stability.

Image /page/11/Picture/3 description: The image shows a close-up of a piece of equipment with three red lines pointing to different parts. The red line labeled '1' points to a metal arm extending downwards. The red line labeled '2' points to another metal arm, and the red line labeled '3' points to a vertical metal rod.

- 1. Ear rest
- 2. Ear rest knob
- 3. Nose support

To adapt to the patient's anatomy, the CEPH head support is equipped with:

- · Ear rest knob for horizontal ear rest movement
- Nose support that can be manually moved in horizontal and in vertical.

### Accessories

#### Temple rest

The temple rest supports provide support, frontal and lateral stability to the patient's head for all types of examination.

Image /page/11/Picture/13 description: The image shows a close-up of a white medical device with the words "TEMPLE REST" written below. Two red lines highlight the temple rest area of the device. The device appears to be used for eye exams or procedures.

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Image /page/12/Picture/0 description: This image shows a document with the title "X-MIND trium 510 (k) Summary". The document also includes the address "Via Roma, 45 21057 Olgiate Olona (VA)". The document is a 510(k) submission, section 5, edition 3.0, and is dated October 3rd, 2016.

### Chin rest

Image /page/12/Picture/2 description: The image is a close-up shot of a white object with a clear, rectangular component on top. The clear component appears to be made of plastic or glass and has a slightly curved shape. The white object has a smooth, rounded surface with some visible details, such as a thin line around the edge. The image is well-lit, and the focus is on the clear component, which reflects light and creates a sense of depth.

The chin rest allow immobilizing the patient's mouth during the 3D CBCT and the 2D maxillary sinus exams; it should also be used for 2D panoramic exams in case of edentulous patients.

### Sliding bite block and chin rest assembly

Image /page/12/Picture/5 description: The image is a close-up shot of a humidifier. The humidifier is white and has a clear water tank on top. The water tank is partially filled with water. The humidifier is sitting on a white surface.

The combined use of the bite block and the chin rest improves the stability of the iaws, allows separating the teeth during the acquisition and places in the same vertical plane the superior and the inferior incisors.

The bite block and chin rest assembly must be used for immobilizing the patient in panoramic exams except in case of edentulous patients; in addition, it can be used in CBCT scans when an improved 3D reconstruction of the dental crown surface is required.

#### TMJ nose support

This support must be used for TMJ examinations since it is specifically designed to stabilize the patient's head in both open mouth and closed mouth conditions.

#### Calibration tray and geometric calibration phantom

The Calibration tray is used to position the geometric calibration phantom during the calibration procedure of the CBCT apparatus.

The calibration procedure consists of a scan of the calibration phantom and the estimation of a set of parameters that describe the configuration of the system.

#### Quality phantom support for Germany

This accessory is intended to position the QUART DVT test phantoms for QA/QC of CBCT functionality for X-MIND trium installed in Germany.

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Image /page/13/Picture/0 description: The image is a document that appears to be a 510(k) submission summary for a product called "X-MIND trium". The document includes the address "Via Roma, 45, 21057 Olgiate Olona (VA)". The document is marked as Section 5, Edition 3.0, and dated October 3rd, 2016.

## X-MIND trium configurations

X-MIND trium can be sold in these configurations:

## PAN only

- The equipment can carry out uniquely exams of the PAN group (PAN, TMJ, . Sinus).
- . The image detector is fixed to the PAN bay.
- All the exams are carried out with the same extension in height (146 mm ● height on imaqe receptor), since the collimator has fixed dimensions.
- . The equipment can be upgraded in a later stage by replacing and adding several parts.

### PAN and CBCT

- . The equipment can carry out both exams of the PAN group (PAN, TMJ, Sinus) and of the CBCT group.
- . There are two image detectors, one for PAN and one for CBCT exam; the equipment automatically exposes in front of X-Ray source the right detector, depending on the selected exam.
- PAN exams can be carried out with different extension in height (up to 146 mm height on image receptor), since the collimator height can be adjusted depending on the exam selected by the user.
- . CBCT exams can be carried out at different FOV dimensions as specified in the technical data appendix.
- The equipment can be upgraded in the field to CEPH configuration by simple procedure, adding CEPH arm with CEPH image detector and replacing the existing PAN image detector.

## PAN / CEPH

- . The equipment can carry out both exams of the PAN group (PAN, TMJ, Sinus) and of the CEPH group (AP/PA, LL, carpus).
- The image detector can optionally be unique, for both PAN and CEPH exams; . in this case it must be manually moved by the operator from PAN bay to CEPH bay and vice versa, depending on the selected exam. Otherwise, two different dedicated detectors can be provided: one for CEPH exams and the other one for PAN exams.
- The exams can be carried out with different extension in height (up to 146 mm height on image receptor for PAN, up to 220 mm height on image receptor for CEPH), since the primary collimator can be automatically adjusted in height depending on exam selected by the user.

{14}------------------------------------------------

| de Götzen<br>ACTEON | X-MIND trium | 510 (k) submission<br>Section 5 | |
|------------------------------------------|-----------------|---------------------------------|----------------------|
| Via Roma, 45<br>21057 Olgiate Olona (VA) | 510 (k) Summary | Ed. 3.0 | Of October 3rd, 2016 |

- The equipment can be upgraded in-field to CBCT configuration by a simple . procedure, adding the CBCT image detector and the bite block holder with vertical movement.
## PAN / CBCT / CEPH

- . The equipment can carry out all feasible exams of the PAN group (PAN, TMJ, Sinus), CEPH group (AP/PA, LL, carpus) and CBCT group.
- . There are optionally two image detectors, one for PAN/CEPH and one for CBCT exams; in this case the PAN/CEPH image detector must be manually moved by the operator from PAN bay to CEPH bay and vice versa; otherwise three image detectors, one for PAN, one for CEPH and one for CBCT exams.
- . To carry out PAN or CEPH or CBCT exams the equipment automatically exposes in front of X-Ray source the right detector, depending on the selected exam.
- PAN and CEPH exams can be carried out with different extension in height (up to 146 mm height on image receptor for PAN, up to 220 mm height on image receptor for CEPH), since the primary collimator can be automatically adjusted in height depending on exam selected by the user;
- . CBCT exams can be carried out at different FOV dimensions as specified in the technical data appendix.

## Exams

In its different configurations, X-MIND trium equipment carries out the following exams:

## Panoramic group

The panoramic group includes all the 2D radiographs of the jaws, dentition, temporomandibular joints and maxillary sinuses.

- 1) Standard panoramic
- Full scan
- · Right side only
- Left side only
- 2) Sectorial panoramic with improved orthogonality
- . Full scan
- Right side only .
- Left side only .
- 3) Frontal panoramic
- 4) Bitewings

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Image /page/15/Picture/0 description: This image is a document that contains the company logo and address on the left side. The company logo is "ACTEON" in blue and green. The address is "Via Roma, 45 21057 Olgiate Olona (VA)". The document also contains the title "X-MIND trium 510 (k) Summary" in bold. On the right side, it contains the text "510 (k) submission Section 5 Ed. 3.0 Of October 3rd, 2016".

- 5) Frontal temporomandibular joint with closed or open mouth
- Both sides .
- Left TMJ only .
- Right TMJ only .
- 6) Lateral temporomandibular joint with closed or open mouth
- Both sides ●
- . Left TMJ only
- Right TMJ only
- 7) Frontal maxillary sinuses
- 8) Lateral maxillary sinuses
- Left sinus only .
- . Right sinus only

## CBCT group

The CBCT group includes all the 3D CBCT examinations of the dental and maxillofacial regions.

Here below the size of the reconstructed volumes expressed as diameter x height.

- 1) Dental FOV
- 40mm x 40mm
- 60mm x 60mm
- 80mm x 80mm
- 110mm x 80mm
- 2) ENT FOV Nose
- 110mm x 80mm
- 3) ENT FOV Ear
- Left ear only, 60mm x 60mm
- . Right ear only, 60mm x 60mm

#### Cephalometric group

- 1) Frontal (AP/PA)
- 2) Lateral (LL)
- 3) Hand acquisition (Carpus special support needed)

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| de G ötzen |
|-----------------|
| ACTEON |

510 (k) submission Section 5

Via Roma, 45 21057 Olgiate Olona (VA)

510 (k) Summary

# V. INDICATIONS FOR USE

X-MIND trium is a digital panoramic, cephalometric and tomographic extra-oral Xray system, indicated for use in:

- producing panoramic X-ray images for diagnostic examination of dentition (teeth), jaws and oral structures;

producing radiographs of maxillofacial region and parts of the skull for ı cephalometric examination, if equipped with CEPH arm;

- producing radiographs of hands and wrists for carpus examination, if equipped with CEPH arm;

- producing tomographic images of the oral and maxillofacial region, for diagnostic examination of dentition (teeth), jaws, oral structures and some cranial bones, if equipped with CBCT option.

From a clinical point of view, X-MIND trium can be applied for the following medical indications :

- · Generic dentistry
- Dental implantology
- Dental surgery
- Maxillo-facial surgery
- Cephalometric analysis
- · Carpus radiology

The target patient population includes adults and pediatric patients from 5 years old [~21 kg (46 lb); 113 cm (44.5 in) standing height]; anyway the sustainability to Xray exposure must be evaluated by surqeons, dentists and qualified and authorized physicians.

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Image /page/17/Picture/0 description: The image contains the logo for Acteon. The logo is blue and has a green swoosh on the left side. Above the word Acteon is the text "de Gotzen" in a smaller font.

510 (k) submission Section 5

Via Roma, 45 21057 Olgiate Olona (VA)

510 (k) Summary

Of October 3rd, Ed. 3.0 2016

## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

| | Proposed | Predicate |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | X-MIND trium | HYPERION X9 |
| Manufacturer | de Götzen S.r.l. - Acteon<br>Group<br>Via Roma, 45<br>21057 Olgiate Olona<br>VA - Italia | Cefla s.c.<br>Via Selice Prov.le, 23/a<br>40026 Imola<br>BO - Italia |
| 510 (k) number | K160166 | K123381 |
| Indication for<br>use | X-MIND trium is a digital<br>panoramic, cephalometric and<br>tomographic extra-oral X-ray<br>system, indicated for use in:<br>- producing panoramic X-ray<br>images for diagnostic<br>examination of dentition<br>(teeth), jaws and oral<br>structures;<br>- producing radiographs of<br>maxillofacial region and parts<br>of the skull for cephalometric<br>examination, if equipped with<br>CEPH arm;<br>- producing radiographs of<br>hands and wrists for carpus<br>examination, if equipped with<br>CEPH arm;<br>- producing tomographic<br>images of the oral and<br>maxillofacial region, for<br>diagnostic examination of<br>dentition (teeth), jaws, oral<br>structures and some cranial<br>bones, if equipped with CBCT<br>option. | Hyperion X9 is a digital<br>panoramic, cephalometric<br>and tomographic extra-oral<br>X-ray system, indicated for<br>use in:<br>Producing panoramic X-ray<br>images of the maxillo-<br>facial area, for diagnostic<br>examination of dentition<br>(teeth), jaws and oral<br>structures;<br>Producing radiographs of<br>jaws, parts of the skull and<br>carpus for the purpose of<br>cephalometric examination<br>with tele-radiographic arm<br>(CEPH);<br>Producing tomographic<br>images of the oral and<br>maxillofacial structure, for<br>diagnostic examination of<br>dentition (teeth), jaws,<br>oral structures and some<br>cranial bones if equipped<br>with CBCT option. |
| | Proposed | Predicate |
| Characteristic | X-MIND trium | HYPERION X9 |
| | From a clinical point of view,<br>X-MIND trium can be applied<br>for the following medical<br>indications: | From a clinical point of view,<br>X-MIND trium can be applied<br>for the following medical<br>indications: |
| | Generic dentistry | Generic dentistry<br>Conservative dentistry:<br>• Endodontics;<br>• Periodontology;<br>• Dental prostheses;<br>Orthodontics. |
| | Dental implantology | Dental implantology<br>Implantation |
| | Dental surgery | Dental surgery<br>Surgical dentistry |
| | Maxillo-facial surgery | Maxillo-facial surgery<br>Maxillofacial surgery |
| | Cephalometric analysis | Cephalometric analysis<br>Functional diagnostics and<br>treatment of craniomandibular<br>dysfunctions |
| | Carpus radiology | Carpus radiology |
| | The target patient population<br>includes adults and pediatric<br>patients from 5 years old<br>[~21 kg (46 lb); 113 cm<br>(44.5 in) standing height];<br>anyway the sustainability to<br>X-ray exposure must be<br>evaluated by surgeons,<br>dentists and qualified and<br>authorized physicians. | The target patient population<br>includes adults and pediatric<br>patients from 5 years old<br>[~21 kg (46 lb); 113 cm<br>(44.5 in) standing height];<br>anyway the sustainability to<br>X-ray exposure must be<br>evaluated by surgeons,<br>dentists and qualified and<br>authorized physicians. |
| Performance | 1) Panoramic<br>2) Cephalometric (optional) | 1) Panoramic<br>2) Cephalometric (optional) |
| specifications | 3) CBCT (optional) | 3) CBCT (optional) |
| Exam mode | 1) PAN:<br>- standard panoramic<br>- child panoramic<br>- TMJ | 1) PAN<br>- standard panoramic<br>- child panoramic<br>- TMJ |
| Characteristic | Proposed<br>X-MIND trium | Predicate<br>HYPERION X9 |
| | - bitewing<br>- sectorial panoramic with<br>improved orthogonality<br>- maxillary sinuses<br>2) CEPH:<br>- frontal (AP/PA)<br>- lateral (LL)<br>- hand acquisition - carpus<br>(special support needed)<br>3) CBCT:<br>- full view<br>- extended view | - bitewing<br>- sectorial panoramic<br>- maxillary sinuses<br>2) CEPH:<br>- frontal (AP/PA)<br>- lateral (LL)<br>- carpus (with special hand<br>support)<br>3) CBCT:<br>- full view<br>- extended view |
| Device power supply | | |
| Type of power supply | Single-phase alternating<br>current power supply | Single-phase alternating<br>current power supply |
| Nominal voltage | 100 V - 240V | 115 V - 240 V |
| Maximum voltage variation | $\pm$ 10% | $\pm$ 10% |
| Nominal current | 7 A (@ 240 V)<br>15 A (@ 100 V) | 7 A (@ 240 V)<br>14 A (@ 115V) |
| Frequency | 50 - 60 Hz | 50 - 60 Hz |
| Operation mode | Continuous operation with<br>intermittent X-ray loading | Continuous operation with<br>intermittent X-ray loading |
| Electrical classification (IEC 60601-1) | | |
| Protection against<br>electrical shock | Class I | Class I |
| Degree of protection<br>against<br>electrical shock | Type B | Type B…