X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)

K203374 · De Götzen S.R.L. · MUH · Feb 5, 2021 · Dental

Device Facts

• Record ID: K203374
• Device Name: X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)
• Applicant: De Götzen S.R.L.
• Product Code: MUH · Dental
• Decision Date: Feb 5, 2021
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: Pediatric

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]. Anyway, the sustainability to X-ray exposure must be evaluated by surgeons, dentists and qualified and authorized physicians.

Device Story

X-MIND prime is an extraoral dental X-ray system for 2D imaging of maxillofacial structures. Input: X-ray radiation passing through patient anatomy. Transformation: High-frequency X-ray generator produces beam; CMOS flat panel detector (Teledyne DALSA Xineos-2301) captures signals; system performs panoramic or cephalometric scanning. Output: 2D digital radiographic images. Used in dental clinics by dentists/radiologists. Device features motorized height adjustment, laser positioning, and patient support tools (temple clamps, bite block, chin support, ear/nasion rests). For cephalometric exams, detector moves to cephalometric arm; secondary collimator limits beam to region of interest. Digital filters enhance soft tissue visibility. Output viewed on PC via proprietary software; assists clinicians in diagnosis and treatment planning. Benefits: diagnostic imaging of teeth/jaw/skull with optimized radiation dose.

Clinical Evidence

Bench testing only. Performance data included electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and radiation safety (21 CFR 1020.30/31). Image quality equivalence for cephalometric and pediatric panoramic exams was established via bench testing and independent review by a dental professional.

Technological Characteristics

Extraoral X-ray system; high-frequency generator; CMOS flat panel detector (CsI scintillator, 99μm pixel size, 14-bit depth). Connectivity: Giga-Ethernet to PC. Power: 110-240V. Mounting: Wall/Floor. Software: Multi-CPU architecture (CAN bus). Sterilization: N/A (non-contact).

Indications for Use

Indicated for 2D radiographic exams of teeth, jaw, and oral structures (panoramic, TMJ, sinus) and, for models with cephalometric arm, cranial cephalometric exams and wrist (Carpus) exams for bone growth evaluation. Target population: adults and pediatric patients from 7 years old (~27 kg, 125 cm standing height).

Regulatory Classification

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.

Predicate Devices

• Rotograph Evo D (K090749)

Reference Devices

• DENTIOIII Series (DENTIOIII, DENTIOIII-S) (K181297)
• Rotograph Prime (K162190)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the agency's name on the right. The symbol on the left is a stylized depiction of the Department of Health and Human Services emblem. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue font.

February 5, 2021

de Götzen S.r.l. % Dario Bandiera Quality Assurance and Regulatory Affairs Manager Via Roma, 45 Olgiate Olona. Varese 21057 ITALY

#### Re: K203374

Trade/Device Name: X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: November 9, 2020 Received: November 16, 2020

#### Dear Dario Bandiera:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K203374

#### Device Name

X-MIND prime (under trade mark Acteon) I-MAX (under trade mark Owandy Radiology)

#### Indications for Use (Describe)

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].

Anyway, the sustainability to X-ray exposure must be evaluated by surgeons, dentists and qualified and authorized physicians.

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

| <span style="font-family: Arial;"> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|----------------------------------------------------------------------------------------------|
| <span style="font-family: Arial;"> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Acteon, a company whose name is written in bold, sans-serif font. A blue swoosh underlines the company name. Below the logo, the text "Via Roma, 45" is visible, likely indicating the company's address.

21057 Olgiate Olona (VA)

# X-MIND prime

VOL. 004

510(k) Summary

## Index

| I. | SUBMITTER | 2 |
|-------|------------------------------------------------------------------------|----|
| II. | PROPOSED DEVICE | 2 |
| III. | PREDICATE DEVICE and REFERENCE DEVICES | 2 |
| IV. | DEVICE DESCRIPTION | 3 |
| V. | INDICATIONS FOR USE | 9 |
| VI. | COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES | 10 |
| VII. | PERFORMANCE DATA AND TESTING EVIDENCE. | 21 |
| VIII. | FDA GUIDANCE DOCUMENTS | 23 |
| IX. | CONCLUSION | 23 |

| Rev. n. 2 | VOL. 004 |
|------------|-------------------------------------------------|
| 01/02/2021 | X-MIND prime 510(k) Abbreviated<br>Page 1 of 24 |

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Acteon, which is a blue swoosh over the company name in black, followed by the text "Via Roma, 45" in black. The logo is simple and modern. The text is located below the logo. The text is left-aligned.

VOL. 004

001_Summary

21057 Olgiate Olona (VA)

## 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: | Dario Bandiera – [e-mail] |
| Date: | November 9th, 2020 |

Table 1: Submitter information

#### PROPOSED DEVICE II.

| Name of the device: | X-MIND prime (under trademark Acteon)<br>I-MAX (under trademark Owandy Radiology) |
|-----------------------|-----------------------------------------------------------------------------------|
| Common or Usual name: | Dental panoramic and cephalometric system |
| Classification name: | Extraoral source X-ray system (21 CFR 872.1800) |
| Regulatory class: | II |
| Product Code: | MUH |

Table 2: Proposed device information

#### PREDICATE DEVICE and REFERENCE DEVICES III.

Legally marketed devices to which equivalence is claimed is:

| PREDICATE DEVICE | |
|---------------------|-------------------------------|
| Device name | Rotograph Evo D |
| Manufacturer | Villa Sistemi Medicali |
| Device product code | MUH |
| Regulation number | 872.1800 |
| Regulation name | Extraoral source x-ray system |
| Clearance date | May 18th, 2009 |
| 510(k) number | K090749 |

Table 3: Predicate device information

| Rev. n. 2 | X-MIND prime 510(k) Abbreviated | VOL. 004 |
|------------|---------------------------------|--------------|
| 01/02/2021 | | Page 2 of 24 |

{5}------------------------------------------------

| <br>Via Roma, 45<br>21057 Olgiate Olona (VA) | X-MIND prime<br>510(k) Summary | VOL. 004<br>001_Summary |
|----------------------------------------------|--------------------------------|-------------------------|
|----------------------------------------------|--------------------------------|-------------------------|

| REFERENCE DEVICE #1 | |
|---------------------|-------------------------------------------|
| Device name | DENTIOIII Series (DENTIOIII, DENTIOIII-S) |
| Manufacturer | HDX WILL CORP. |
| Device product code | MUH |
| Regulation number | 872.1800 |
| Regulation name | Extraoral source x-ray system |
| Clearance date | November 21st, 2018 |
| 510(k) number | K181297 |

Table 4: Reference device #1 information

| REFERENCE DEVICE #2 | |
|---------------------|-----------------------------------------------------|
| Device name | Rotograph Prime (New proprietary name X-MIND prime) |
| Manufacturer | de Götzen S.r.l. – ACTEON Group |
| Device product code | MUH |
| Regulation number | 872.1800 |
| Regulation name | Extraoral source x-ray system |
| Clearance date | July 6th, 2017 |
| 510(k) number | K162190 |

Table 5: Reference device #2 information

#### IV. DEVICE DESCRIPTION

NOTE: In the following, all the reference to X-MIND prime are applicable also to I-MAX under trademark Owandy Radiology

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)

| Rev. n. 2<br>01/02/2021 | X-MIND prime 510(k) Abbreviated | VOL. 004<br>Page 3 of 24 |
|-------------------------|---------------------------------|--------------------------|
|-------------------------|---------------------------------|--------------------------|

{6}------------------------------------------------

| ACTEON |
|--------------------------|
| Via Roma, 45 |
| 21057 Olgiate Olona (VA) |

| X-MIND prime |
|----------------|
| 510(k) Summary |

| VOL. 004 |
|-------------|
| 001_Summary |

- 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.

### OVERVIEW OF THE DEVICE

The reason of the present submission is the introduction of a significative change on X-MIND prime device (listing number D342124 and FDA clearance K162190).

This significant change mostly consists in the addition of the cephalometric arm to X-MIND prime, as shown in overview figure below:

Image /page/6/Figure/7 description: The image shows two dental X-ray machines, labeled as 'X-MIND prime without CEPH arm' and 'X-MIND prime with CEPH arm'. Both machines have several parts marked with numbers from 1 to 8, while the 'X-MIND prime with CEPH arm' also has parts marked with numbers 9 to 12. The image serves to illustrate the different components of the X-ray machines and highlight the distinction between the models with and without the CEPH arm.

Figure 1: overview of the scanner in the configurations without and with the cephalometric arm

| Rev. n. 2 | X-MIND prime 510(k) Abbreviated | VOL. 004 |
|------------|---------------------------------|--------------|
| 01/02/2021 | | Page 4 of 24 |

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for Acteon. The logo is black text with a blue swoosh underneath. The text is bold and sans-serif.

VOL. 004

(k) Summary

Via Roma, 45 21057 Olgiate Olona (VA) 510(k) Summary

001_Summary

summary

X-MIND prime device consists of the following parts:

| 1 | Control panel | The control panel provides an intuitive overview of the system and<br>hold the keys to move up and down the column, turn on and off<br>the positioning lasers and reset the device to the start exam<br>position.<br>Image: Control Panel |
|---|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2 | Detector group | It contains the PAN/CEPH detector for the acquisition of the<br>radiographic images of the maxillo-facial region. When placed on<br>the rotating arm, the detector is ready for the acquisition of<br>panoramic images. Further, the detector can be moved from the<br>rotating arm to the cephalometric arm in order to perform the<br>cephalometric examinations. |
| 3 | Fixed arm | It supports the rotating arm. |
| 4 | Telescopic Column | The telescopic column supports and moves the entire structure of<br>the medical device.<br>In the version without CEPH arm it is fixed to the wall without any<br>footrest;<br>in the version with CEPH arm it is fixed to the wall and resting on<br>the floor. |
| 5 | Patient handgrip | Handgrips held by the patient during the exam. |
| 6 | Patient support | The patient support allows to stabilise and immobilise the patient.<br>It is equipped with tools to position the patient head to fit the<br>patient's anatomy to the Field of View (FOV). |
| 7 | X-ray generator | The X-ray assembly is the source of the X-ray beam during the<br>exams. The beam is modelled by a collimator; the electronic<br>control ensures precision and accuracy of selected loading factors<br>(kVp and anodic current). The tubehead aluminium additional<br>filtration fits the CFR 21 part 1020.30 and remove low-energy<br>ionising radiations, obtaining suitable radiation quality while<br>reducing the dose absorbed by the patient. |

| Rev. n. 2 | X-MIND prime 510(k) Abbreviated | VOL. 004 |
|------------|---------------------------------|----------|
| 01/02/2021 | Page 5 of 24 | |

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for Acteon. The logo is in black, with a blue swoosh underneath the first few letters. The text is bold and sans-serif.

VOL. 004

001_Summary

Via Roma, 45 21057 Olgiate Olona (VA)

# 510(k) Summary

| 8 | Rotating arm | The rotating arm supports the detector and the X-ray generator.<br>This is the rotating part of the medical device, which moves around<br>the patient during the image acquisition phase of panoramic<br>exams. |
|----|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 9 | CEPH arm | In the version of X-MIND prime with cephalometric arm, it allows<br>the execution of cephalometric exams: radiographic images of<br>the patient skull in LL and AP views and of the patient's wrist to<br>evaluate the bone growth (using the carpus plate provided with<br>the cephalometric function). |
| 10 | CEPH craniostat | The craniostat is the patient positioning aiming device (composed<br>by ear and nasion rest) for the cephalometric exams. |
| 11 | CEPH 2ry collimator | The CEPH 2ry collimator is translating during X-Rays in sync with<br>CEPH detector and 1ry collimator (to collimate on CEPH detector<br>the X-Ray beam emerging from the generator). |
| 12 | Detector | When mounted on the cephalometric arm, detector is translating<br>during X-Rays in sync with CEPH 2ry collimator and 1ry collimator<br>(to generate radiographic images of the patient skull in LL and AP<br>views and of the patient's wrist). |

Table 6: X-MIND prime parts

| Rev. n. 2<br>01/02/2021 | X-MIND prime 510(k) Abbreviated | VOL. 004<br>Page 6 of 24 |
|-------------------------|---------------------------------|--------------------------|
|-------------------------|---------------------------------|--------------------------|

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo for Acteon. The logo is in black and has a blue swoosh underneath the left side of the word. The word "ACTEON" is in all caps and in a bold sans-serif font.

### EQUIPMENT CONFIGURATIONS

X-MIND prime can be sold in these different configurations:

#### PAN

In this configuration, X-MIND prime is equipped only with the PAN detector which allows to acquire the panoramic exams.

#### PAN / CEPH

The equipment can carry out the panoramic and cephalometric exams.

The device is equipped with a PAN/CEPH detector which allows to acquire both panoramic and cephalometric exams. The PAN/CEPH detector can be moved from the rotating arm to the cephalometric arm and viceversa, according to the type of exam to be performed.

#### LIST OF EXAMS

X-MIND prime is a complete panoramic X-ray system that can perform the following exams:

### 2D examination programs

- . Standard Panoramic exam
- TM| closed and open mouth: 4 slices are taken in the same image (left/right condyle, open/close . mouth). Condyles are examined in lateral projection
- TMJ single phase .
- . Sinus P/A projection: one P/A projection, where both the maxillary sinuses are represented.
- Half Panoramic (left/right): panoramic acquired only on the right or left side of the mouth .

. Ortho Rad Panoramic: panoramic projection limited to the dentition, obtained with X-ray beam constantly perpendicular to the arch. It allows to reduce superimposition of adjacent teeth and to improve visualization of possible interproximal caries

. Frontal Dentition: panoramic limited to the frontal dentition (canine to canine), that allows to improve the detail definition on incisors

. Low Dose Panoramic: panoramic with reduced angle of rotation to exclude the ascending ramus from the image. The result is a panoramic limited to the dentition area using a reduced patient dose

. Bitewing (Left/Right/Left and Right): the left or right projection allows the examination of lateral dentition (from eighth to fourth approximately), with optimized trajectory of rotating arm for a higher orthogonality of the x-ray beam on the adjacent teeth, to improve visualization of possible interproximal caries. Left and Right Bitewing projection performs both Bitewing views in sequence, joining them on the same image

| Rev. n. 2 | X-MIND prime 510(k) Abbreviated | VOL. 004 |
|------------|---------------------------------|--------------|
| 01/02/2021 | | Page 7 of 24 |

{10}------------------------------------------------

21057 Olgiate Olona (VA)

Via Roma, 45

## X-MIND prime

## Cephalometric examination programs

- Cephalometric L-L projections (with formats 18x24, 24x24, 30x24 and 18x18, 24x18, 30x18): exam . of the skull acquired in lateral projection. The selection between HS High Speed and HD High Definition is available.
- Cephalometric A-P projections (with formats 24x24 and 24x18): exam of the skull acquired in . frontal position. The selection between HS High Speed and HD High Definition is available.
- . Carpus Projection (with format 18x24): exam specifically intended for evaluating the state of calcification and the patient's bone growth trend. The exam is available only in HD High Definition mode.

For each exam it is possible to select patient type (Adult or Child) and the patient size (small, medium, large) to allow the automatic selection of the pre-set exposure parameters. Otherwise, the user has the possibility to select the exposure parameters manually, with a high voltage ranging between 60 and 86 kV in 2 kV steps, and with the anodic current ranging from 2 mA to 12.5 mA with R20 scale steps.

### PRINCIPLES OF OPERATION

The X-ray generator and the detector (PAN/CEPH) are the most important parts of the X-MIND prime device and allow the acquisition of the radiographic images of the maxillofacial complex. The PAN/CEPH detector and the X-ray source are mounted on the rotating arm of the device. The detector can be moved from the rotating arm to the cephalometric arm when the cephalometric examinations must be acquired.

During the panoramic exams, the rotating arm rotates up to 200° (depending on the selected exams) around the patient's head, and the detector acquires a set of radiographic images. A collimator ensures an efficient use of the radiation, minimising the exposed area only on the anatomical region of interest.

The raw images are processed to obtain a 2D panoramic image.

In order to acquire the cephalometric exams, the detector performs a horizontal linear scanning of the skull, while the focus is kept in a fixed position and guaranteeing the same projection geometry as if using a film. The X-ray source is automatically aligned to digital sensor. The use of a secondary collimator on the cephalometric arm ensures the minimum level of radiation to the patient limiting the size of the fan shaped beam to the target region of interest. A digital filter is automatically applied to lateral cephalometric images to enhance the visibility of soft tissues profile while preserving the bone structures.

| Rev. n. 2 | X-MIND prime 510(k) Abbreviated | VOL. 004 |
|------------|---------------------------------|--------------|
| 01/02/2021 | | Page 8 of 24 |

{11}------------------------------------------------


| | Via Roma, 45 |
|--|--------------|
|--|--------------|

21057 Olgiate Olona (VA)

## X-MIND prime

#### INDICATIONS FOR USE V.

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, TMJ 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].

Anyway, the sustainability to X-ray exposure must be evaluated by surgeons, dentists and qualified and authorized physicians.

| Rev. n. 2 | X-MIND prime 510(k) Abbreviated | VOL. 004 |
|------------|---------------------------------|--------------|
| 01/02/2021 | | Page 9 of 24 |

{12}------------------------------------------------

Image /page/12/Picture/0 description: The image shows the logo for ACTEON. The logo is in black and has a stylized wave-like design in blue on the left side. The text "ACTEON" is in bold, sans-serif font.

VOL. 004

001_Summary

#### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE and REFERENCE DEVICES

NOTE: In the following, all the reference to X-MIND prime are applicable also to I-MAX under trademark Owandy Radiology

| | Proposed device:<br>X-MIND prime | Predicate device:<br>Rotograph Evo D | Reference<br>device #1:<br>DENTIOIII series<br>(DENTIOIII,<br>DENTIOIII-S) | Reference<br>device#2:<br>Rotograph Prime |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | X-MIND prime is an<br>extra-oral dental<br>panoramic X-ray<br>unit to take two<br>dimensional<br>radiographic exams<br>of teeth, jaw and<br>oral structures<br>(panoramic, TMJ<br>and sinus exams).<br>The models with<br>cephalometric arm<br>will be able to take<br>two dimensional<br>cranial<br>cephalometric<br>exams in different<br>projections and the<br>wrist exam (Carpus)<br>dedicated to the<br>evaluation of the<br>bone growth. | Rotograph Evo D,<br>panoramic x-ray<br>imaging systems<br>with cephalostat,<br>are extraoral source<br>x-ray systems,<br>which are intended<br>for dental<br>radiographic<br>examination of the<br>teeth, jaw, and oral<br>structures,<br>specifically for<br>panoramic<br>examinations and<br>implantology and<br>for TMJ studies and<br>cephalometry. | | Rotograph Prime is<br>an extra-oral dental<br>panoramic<br>X-ray unit to<br>radiograph teeth,<br>jaw and oral<br>structures. |

| Rev. n. 2 | X-MIND prime 510(k) Abbreviated | VOL. 004 |
|------------|---------------------------------|---------------|
| 01/02/2021 | | Page 10 of 24 |

{13}------------------------------------------------

Image /page/13/Picture/0 description: The image shows the logo for ACTEON. The logo is in black and has a blue swoosh on the left side. The text is in all caps and is bolded.

VOL. 004

Via Roma, 45 21057 Olgiate Olona (VA) 510(k) Summary

001_Summary

---

| Proposed device:<br>X-MIND prime | Predicate device:<br>Rotograph Evo D | Reference<br>device #1:<br>DENTIOIII series<br>(DENTIOIII,<br>DENTIOIII-S) | Reference<br>device#2:<br>Rotograph Prime |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The device is<br>operated and used<br>by dentists,<br>radiologists and<br>other legally<br>qualified health care<br>professionals, i.e.<br>Prescription Use<br>(Part 21 CFR 801<br>Subpart D).<br>The target patient<br>population includes<br>adults and pediatric<br>patients from 7<br>years old [~27 kg<br>(59.5 lb); 125 cm<br>(49.2 in) standing<br>height].<br>Anyway, the<br>sustainability to X-<br>ray exposure must<br>be evaluated by<br>surgeons, dentists<br>and qualified and<br>authorized<br>physicians | | The DENTIOIII<br>series is intended<br>for dental<br>radiographic<br>examination of the<br>teeth and<br>temporomandibular<br>joints, specifically<br>for panoramic and<br>cephalometric<br>examinations. It is<br>to be used only by<br>dental practitioners<br>and/or radiologists | The device is<br>operated and used<br>by dentists,<br>radiologists and<br>other legally<br>qualified health care<br>professionals.<br>It can be used with<br>both pediatric and<br>adult patients. |

Table 7: Comparison of the intended use among proposed and predicate devices.

| Rev. n. 2 | | VOL. 004 |
|------------|---------------------------------|---------------|
| 01/02/2021 | X-MIND prime 510(k) Abbreviated | Page 11 of 24 |

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

Via Roma, 45

## X-MIND prime

### Detailed comparison of similarities and differences

The intended use of the proposed device and of the predicate device are the same:

They have the same functions in the same environment. in particular, the proposed device performs the same exams for the examination of teeth, jaw, oral structures, cranial cephalometric exams in different projections and the wrist exam

The intended use of the proposed device is taken from labelling (operator's manual) for this reason it is intended to be explicative and as detailed as possible to be clear for the intended user, the intended use of Rotograph Evo D, is taken from "Indications for use" available in K090749 Summary and it is more synthetic in the form but it covers all the proposed device intended use

The following table highlights the existing similarities between the proposed device and the predicate device.

| | Proposed device:<br>X-MIND prime | Predicate device:<br>Rotograph Evo D |
|--------------------------------------------------------------------------|----------------------------------|--------------------------------------|
| 2D Examination programs | | |
| Panoramic exam | Yes | Yes |
| Ortho Rad Panoramic | Yes | Yes |
| Segmented Panoramic (Half<br>panoramic, frontal dentition,<br>bitewings) | Yes | Yes |
| Low dose panoramic | Yes | Yes |
| TMJ Closed/Open mouth | Yes | Yes |
| TMJ single phase | Yes | Yes |
| Sinus | Yes | Yes |
| 2D Exam characteristics | | |
| Magnification (Panoramic) | 1.23 constant | 1.23 constant |

| Rev. n. 2 | | VOL. 004 |
|------------|---------------------------------|---------------|
| 01/02/2021 | X-MIND prime 510(k) Abbreviated | Page 12 of 24 |

{15}------------------------------------------------

ACTEON

# X-MIND prime

VOL. 004

001_Summary

## Via Roma, 45 21057 Olgiate Olona (VA)

| 510(k) Summary |
|----------------|
|----------------|

| | Proposed device:<br>X-MIND prime | Predicate device:<br>Rotograph Evo D |
|-----------------------------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------|
| Source to image distance | 500 mm | 500 mm |
| Magnification (cephalometric) | 1.1 constant | 1.1 constant |
| Source to image distance<br>(cephalometric) | 1650 mm | 1650 mm |
| Panoramic max image size | equivalent to 15x30 cm film | equivalent to 15x30 cm film |
| Adult panoramic scan time | 14 sec | 13.8 sec |
| Child panoramic exam with<br>shorter scan time than adult<br>panoramic exam | 12.8 sec | 13.8 sec |
| Cephalometric image sizes | From 18 x 18 to 24 x 30<br>(height x width) | From 24 x 18 to 24 x 30<br>(height x width) |
| Cephalometric scan time | From 4.4 s to 15.1 s depending<br>on image size | From 4.5 s to 15 s depending on<br>image size |
| Generator/tube<br>characteristics | | |
| X-ray generator | High frequency | High frequency |
| Focal spot value | 0.5 mm (IEC 60336) | 0.5 mm (IEC 60336) |
| Anode type | Fixed | Fixed |
| X-ray exposure time control | Automatic - pre-programmed<br>Microprocessor Controlled | Automatic – pre-programmed<br>Microprocessor Controlled |
| Independent kV-mA regulation | Yes | Yes |
| DAP Software | Yes | Yes |

| Rev. n. 2 | | VOL. 004 |
|------------|---------------------------------|---------------|
| 01/02/2021 | X-MIND prime 510(k) Abbreviated | Page 13 of 24 |

{16}------------------------------------------------

ACTIEOI

# X-MIND prime

VOL. 004

Via Roma, 45 21057 Olgiate Olona (VA) 510(k) Summary

001_Summary

| | Proposed device:<br>X-MIND prime | Predicate device:<br>Rotograph Evo D |
|-----------------------------------------------------|----------------------------------------------------|---------------------------------------------------------------------|
| kV Range | 60 - 86 kV step 2kV | 60 - 86 kV step 2kV |
| Total filtration | 2.5 mm Al eq | 2.5 mm Al eq |
| Collimator | Automatic | Automatic |
| mA range | 2 - 12.5 mA | 6 - 12 mA |
| Patient positioning | | |
| Height adjustment | Motorized | Motorized |
| Positioning lights | 2 laser pointers | 2 laser pointers |
| Patient position | Standing | Standing |
| Patient positioning tools | Temple clamps, bite block, chin support | Temple clamps, bite block, chin support |
| Focal layer adjustment<br>(prognatism compensation) | Electronic, three positions, no patient movement | Electronic, three positions, no patient movement |
| Patient positioning orientation vs the operator | Face to face | Face to face |
| Patient positioning tools in cephalometric exams | Ear rods, nasion support | Ear rods, nasion support |
| User interface | | |
| PC connection | Dedicated Giga-Ethernet channel | Ethernet connection |
| User interface | Onboard keyboard and virtual control panel (on PC) | Onboard keyboard with touchscreen and virtual control panel (on PC) |

| Rev. n. 2<br>01/02/2021 | X-MIND prime 510(k) Abbreviated | VOL. 004<br>Page 14 of 24 |
|-------------------------|---------------------------------|---------------------------|
|-------------------------|---------------------------------|---------------------------|

{17}------------------------------------------------

ACTHEC

# X-MIND prime

VOL. 004

001_Summary

Via Roma, 45 21057 Olgiate Olona (VA) 510(k) Summary

| | Proposed device:<br>X-MIND prime | Predicate device:<br>Rotograph Evo D |
|---------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Software | | |
| System architecture | Based on multiple CPUs<br>connected via Can Bus plus<br>Ethernet connection to PC | Based on multiple CPUs<br>connected via Can Bus plus<br>Ethernet connection to PC.<br>In this case, the device has two<br>more CPUs for controlling the<br>onboard GUI and vertical<br>column |
| Firmware functions<br>(of MCU and CCU Control<br>Processing Units) for<br>controlling movements and<br>image<br>acquisition/synchronization | Firmware functions are<br>designed to manage the<br>panoramic version and the<br>cephalometric option. Some<br>differences are related to<br>specific hardware solutions or<br>different microprocessors<br>from the Predicate Device. | Firmware functions are<br>designed to manage the<br>following configurations: Film<br>Version, digital panoramic<br>version, cephalometric option |
| X-ray generator board firmware<br>functions | X-ray parameters (kV, mA)<br>management, X-ray start and<br>stop, errors control.<br>Can Bus communication. | X-ray parameters (kV, mA)<br>management, X-ray start and<br>stop, errors control.<br>Can Bus communication. |
| Communication protocol<br>between the computer and<br>Controlling Processing Unit<br>board. | Proprietary TCP/IP protocol | Proprietary TCP/IP protocol |
| Software functions (on PC) | Graphical user interface (GUI)<br>to control the machine,<br>TCP/IP communication, image<br>acquisition and correction;<br>image reconstruction. | Graphical user interface (GUI)<br>to control the machine, TCP/IP<br>communication, image<br>acquisition and correction |

| Rev. n. 2 | X-MIND prime 510(k) Abbreviated | VOL. 004 |
|------------|---------------------------------|---------------|
| 01/02/2021 | | Page 15 of 24 |

{18}------------------------------------------------

ACTEON

VOL. 004

001_Summary

## 510(k) Summary

Via Roma, 45 21057 Olgiate Olona (VA)

Proposed device: Predicate device: X-MIND prime Rotograph Evo D Integration of the specific Integration of a proprietary detector manufacturer SDK; detector SDK; Image acquisition PC memory and disk space PC memory and disk space management and control. management and control. Correction functions for Correction functions are detector are designed by Image correction (defect map, designed by Acteon / Owandy. Acteon / Owandy. Offset offset and flat field) Offset correction is done before correction is done before each acquisition each acquisition The frames acquired by the detector in area mode after The detector acquires images the corrections, are directly in TDI mode, then the 2D examination programs' final elaborated with a shift and software applies the correction add procedure to form the image explained in the previous table final image emulating the TDI raw to form the final imaqe (Time Delay Integration) acquisition mode GUI provides basic image preprocessing capabilities that GUI provides basic image prethe user can enable or 2D examination programs' processing capabilities that the disable. By default they are image pre-processing user can enable or disable. By disabled. This procedure default they are disabled. applies to cephalometric images too Installation Telescopic column Yes Yes 110-240 V, 50/60 Hz 110-120 V, 50/60 Hz Power supply voltage Current rating 14 A 15 A

Table 8: Comparison between the proposed and the predicate device.

| Rev. n. 2 | X-MIND prime 510(k) Abbreviated | VOL. 004 |
|------------|---------------------------------|---------------|
| 01/02/2021 | | Page 16 of 24 |

{19}------------------------------------------------

| | Via Roma, 45 |
|--|--------------|
|--|--------------|

21057 Olgiate Olona (VA)

## X-MIND prime

VOL. 004

001_Summary

The following table is focused on the comparison between the proposed device and the reference device #1.

DENTIOIII series (DENTIOIII, DENTIOIII-S): it is taken in the version with cephalometric arm (DENTIOIII-S) as reference device #1, manufactured by HDX WILL CORP. and cleared by FDA with 510(k) number K181297. The proposed device and the reference device share the same digital acquisition sensor for the cephalometric examinations.

| | Proposed device:<br>X-MIND prime | Reference device #1:<br>DENTIOIII series (DENTIOIII,<br>DENTIOIII-S) |
|-----------------------------------------------|-----------------------------------------------------------------|----------------------------------------------------------------------|
| Panoramic / Cephalometric<br>imaging detector | | |
| Detector model | Xineos-2301 | Xineos-2301 |
| Manufacturer | Teledyne DALSA | Teledyne DALSA |
| Technology | CMOS flat panel with Cesium<br>Iodide (CsI) scintillator screen | CMOS flat panel with Cesium<br>Iodide (CsI) scintillator screen |
| Sensor active area (Height x<br>Width) | 228 mm x 6.7 mm | 228 mm x 7.0 mm |
| Pixel size | 99 μm x 99 μm | 99 μm x 99 μm |
| Bit depth | 14 bit | 14 bit |
| Number of sensor pixels | 2304 x 68 | 2305 x 68 |
| MTF | 65% at 1 lp/mm | 65% at 1 lp/mm |
| DQE | 57% at 1 lp/mm | 57% at 1 lp/mm |
| Panoramic examination<br>programs | | |
| Panoramic exam time | 14 s | 14.2 s |

| Rev. n. 2 | X-MIND prime 510(k) Abbreviated | VOL. 004 |
|------------|---------------------------------|---------------|
| 01/02/2021 | | Page 17 of 24 |

{20}------------------------------------------------

ACTEON

VOL. 004

001_Summary

Via Roma, 45 21057 Olgiate Olona (VA) 510(k) Summary

| | Proposed device:<br>X-MIND prime | Reference device #1:<br>DENTIOIII series (DENTIOIII, DENTIOIII-S) |
|-------------------------------------------------|----------------------------------|-------------------------------------------------------------------|
| Panoramic exam | Yes | Yes |
| TMJ exam | Yes | Yes |
| Sinus exam | Yes | Yes |
| Cephalometric examination programs | | |
| Exam time | Max 15.1 s (HD) / min 4.4 s (HS) | Max 8.2 s (Normal) / 4.2 s (Fast) |
| Frontal (AP/PA) projection | Yes | Yes |
| Lateral (LL) projection | Yes | Yes |
| Carpus | Yes | Yes |
| Mechanical characteristics | | |
| Source to image distance in panoramic exams | 500 mm | 535 mm |
| Source to image distance in cephalometric exams | 1650 mm | 1735 mm (single detector type)<br>1729 mm (dual detector type) |
| Type of installation | Floor-Wall mount | Floor mount |
| Weight (wall mount version) | 118 kg | 160 kg |
| Dimensions (wall mount version) | 2229.5 mm x 1851 mm x 1205 mm | 2309 mm x 1953 mm x 1222 mm |

Table 9: Comparison between the proposed and the reference device #1.

| Rev. n. 2 | X-MIND prime 510(k) Abbreviated | VOL. 004 |
|------------|---------------------------------|---------------|
| 01/02/2021 | | Page 18 of 24 |

{21}------------------------------------------------

| X-MIND prime | |
|--------------|--|
|--------------|--|

VOL. 004

001_Summary

Via Roma, 45 21057 Olgiate Olona (VA)

To demonstrate that the quality of cephalometric images, acquired by X-MIND prime, is adequate for clinical purpose, we have provided a study evaluating images taken with proposed device performed by an independent reviewer graduated in Dentistry and Dental Prosthetics and Orthognathic

The following table is focused on the comparison between the proposed device and the reference device #2. X-MIND prime (Rotograph Prime) cleared with K162190

The proposed device and the reference device #2 share intended use excluded the cephalometric application and some technical details; moreover the reference device #2 has a Child specific panoramic exam with a shorter scan time as the proposed device.

To establish the equivalence of the image quality between the two devices we have performed a specific Performance Testing – Bench.

| | Proposed device:<br>X-MIND prime | Reference device #2:<br>Rotograph Prime |
|--------------------------------------------------------------------------|----------------------------------|-----------------------------------------|
| 2D Examination programs | | |
| Panoramic exam | Yes | Yes |
| Ortho Rad Panoramic | Yes | Yes |
| Segmented Panoramic (Half<br>panoramic, frontal dentition,<br>bitewings) | Yes | Yes |
| Low dose panoramic | Yes | Yes |
| TMJ Closed/Open mouth | Yes | Yes |
| TMJ single phase | Yes | Yes |
| Sinus | Yes | Yes |

| Rev. n. 2 | | VOL. 004 |
|------------|---------------------------------|---------------|
| 01/02/2021 | X-MIND prime 510(k) Abbreviated | Page 19 of 24 |

{22}------------------------------------------------

Image /page/22/Picture/0 description: The image shows the logo for ACTEON. The logo is in black and has a blue swoosh on the left side. The text is in all caps and is a bold sans-serif font.

VOL. 004

510(

Via Roma, 45 21057 Olgiate Olona (VA) 510(k) Summary

001_Summary

| | Proposed device:<br>X-MIND prime | Reference device #2:<br>Rotograph Prime |
|-----------------------------------------------------------------------------|-----------------------------------------------------|-----------------------------------------------------|
| 2D Examination<br>characteristics | | |
| Magnification (Panoramic) | 1.23 constant | 1.23 constant |
| Source to image distance<br>(panoramic) | 500 mm | 500 mm |
| Panoramic max image size | equivalent to 15x30 cm film | equivalent to 15x30 cm film |
| Adult panoramic scan time | 14 sec | 14.4 sec |
| Child panoramic exam with<br>shorter scan time than adult<br>panoramic exam | 12.8 sec | 13.3 sec |
| Patient positioning | | |
| Height adjustment | Motorized | Motorized |
| Positioning lights in panoramic<br>exams | 2 laser pointers | 2 laser pointers |
| Patient position | Standing | Standing |
| Patient positioning tools in<br>panoramic exams | Temple clamps, bite block,<br>chin support | Temple clamps, bite block, chin<br>support |
| Focal layer adjustment<br>(prognatism compensation) | Electronic, three positions, no<br>patient movement | Electronic, three positions, no<br>patient movement |
| Patient positioning orientation<br>vs the operator in panoramic<br>exams | Face to face | Face to face |
| Height of chin support from the<br>floor | 978-1678 mm | 975-1635 mm |

| Rev. n. 2 | X-MIND prime 510(k) Abbreviated | VOL. 004 |
|------------|---------------------------------|---------------|
| 01/02/2021 | | Page 20 of 24 |

{23}------------------------------------------------

| ACTEON<br>Via Roma, 45<br>21057 Olgiate Olona (VA) | X-MIND prime<br>510(k) Summary | VOL. 004<br>001_Summary |
|----------------------------------------------------|--------------------------------|-------------------------|
|----------------------------------------------------|--------------------------------|-------------------------|

| | Proposed device:<br>X-MIND prime | Reference device #2:<br>Rotograph Prime |
|----------------|-------------------------------------------------------|-------------------------------------------------------|
| User interface | | |
| PC connection | Dedicated Giga-Ethernet<br>channel | Ethernet connection |
| User interface | Onboard keyboard and virtual<br>control panel (on PC) | Onboard keyboard and virtual<br>control panel (on PC) |

Table 10: Comparison between the proposed and the reference device #2.

#### PERFORMANCE DATA AND TESTING EVIDENCE VII.

The following performance data are provided in support of the substantial equivalence determination.

Electrical safety and EMC testing were conducted on X-MIND prime.

The performance tests were conducted by a Nationally Recognized Testing Laboratory (NRTL) in order to verify:

- compliance with general requirements for basic safety and essential performance of . medical electrical equipment and dental extra-oral X-ray equipment
- . compliance with usability requirements
- compliance with electromagnetic compatibility requirements. .

| Rev. n. 2 | X-MIND prime 510(k) Abbreviated | VOL. 004 |
|------------|---------------------------------|---------------|
| 01/02/2021 | | Page 21 of 24 |

{24}------------------------------------------------

Image /page/24/Picture/0 description: The image shows the logo for ACTEON, a company whose name is written in bold, sans-serif font. A blue swoosh underlines the name. Below the logo is the text "Via Roma, 45" indicating an address.

VOL. 004

y

21057 Olgiate Olona (VA)

510(k) Summary

001_Summary

The following table shows the standards to which X-MIND prime complies, compared to those related predicated device Rotograph Evo D:

| Applied standards | |
|--------------------------------------------------------|--------------------------------------------------------|
| Proposed device:<br>X-MIND prime | Predicate device:<br>Rotograph Evo D |
| IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2<br>(2007) | IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2<br>(2007) |
| IEC 60601-1-2:2014 | IEC 60601-1-2:2007 |
| IEC 60601-1-3:2013 | IEC 60601-1-3:2008 |
| IEC 60601-2-63:2017 | IEC 60601-2-63:2012 |
| IEC 62304:2015 | IEC 62304:2006 |
| ES60601-1: 2005/(R)2012 and A1:2012 | ANSI/AAMI ES60601-1: 2005 / A2:2010 |
| CAN/CSA-C22.2 No. 60601-1:08 | CAN/CSA-C22.2 No. 60601-1:08 |
| IEC 60601-1-6:2013 | IEC 60601-1-6:2010 |
| IEC 62366-1:2015 | IEC 62366:2007 |
| ISO 10993-1:2010 | |
| ISO 10993-2:2006 | |
| ISO 10993-5:2009 | |
| ISO 10993-10:2010 | |
| ISO 10993-12:2012 | |

To assess the quality of the child panoramic images acquired with the proposed device X-MIND prime (PAN/CEPH version) and the reference device#2: Rotograph Prime (PAN version) in order to establish

| Rev. n. 2 | X-MIND prime 510(k) Abbreviated | VOL. 004 |
|------------|---------------------------------|----------|
| 01/02/2021 | Page 22 of 24 | |

{25}------------------------------------------------

Image /page/25/Picture/0 description: The image shows the logo for Acteon. The logo features the company name in bold, sans-serif font, with the letters "ACTEON" clearly visible. A stylized, curved graphic element in a light blue color is positioned to the left of the company name, adding a visual accent to the logo.

001_Summary

Via Roma, 45 21057 Olgiate Olona (VA)

the equivalence of the image quality between the two devices we have performed a specific bench test

X-MIND prime has been tested according to approved verification protocols to assure its conformity to the following parts of USA Code of Federal Requlations relating to PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS USA:

21 CFR §1020.30 Diagnostic x-ray systems and their major components.

21 CFR §1020.31 Radiographic equipment.

#### FDA GUIDANCE DOCUMENTS VIII.

Here below is shown the list of FDA quidance documents that X-MIND prime conforms to or that we referred during the development

- FDA Guidance for Industry and FDA Staff Format for Traditional and Abbreviated 510(k)s ● dated September 2019
- . FDA Guideline Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"dated September 2020
- FDA Guideline Recomended Content and format of complete Test reports for NOn-ClinicalBench performance Testing in 510K submission dated December 2019.
- FDA Guidance for "Pediatric Information for X-ray Imaging Device Premarket Notifications" ● dated November 2017
- . FDA Guidance for the content of premarket submissions for software contained in medical devices dated May 2005
- . FDA Guidance Content of premarket submission for management of cybersecurity October, 2014

#### IX. CONCLUSION

X-MIND prime has the same indication for use as the predicate and reference device #1. It is based on well-known technology. It shares the same technological characteristics as the predicate and reference devices. It has been tested on the basis of recognized standards and special controls 21 CFR §1020.30, 21 CFR §1020.31.

Minor technological differences,

given results of risk analysis of the changes of X-MIND prime with cephalometric option respect to the predicate device

| Rev. n. 2 | X-MIND prime 510(k) Abbreviated | VOL. 004 |
|------------|---------------------------------|---------------|
| 01/02/2021 | | Page 23 of 24 |

{26}------------------------------------------------

| ACTEON | X-MIND prime |
|--------------------------|----------------|
| Via Roma, 45 | 510(k) Summary |
| 21057 Olgiate Olona (VA) | VOL. 004 |
| | 001_Summary |

given results of performance bench with reference device #2,

do not raise any new questions regarding safety or effectiveness of the device, so it is as safe and effective as the predicate device.

| Rev. n. 2 | X-MIND prime 510(k) Abbreviated | VOL. 004 |
|------------|---------------------------------|---------------|
| 01/02/2021 | | Page 24 of 24 |