Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard image processing techniques (shift and add, Feldkamp algorithm, MAR algorithm) and basic image pre-processing capabilities, but does not mention AI or ML.

Therapeutic

No.
The device is an extra-oral dental panoramic and CBCT X-ray unit used for diagnostic imaging of dental and oral structures, not for therapeutic purposes.

Diagnostic

Yes
Explanation: The device is an X-ray unit used to take radiographic exams of teeth, jaw, oral structures, cranial, and wrist, and the output is used by healthcare professionals for analysis, which are all activities associated with diagnosing conditions. The text explicitly states it performs "radiographic analysis of the maxillo-facial complex."

SaMD (Software as a Medical Device)

No

The device is an X-ray unit, which is a hardware device that emits ionizing radiation. While it includes software for image processing and control, it is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided text, the X-MIND prime 3D is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
X-MIND prime 3D Function: The X-MIND prime 3D is an X-ray imaging device. It takes radiographic images of the internal structures of the body (teeth, jaw, skull, etc.) using X-rays. It does not analyze specimens taken from the body.

The text clearly describes the device as an "extra-oral dental panoramic and CBCT (aka CBVT) X-ray unit" that takes "radiographic exams." This aligns with the definition of a medical imaging device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

X-MIND prime 3D (and I-MAX 3D under trademark Owandy Radiology) is an extra-oral dental panoramic and CBCT (aka CBVT) X-ray unit to take either two dimensional (panoramic, TMJ and sinus exams) or three dimensional radiographic exams of teeth, jaw and oral structures. 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.

Two dimensional images are taken using the narrow beam technique. Three dimensional exams are taken using cone shaped X-ray beam technique; both of them are well known techniques.

Product codes

OAS, MUH

Device Description

X-MIND prime 3D is an X-ray device for the radiographic analysis of the maxillo-facial complex. X-MIND prime 3D performs 2D Panoramic, Half-panoramic, Low dose Panoramic, Frontal dentition, Ortho Rad Panoramic, Bitewing Bilateral, Bitewing Right, 2D Sinus and 2D TMJ, 3D Dentition with multiple available FOV centered in different areas of the maxillo-facial complex (Full Dentition, Maxillary Jaw, Mandibular Jaw, Maxillary Teeth, Mandibular Teeth), 3D Sinus, 3D TMJ, AP and LL cephalometric exams, Carpus exam.

This significant change mostly consists in the addition of the cephalometric arm to X-MIND prime 3D, as shown in overview figure below:

X-MIND prime 3D device consists of the following parts:

Control panel: The control panel provides an intuitive overview of the system and hold the keys to move up and down the column, turn on and off the positioning lasers and reset the device to the start exam position.
Detector group: It contains the PAN/ CBCT detector for use in generating radiographic images of the maxillo-facial region. The same detector is used to acquire 2D panoramic and CBCT exams.
Fixed arm: It supports the rotating arm.
Telescopic Column: The telescopic column supports and moves the entire structure of the medical device. In the version without CEPH arm it is fixed to the wall without any footrest; in the version with CEPH arm it is fixed to the wall and resting on the floor.
Patient handgrip: Handgrips held by the patient during the exam.
Patient support: The patient support allows to stabilise and immobilise the patient. It is equipped with tools to position the patient head to fit the patient's anatomy to the Field of View (FOV).
X-ray generator: The X-ray assembly is the source of the X-ray beam during the exams. The beam is modelled by a collimator; the electronic control ensures precision and accuracy of selected loading factors (kVp and anodic current). The tubehead aluminium additional filtration fits the CFR 21 part 1020.30 and remove low-energy ionising radiations, obtaining suitable radiation quality while reducing the dose absorbed by the patient.
Rotating arm: The rotating arm supports detectors and X-ray generator. This is the rotating part of the medical device, which moves around the patient during the image acquisition phase of panoramic / 3D exams.
CEPH arm: In the version of X-MIND prime 3D with cephalometric arm, it allows the execution of cephalometric exams: radiographic images of the patient skull in LL and AP views and of the patient's wrist to evaluate the bone growth (using the carpus plate provided with the cephalometric function).
CEPH craniostat: The craniostat is the patient positioning aiming device (composed by ear and nasion rest) for the cephalometric exams.
CEPH 2ry collimator: The CEPH 2ry collimator is translating during X-Rays in sync with CEPH detector and 1ry collimator (to collimate on CEPH detector the X-Ray beam emerging from the generator).
CEPH detector: The CEPH detector is translating during X-Rays in sync with CEPH 2ry collimator and 1ry collimator (to generate radiographic images of the patient skull in LL and AP views and of the patient's wrist.

Mentions image processing

Yes

Mentions AI, DNN, or ML

No

Input Imaging Modality

X-ray, Cone Beam Computed Tomography (CBCT)

Anatomical Site

teeth, jaw, oral structures, cranial, wrist

Indicated Patient Age Range

adults and pediatric patients from 7 years old [~27 kg (59.5 lb); 125 cm (49.2 in) standing height].

Intended User / Care Setting

dentists, radiologists and other legally qualified health care professionals, i.e. Prescription Use (Part 21 CFR 801 Subpart D).

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Electrical safety and EMC testing were conducted on X-MIND prime 3D. 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.

X-MIND prime 3D has been tested according to approved verification protocols to assure its conformity to the following parts of USA Code of Federal Regulations 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.
21 CFR §1020.33 Computed tomography (CT) equipment.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K180601, K181297

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
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.(b)
Classification. Class II.

Summary

0

November 18, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K201382

Trade/Device Name: X-MIND prime 3D (under trademark Acteon) I-MAX 3D (under trademark Owandy Radiology) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: OAS, MUH Dated: October 8, 2020 Received: October 13, 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) K201382

Device Name

X-MIND prime 3D (under trademark Acteon) I-MAX 3D (under trademark Owandy Radiology)

Indications for Use (Describe)

X-MIND prime 3D (and I-MAX 3D under trademark Owandy Radiology) is an extra-oral dental panoramic and CBCT (aka CBVT) X-ray unit to take either two dimensional (panoramic, TMI and sinus exams) or three dimensional radiographic exams of teeth, jaw and oral structures. 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.

Two dimensional images are taken using the narrow beam technique. Three dimensional exams are taken using cone shaped X-ray beam technique; both of them are well known techniques.

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

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3

ACTEON Logo

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

21057 Olgiate Olona (VA)

X-MIND prime 3D

VOL. 004

001_Summary

510(k) Summary

K201382

Index

I.	SUBMITTER	2
II.	PROPOSED DEVICE	2
III.	PREDICATE DEVICES	2
IV.	DEVICE DESCRIPTION	3
V.	INDICATIONS FOR USE	9
VI.	COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE
DEVICES	9
VII.	PERFORMANCE DATA AND TESTING EVIDENCE.	21
VIII	CONCLUSION	23

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VOL. 004

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:	+39 0331 376760
Fax:	+39 0331 376763
Contact person:	Dario Bandiera – dario.bandiera@acteongroup.com
Date:	September 15th, 2020

Table 1: Submitter information

PROPOSED DEVICE II.

| Name of the device: | X-MIND prime 3D (under trademark Acteon)
I-MAX 3D (under trademark Owandy Radiology) |
|-----------------------|-----------------------------------------------------------------------------------------|
| Common or Usual name: | Dental panoramic, cephalometric and CBCT X-ray system |
| Classification name: | Computed tomography X-ray system (21 CFR 892.1750) |
| Regulatory class: | II |
| Product Code: | OAS |

Table 2: Proposed device information

PREDICATE DEVICES III.

Legally marketed devices to which equivalence is claimed is:

PRIMARY PREDICATE DEVICE
Device name	X-MIND prime 3D
Manufacturer	de Götzen S.r.l. – ACTEON Group
Device product code	OAS
Regulation number	892.1750
Regulation name	Computed tomography x-ray system
Clearance date	November 2nd, 2018
510(k) number	K180601

Table 3: Primary predicate device information

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VOL. 004

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

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

Table 4: Additional predicate device information

DEVICE DESCRIPTION IV.

NOTE: In the following, all the reference to X-MIND prime 3D are applicable also to I-MAX 3D under trademark Owandy Radiology

X-MIND prime 3D is an X-ray device for the radiographic analysis of the maxillo-facial complex. X-MIND prime 3D performs 2D Panoramic, Half-panoramic, Low dose Panoramic, Frontal dentition, Ortho Rad Panoramic, Bitewing Bilateral, Bitewing Right, 2D Sinus and 2D TMJ, 3D Dentition with multiple available FOV centered in different areas of the maxillo-facial complex (Full Dentition, Maxillary Jaw, Mandibular Jaw, Maxillary Teeth, Mandibular Teeth), 3D Sinus, 3D TMJ, AP and LL cephalometric exams, Carpus exam.

X-MIND prime 3D 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 kq (55 lb); 125 cm (49.2 in) standing height]. Anyway, the sustainability to X-ray exposure must be evaluated by surgeons, dentists and qualified and authorized physicians
Patient status: .
- self-sufficient patient (the patient can autonomously place himself as requested by · the physician)
- . non self-sufficient patient (the patient is assisted by medical personnel)
- in any case the patient must be conscious, not anaesthetized and not incapacitated
. Nationality: multiple.

OVERVIEW OF THE DEVICE

The reason of the present submission is the introduction of a significative change on X-MIND prime 3D device (listing number D342123 and FDA clearance K180601).

This significant change mostly consists in the addition of the cephalometric arm to X-MIND prime 3D, as shown in overview figure below:

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Image /page/6/Picture/0 description: The image shows a document with the title "X-MIND prime 3D 510(k) Summary". The document also includes the volume number "VOL. 004" and the summary number "001_Summary". The document also includes the address "Via Roma, 45 21057 Olgiate Olona (VA)" and the ACTEON logo.

Image /page/6/Figure/1 description: The image shows two X-MIND prime 3D machines, one without a CEPH arm and one with a CEPH arm. Both machines have several labeled parts, including the base, the arm, and the head. The machine with the CEPH arm has additional labeled parts related to the CEPH arm, such as the sensor and the support.

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

| 1 | Control panel | The control panel provides an intuitive overview of the system
and hold the keys to move up and down the column, turn on and
off the positioning lasers and reset the device to the start exam
position.
Image: Control Panel |
|---|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2 | Detector group | It contains the PAN/ CBCT detector for use in generating
radiographic images of the maxillo-facial region. The same
detector is used to acquire 2D panoramic and CBCT exams. |
| 3 | Fixed arm | It supports the rotating arm. |
| 4 | Telescopic Column | The telescopic column supports and moves the entire structure of
the medical device.
In the version without CEPH arm it is fixed to the wall without any
footrest; |

						X-MIND prime 3D device consists of the following parts:
--	--	--	--	--	--	---------------------------------------------------------	--

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Image /page/7/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 "ACTEON" is in all caps and is bolded.

VOL. 004

001_Summary

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

| | | in the version with CEPH arm it is fixed to the wall and resting on
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.
It is equipped with tools to position the patient head to fit the
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
exams. The beam is modelled by a collimator; the electronic
control ensures precision and accuracy of selected loading factors
(kVp and anodic current). The tubehead aluminium additional
filtration fits the CFR 21 part 1020.30 and remove low-energy
ionising radiations, obtaining suitable radiation quality while
reducing the dose absorbed by the patient. | |
| 8 | Rotating arm | The rotating arm supports detectors and X-ray generator. This is
the rotating part of the medical device, which moves around the
patient during the image acquisition phase of panoramic / 3D
exams. | |
| 9 | CEPH arm | In the version of X-MIND prime 3D with cephalometric arm, it
allows the execution of cephalometric exams: radiographic
images of the patient skull in LL and AP views and of the patient's
wrist to evaluate the bone growth (using the carpus plate
provided with the cephalometric function). | |
| 10 | CEPH craniostat | The craniostat is the patient positioning aiming device (composed
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
CEPH detector and 1ry collimator (to collimate on CEPH detector
the X-Ray beam emerging from the generator). | |
| 12 | CEPH detector | The CEPH detector is translating during X-Rays in sync with CEPH
2ry collimator and 1ry collimator (to generate radiographic images
of the patient skull in LL and AP views and of the patient's wrist. | |

Table 5: X-MIND prime 3D parts

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Via Roma, 45 21057 Olgiate Olona (VA)

510(k) Summary

EQUIPMENT CONFIGURATIONS

X-MIND prime 3D can be sold in these different configurations:

PAN / CBCT

In this configuration, X-MIND prime 3D is equipped only with the PAN/CBCT detector which allows to acquire both panoramic and CBCT exams.

PAN / CBCT / CEPH

The equipment can carry out the panoramic, 3D and cephalometric exams.

The device is equipped with a PAV/CBCT detector which allows to acquire both panoramic and CBCT exams.

On the cephalometric arm, a dedicated CEPH detector allows the acquisition of the cephalometric exams.

LIST OF EXAMS

X-MIND prime 3D is a complete panoramic X-ray system that can perform the followinq 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,

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Via Roma, 45 21057 Olgiate Olona (VA)

joining them on the same image

3D examination programs

. 3D Full Dentition (FOV 85 x 93 mm): 3D exam of the full dentition
. 3D Single Jaw (FOV 85 x 50 mm): 3D exam of a single dental arc with two different FOV positions: Maxillary, Mandibular
3D Mandibular Teeth (FOV 50 x 50 mm): 3D exam of a reduced part of the mandibular dentition, with five different FOV positions: Frontal, Premolars (right/left) and Molars (right/left)
3D Maxillary Teeth (FOV 50 x 50 mm): 3D exam of a reduced part of the maxillary dentition, with . five different FOV positions: Frontal, Premolars (right/left) and Molars (right/left)
3D TM| (FOV 85 x 93 mm): 3D exam of the temporomandibular joint with two different FOV . positions (right/left)
. 3D Sinus (FOV 85 x 93 mm): 3D exam of the maxillary sinuses area

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 preset 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/CBCT, CEPH) are the most important parts of the X-MIND prime 3D device and allow the acquisition of the radiographic images of the maxillofacial complex. The PAN/CBCT detector and the X-ray source are mounted on the rotating arm of the device, while the CEPH detector is mounted on the cephalometric arm.

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001_Summary

510(k) Summary

Via Roma, 45 21057 Olgiate Olona (VA)

During the panoramic and CBCT 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 image (panoramic) or 3D reconstruction of the target volume.

In order to acquire the cephalometric exams, the CEPH detector performs a horizontal linear scanning of the skull, while the focus is kept in a fixed position, quaranteeing 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.

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11

21057 Olgiate Olona (VA)

Via Roma, 45

X-MIND prime 3D

510(k) Summary

V. INDICATIONS FOR USE

X-MIND prime 3D (and I-MAX 3D under trademark Owandy Radiology) is an extra-oral dental panoramic and CBCT (aka CBVT) X-ray unit to take either two dimensional (panoramic, TM) and sinus exams) or three dimensional radiographic exams of teeth, jaw and oral structures. 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.

Two dimensional images are taken using the narrow beam technique. Three dimensional exams are taken using cone shaped X-ray beam technique; both of them are well known techniques.

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 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.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VI. DEVICES

NOTE: In the following, all the reference to X-MIND prime 3D are applicable also to I-MAX 3D under trademark Owandy Radiology

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| | Proposed device:
X-MIND prime 3D | Primary predicate device:
Rotograph Prime 3D | Additional predicate
device:
DENTIOIII series
(DENTIOIII, DENTIOIII-S) |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | X-MIND prime 3D is an
extra-oral dental
panoramic and CBCT (aka
CBVT) X-ray unit to take
either two dimensional
(panoramic, TMJ and sinus
exams) or three
dimensional radiographic
exams of teeth, jaw and
oral structures. 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. | Rotograph Prime 3D is an
extra-oral dental
panoramic and CBCT (aka
CBVT) X-ray unit to take
either two dimensional
(panoramic, TMJ and sinus
exams) or three
dimensional radiographic
exams of teeth, jaw and
oral structures. | The DENTIOIII series is
intended for dental
radiographic examination
of the teeth and
temporomandibular joints,
specifically for panoramic
and cephalometric
examinations. It is to be
used only by dental
practitioners and/or
radiologists |

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| Proposed device:
X-MIND prime 3D | Primary predicate device:
Rotograph Prime 3D | Additional predicate
device:
DENTIOIII series
(DENTIOIII, DENTIOIII-S) |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Two dimensional images
are taken using the narrow
beam technique. Three
dimensional exams are
taken using cone shaped X-
ray beam technique; both
of them are well known
techniques.
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. | Two dimensional images
are taken using the narrow
beam technique. Three
dimensional exams are
taken using cone shaped X-
ray beam technique; both
of them are well known
techniques.
The device is operated and
used by dentists,
radiologists and other
legally qualified health care
professionals.
It can be used with both
pediatric and adult
patients. | |

Table 6: Comparison of the intended use among proposed and predicate devices.

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Image /page/14/Picture/12 description: The image shows the logo for Acteon. The logo features the word "ACTEON" in bold, sans-serif font. A blue swoosh design is located to the left of the word, adding a visual element to the logo. The logo is simple and modern in design.

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Detailed comparison of similarities and differences

The following table highlights the existing similarities for 2D and 3D exams between the proposed device and the primary predicate device.

| | Proposed device:
X-MIND prime 3D | Primary predicate device:
X-MIND prime 3D
(Rotograph Prime 3D) |
|-----------------------------------------------------------------------------|-------------------------------------|----------------------------------------------------------------------|
| 2D Examination programs | | |
| Panoramic exam | Yes | Yes |
| Ortho Rad Panoramic | Yes | Yes |
| Segmented Panoramic (Half
panoramic, frontal dentition,
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) | 1.28 constant | 1.28 constant |
| Source to image distance | 520 mm | 520 mm |
| Panoramic max image size | equivalent to 15x30 cm film | equivalent to 15x30 cm film |
| Adult panoramic scan time | 14 s | 14 s |
| Child panoramic exam with
shorter scan time than adult
panoramic exam | 12.8 s | 12.8 s |

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| | Proposed device:
X-MIND prime 3D | Primary predicate device:
X-MIND prime 3D
(Rotograph Prime 3D) |
|-------------------------------------------|-------------------------------------|----------------------------------------------------------------------|
| 3D examination programs | | |
| 3D Full dentition | Yes | Yes |
| 3D TMJ Left | Yes | Yes |
| 3D TMJ Right | Yes | Yes |
| 3D Sinus | Yes | Yes |
| 3D Single Jaw
(maxillary / mandibular) | Yes | Yes |
| 3D teeth only (maxillary /
mandibular) | Yes | Yes |
| 3D High resolution mode | Yes | Yes |
| 3D exam characteristics | | |

3D exam characteristics
X-ray beam	Cone Beam	Cone Beam
Acquisition trajectory	Single 200 degree rotation
(except for 3D TMJ)
Single 180 degree rotation
(for 3D TMJ)	Single 200 degree rotation
(except for 3D TMJ)
Single 180 degree rotation (for
3D TMJ)
Rotation time	20 s (except for 3D TMJ)
18 s (for 3D TMJ)	20 s (except for 3D TMJ)
18 s (for 3D TMJ)
X-ray emission method	Pulsed	Pulsed
Reconstruction algorithm	Feldkamp with the option of
MAR (Metal Artifact Removal)	Feldkamp with the option of
MAR (Metal Artifact Removal)

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| | Proposed device:
X-MIND prime 3D | Primary predicate device:
X-MIND prime 3D
(Rotograph Prime 3D) |
|-------------------------------------------------------------------------------------------|-----------------------------------------------------------------|----------------------------------------------------------------------|
| Magnification | 1.37 | 1.37 |
| Source to image distance | 520 mm | 520 mm |
| X-ray emission time | 6.2 - 7 s | 6.2 - 7 s |
| Biggest FOV (Ø x H) mm (3D
dentition, 3D TMJs, 3D sinus) | 85 mm x 93 mm | 85 mm x 93 mm |
| Size of acquired voxel (isotropic) | 175 µm | 175 µm |
| Size of acquired voxel in High
resolution mode (isotropic),
available on Other FOVs | 87.5 µm | 87.5 µm |
| 2D/3D imaging detector | | |
| Technology | CMOS flat panel with Cesium
Iodide (CsI) scintillator screen | CMOS flat panel with Cesium
Iodide (CsI) scintillator screen |
| Sensor active area (Height x
Width) | 144 x 118.6 mm | 144 x 118.6 mm |
| Pixel size | 120 µm x 120 µm | 120 µm x 120 µm |
| Bit depth | 16 bit | 16 bit |
| Number of sensor pixels | 1200 x 988 | 1200 x 988 |
| Generator/tube
characteristics | | |
| X-ray generator | High frequency | High frequency |
| Focal spot value | 0.5 mm (IEC 60336) | 0.5 mm (IEC 60336) |

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| | Proposed device:
X-MIND prime 3D | Primary predicate device:
X-MIND prime 3D
(Rotograph Prime 3D) |
|-----------------------------------------------------|---------------------------------------------------------|----------------------------------------------------------------------|
| Anode type | Fixed | Fixed |
| X-ray exposure time control | Automatic - pre-programmed
Microprocessor Controlled | Automatic – pre-programmed
Microprocessor Controlled |
| Independent kV-mA regulation | Yes | Yes |
| DAP Software | Yes | Yes |
| kV Range | 60 - 86 kV step 2kV | 60 - 86 kV step 2kV |
| Total filtration | ≥ 2.5 mm Al eq | ≥ 2.5 mm Al eq |
| mA range | 2 - 12.5 mA | 2 - 12.5 mA |
| Collimator | Automatic | Automatic |
| Patient positioning for
panoramic and 3D exams | | |
| 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, head strip | Temple clamps, bite block, chin
support, head strip |
| Focal layer adjustment
(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 |

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| | Proposed device:
X-MIND prime 3D | Primary predicate device:
X-MIND prime 3D
(Rotograph Prime 3D) |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Height of chin support from the
floor | 978-1678 mm | 975-1635 mm |
| User interface | | |
| Real time visualization | Yes | Yes |
| PC connection | Two dedicated Giga-Ethernet
channels: one for the machine
communication and for the
ceph detector, the second
dedicated to the PAN/3D
detector | Ethernet for the machine
communication + point to point
dedicated giga-ethernet for the
detector |
| User interface | Onboard keyboard and virtual
control panel (on PC) | Onboard keyboard and virtual
control panel (on PC) |
| Software | | |
| System architecture | Based on multiple CPUs
connected via Can Bus plus
Ethernet connection to PC | Based on multiple CPUs
connected via Can Bus plus
Ethernet connection to PC. |

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| | Proposed device:
X-MIND prime 3D | Primary predicate device:
X-MIND prime 3D
(Rotograph Prime 3D) |
|------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Firmware functions
(of Control Processing Units) for
controlling movements and
image
acquisition/synchronization | Firmware functions are
designed to manage the
panoramic/3D version and
the cephalometric option.
Some differences in the
firmware functions are
related to the management of
the added cephalometric
option. Some additional
differences are related to
specific hardware solutions or
different microprocessors
from the Primary Predicate
Device. | Firmware functions are
designed to manage the
following configuration:
panoramic/3D version |
| X-ray generator board firmware
functions | X-ray parameters (kV, mA,
pulsed / continuous emission)
management, X-ray start and
stop, errors control.
Can Bus communication. | X-ray parameters (kV, mA,
pulsed / continuous emission)
management, X-ray start and
stop, errors control.
Can Bus communication. |
| Communication protocol
between the computer and
Controlling Processing Unit
board. | Proprietary TCP/IP protocol | Proprietary TCP/IP protocol |
| Software functions (on PC) | Graphical user interface (GUI)
to control the machine,
TCP/IP communication, image
acquisition and correction;
image reconstruction. | Graphical user interface (GUI)
to control the machine, TCP/IP
communication, image
acquisition and correction;
image reconstruction |

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| | Proposed device:
X-MIND prime 3D | Primary predicate device:
X-MIND prime 3D
(Rotograph Prime 3D) |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image acquisition | Integration of the specific
detector manufacturer SDK;
PC memory and disk space
management and control. | Integration of the specific
detector manufacturer SDK; PC
memory and disk space
management and control. |
| Image correction (defect map,
offset and flat field) | Correction functions for
detector are designed by
Acteon / Owandy. Offset
correction is done before
each acquisition | Correction functions for
detector are designed by
Acteon / Owandy. Offset
correction is done before
each acquisition |
| 2D examination programs' final
image | The frames acquired by the
Flat panel detector in area
mode after the corrections,
are elaborated with a shift
and add procedure to form
the final image. This
procedure applies to
cephalometric images too | The frames acquired by the Flat
panel detector in area mode are
after the correction, are
elaborated with a shift and add
procedure to form the final
image |
| 2D examination programs'
image pre-processing | GUI provides basic image pre-
processing capabilities that
the user can enable or
disable. By default they are
disabled. This procedure
applies to cephalometric
images too | GUI provides basic image pre-
processing capabilities that the
user can enable or disable. By
default they are disabled. |

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| | Proposed device:
X-MIND prime 3D | Primary predicate device:
X-MIND prime 3D
(Rotograph Prime 3D) |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 3D examination image
reconstruction | The frames acquired by the
Flat panel detector in area
mode after the correction, are
elaborated with a Feldkamp
algorithm -and eventually
with the MAR algorithm- to
get a set of axial slices; then a
dicom header is added to
each slice file. Dicom dataset
is then saved to disk for
transfer to external
visualization/processing
programs.
The 3D reconstruction is done
using PC GPU or CPU. | The frames acquired by the Flat
panel detector in area mode
after the correction, are
elaborated with a Feldkamp
algorithm -and eventually with
the MAR algorithm- to get a set
of axial slices; then a dicom
header is added to each slice
file. Dicom dataset is then
saved to disk for transfer to
external
visualization/processing
programs.
The 3D reconstruction is done
using PC CPU. |
| Installation | | |
| Telescopic column | Yes | Yes |
| Power supply voltage | 110-240 V, 50/60 Hz | 110-240 V, 50/60 Hz |
| Current rating | 14 A | 14.5 A |

Table 7: Comparison between the proposed and the primary predicate device.

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510(k) Summary

The following table is focused on the comparison about the cephalometric exams between the proposed device and the additional predicate device.

| | Proposed device:
X-MIND prime 3D | Additional predicate device:
DENTIOIII series (DENTIOIII,
DENTIOIII-S) |
|----------------------------------------|-----------------------------------------------------------------|------------------------------------------------------------------------------|
| Cephalometric imaging
detector | | |
| Detector model | Xineos-2301 | Xineos-2301 |
| Manufacturer | Teledyne DALSA | Teledyne DALSA |
| Technology | CMOS flat panel with Cesium
Iodide (CsI) scintillator screen | CMOS flat panel with Cesium
Iodide (CsI) scintillator screen |
| Sensor active area (Height x
Width) | 228 mm x 6.7 mm | 228 mm x 7.0 mm |
| Pixel size | 99 $\mu$ m x 99 $\mu$ m | 99 $\mu$ m x 99 $\mu$ m |
| 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 |
| 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 |

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Additional predicate device: Proposed device: DENTIOIII series (DENTIOIII, X-MIND prime 3D DENTIOIII-S) Carpus Yes Yes Mechanical characteristics 1735 mm (single detector type) 1650 mm Source to image distance 1729 mm (dual detector type) Floor-Wall or Floor mount Type of installation Floor mount Weight (wall mount version) 123 kg 160 kg 2229.5 mm x 1851 mm x 1205 Dimensions (wall mount 2309 mm x 1953 mm x 1222 version) mm mm

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

The differences between the proposed device and the predicate devices do not raise new questions of safety and effectiveness.

VII. PERFORMANCE DATA AND TESTING EVIDENCE

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

Electrical safety and EMC testing were conducted on X-MIND prime 3D. 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.

The following table shows the standards to which X-MIND prime 3D complies, compared to those related primary predicated device X-MIND prime 3D:

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Image /page/24/Picture/0 description: The image shows the logo for Acteon. The logo consists of the word "ACTEON" in bold, black letters. A blue curved line is located to the left of the word, starting below the "A" and extending upwards and to the left.

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| Applied standards | Proposed device:
X-MIND prime 3D | Primary predicate device:
X-MIND prime 3D
(Rotograph Prime 3D) |
|-------------------|--------------------------------------------------------|----------------------------------------------------------------------|
| | IEC 60601-1: 2005 + CORR. 1
(2006) + CORR. 2 (2007) | IEC 60601-1: 2005 + CORR. 1
(2006) + CORR. 2 (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 10993-1:2010 |
| | ISO 10993-2:2006 | ISO 10993-2:2006 |
| | ISO 10993-5:2009 | ISO 10993-5:2009 |
| | ISO 10993-10:2010 | ISO 10993-10:2010 |
| | ISO 10993-12:2012 | ISO 10993-12:2012 |

X-MIND prime 3D has been tested according to approved verification protocols to assure its conformity to the following parts of USA Code of Federal Regulations relating to PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS USA:

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

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Image /page/25/Picture/0 description: The image shows the logo for Acteon, which is a stylized wordmark with a blue swoosh above the letters. Below the logo is the text "Via Roma, 45" followed by "21057 Olgiate Olona (VA)". This text likely represents the address of the company or a location associated with Acteon. The address is located in Italy.

510(k) Summary

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510(k) Summary

21 CFR §1020.31 Radiographic equipment.

21 CFR §1020.33 Computed tomography (CT) equipment.

CONCLUSION VIII.

X-MIND prime 3D has the same indication for use as the predicate devices. It performs the same functions in the same environment as the predicate devices. It is based on well-known technology. It shares the same technological characteristics as the predicate devices. Minor technological differences do not raise any new questions regarding safety or effectiveness of the device, so it is as safe as effective as the predicate devices.

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