X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)
Device Facts
| Record ID | K201382 |
|---|---|
| Device Name | X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) |
| Applicant | De Gotzen S.R.L. |
| Product Code | OAS · Radiology |
| Decision Date | Nov 18, 2020 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 892.1750 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended 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, 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.
Device Story
X-MIND prime 3D is an extra-oral dental X-ray system for 2D panoramic, cephalometric, and 3D CBCT imaging. The device uses a high-frequency X-ray generator and a CMOS flat panel detector with a Cesium Iodide scintillator. For 3D exams, the rotating arm moves around the patient's head, acquiring images via a cone-shaped beam; for 2D panoramic and cephalometric exams, it uses a narrow beam technique. The system is operated by dentists or radiologists in a clinical setting. Output images are processed via a PC-based workstation using a Feldkamp reconstruction algorithm (with optional Metal Artifact Removal) for 3D, or shift-and-add procedures for 2D. The device aids clinicians in diagnosing dental and maxillofacial conditions. The addition of a cephalometric arm allows for skull and wrist (Carpus) imaging. The system includes motorized height adjustment, laser positioning, and patient support tools to ensure accurate alignment.
Clinical Evidence
Bench testing only. Performance data included electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and compliance with 21 CFR 1020.30, 1020.31, and 1020.33 for ionizing radiation-emitting products. No clinical data was required for this submission.
Technological Characteristics
High-frequency X-ray generator; CMOS flat panel detector with Cesium Iodide (CsI) scintillator; 0.5 mm focal spot (IEC 60336); 60-86 kV range; 2-12.5 mA range; motorized height adjustment; 2 laser pointers; Giga-Ethernet connectivity; software-based image reconstruction (Feldkamp algorithm); wall or floor mount configuration.
Indications for Use
Indicated for extra-oral dental panoramic, CBCT, and cephalometric radiographic exams of teeth, jaw, oral structures, and skull/wrist (Carpus) for bone growth evaluation. Patient population: adults and pediatric patients from 7 years old (~27 kg, 125 cm). Contraindicated if X-ray exposure is not deemed sustainable by a qualified physician.
Regulatory Classification
Identification
A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- X-MIND prime 3D (K180601)
- DENTIOIII Series (DENTIOIII, DENTIOIII-S) (K181297)
Related Devices
- K191719 — X-MIND Trium · De Gotzen S.R.L. · Feb 20, 2020
- K203374 — X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology) · De Götzen S.R.L. · Feb 5, 2021
- K160525 — RCT700 · Ray Co., Ltd. · Jun 20, 2016
- K160166 — X-MIND trium · De Gotzen S.R.L. · Nov 15, 2016
- K213579 — Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph · Fona S.R.L · Mar 2, 2022
Submission Summary (Full Text)
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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
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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
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#### 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) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg height="12" width="12"> <rect height="12" style="fill:none;stroke-width:2;stroke:rgb(0,0,0)" width="12"></rect> <line style="stroke:rgb(0,0,0);stroke-width:2" x1="0" x2="12" y1="0" y2="12"></line> <line style="stroke:rgb(0,0,0);stroke-width:2" x1="0" x2="12" y1="12" y2="0"></line> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
| <div> <span> <svg height="12" width="12"> <rect height="12" style="fill:none;stroke-width:2;stroke:rgb(0,0,0)" width="12"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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| Via Roma, 45 |
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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<br>DEVICES | 9 |
| VII. | PERFORMANCE DATA AND TESTING EVIDENCE. | 21 |
| VIII | CONCLUSION | 23 |
| Rev. n. 2 | | VOL. 004 |
|------------|------------------------------------|--------------|
| 08/10/2020 | X-MIND prime 3D 510(k) Abbreviated | Page 1 of 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)<br>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
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
|------------|------------------------------------|--------------|
| 08/10/2020 | | Page 2 of 23 |
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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:
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
|------------|------------------------------------|--------------|
| 08/10/2020 | | Page 3 of 23 |
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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<br>and hold the keys to move up and down the column, turn on and<br>off the positioning lasers and reset the device to the start exam<br>position.<br>Image: Control Panel |
|---|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2 | Detector group | It contains the PAN/ CBCT detector for use in generating<br>radiographic images of the maxillo-facial region. The same<br>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<br>the medical device.<br>In the version without CEPH arm it is fixed to the wall without any<br>footrest; |
| | | | | | | X-MIND prime 3D device consists of the following parts: | |
|--|--|--|--|--|--|---------------------------------------------------------|--|
|--|--|--|--|--|--|---------------------------------------------------------|--|
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
|------------|------------------------------------|--------------|
| 08/10/2020 | | Page 4 of 23 |
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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<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. | |
| 8 | Rotating arm | The rotating arm supports detectors and X-ray generator. This is<br>the rotating part of the medical device, which moves around the<br>patient during the image acquisition phase of panoramic / 3D<br>exams. | |
| 9 | CEPH arm | In the version of X-MIND prime 3D with cephalometric arm, it<br>allows the execution of cephalometric exams: radiographic<br>images of the patient skull in LL and AP views and of the patient's<br>wrist to evaluate the bone growth (using the carpus plate<br>provided with 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 | CEPH detector | The CEPH detector is translating during X-Rays in sync with CEPH<br>2ry collimator and 1ry collimator (to generate radiographic images<br>of the patient skull in LL and AP views and of the patient's wrist. | |
Table 5: X-MIND prime 3D parts
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
|------------|------------------------------------|--------------|
| 08/10/2020 | | Page 5 of 23 |
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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,
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
|------------|------------------------------------|--------------|
| 08/10/2020 | | Page 6 of 23 |
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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.
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
|------------|------------------------------------|--------------|
| 08/10/2020 | | Page 7 of 23 |
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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.
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
|------------|------------------------------------|--------------|
| 08/10/2020 | | Page 8 of 23 |
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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
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
|------------|------------------------------------|--------------|
| 08/10/2020 | | Page 9 of 23 |
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ACTIFO
# X-MIND prime 3D
VOL. 004
001_Summary
Via Roma, 45 21057 Olgiate Olona (VA)
| | Proposed device:<br>X-MIND prime 3D | Primary predicate device:<br>Rotograph Prime 3D | Additional predicate<br>device:<br>DENTIOIII series<br>(DENTIOIII, DENTIOIII-S) |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | X-MIND prime 3D is an<br>extra-oral dental<br>panoramic and CBCT (aka<br>CBVT) X-ray unit to take<br>either two dimensional<br>(panoramic, TMJ and sinus<br>exams) or three<br>dimensional radiographic<br>exams of teeth, jaw and<br>oral structures. The models<br>with cephalometric arm will<br>be able to take two<br>dimensional cranial<br>cephalometric exams in<br>different projections and<br>the wrist exam (Carpus)<br>dedicated to the evaluation<br>of the bone growth. | Rotograph Prime 3D is an<br>extra-oral dental<br>panoramic and CBCT (aka<br>CBVT) X-ray unit to take<br>either two dimensional<br>(panoramic, TMJ and sinus<br>exams) or three<br>dimensional radiographic<br>exams of teeth, jaw and<br>oral structures. | The DENTIOIII series is<br>intended for dental<br>radiographic examination<br>of the teeth and<br>temporomandibular joints,<br>specifically for panoramic<br>and cephalometric<br>examinations. It is to be<br>used only by dental<br>practitioners and/or<br>radiologists |
| Rev. n. 2 | | VOL. 004 |
|------------|------------------------------------|---------------|
| 08/10/2020 | X-MIND prime 3D 510(k) Abbreviated | Page 10 of 23 |
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Image /page/13/Picture/9 description: The image contains the logo for ACTEON. The logo is in black font with a blue swoosh on the left side. The font is bold and sans-serif.
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Via Roma, 45 21057 Olgiate Olona (VA) 510(k) Summary
| Proposed device:<br>X-MIND prime 3D | Primary predicate device:<br>Rotograph Prime 3D | Additional predicate<br>device:<br>DENTIOIII series<br>(DENTIOIII, DENTIOIII-S) |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Two dimensional images<br>are taken using the narrow<br>beam technique. Three<br>dimensional exams are<br>taken using cone shaped X-<br>ray beam technique; both<br>of them are well known<br>techniques.<br>The device is operated and<br>used by dentists,<br>radiologists and other<br>legally qualified health care<br>professionals, i.e.<br>Prescription Use (Part 21<br>CFR 801 Subpart D).<br>The target patient<br>population includes adults<br>and pediatric patients from<br>7 years old [~27 kg (59.5 lb);<br>125 cm (49.2 in) standing<br>height].<br>Anyway, the sustainability<br>to X-ray exposure must be<br>evaluated by surgeons,<br>dentists and qualified and<br>authorized physicians. | Two dimensional images<br>are taken using the narrow<br>beam technique. Three<br>dimensional exams are<br>taken using cone shaped X-<br>ray beam technique; both<br>of them are well known<br>techniques.<br>The device is operated and<br>used by dentists,<br>radiologists and other<br>legally qualified health care<br>professionals.<br>It can be used with both<br>pediatric and adult<br>patients. | |
Table 6: Comparison of the intended use among proposed and predicate devices.
| Rev.n. 2 | | VOL. 004 |
|------------|------------------------------------|---------------|
| 08/10/2020 | X-MIND prime 3D 510(k) Abbreviated | Page 11 of 23 |
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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.
VOL. 004
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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:<br>X-MIND prime 3D | Primary predicate device:<br>X-MIND prime 3D<br>(Rotograph Prime 3D) |
|-----------------------------------------------------------------------------|-------------------------------------|----------------------------------------------------------------------|
| 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) | 1.28 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<br>shorter scan time than adult<br>panoramic exam | 12.8 s | 12.8 s |
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
|------------|------------------------------------|---------------|
| 08/10/2020 | | Page 12 of 23 |
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ACTEON
## X-MIND prime 3D
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Via Roma, 45 21057 Olgiate Olona (VA)
| | Proposed device:<br>X-MIND prime 3D | Primary predicate device:<br>X-MIND prime 3D<br>(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<br>(maxillary / mandibular) | Yes | Yes |
| 3D teeth only (maxillary /<br>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<br>(except for 3D TMJ)<br>Single 180 degree rotation<br>(for 3D TMJ) | Single 200 degree rotation<br>(except for 3D TMJ)<br>Single 180 degree rotation (for<br>3D TMJ) |
| Rotation time | 20 s (except for 3D TMJ)<br>18 s (for 3D TMJ) | 20 s (except for 3D TMJ)<br>18 s (for 3D TMJ) |
| X-ray emission method | Pulsed | Pulsed |
| Reconstruction algorithm | Feldkamp with the option of<br>MAR (Metal Artifact Removal) | Feldkamp with the option of<br>MAR (Metal Artifact Removal) |
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
|------------|------------------------------------|----------|
| 08/10/2020 | Page 13 of 23 | |
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ACTIFON
## X-MIND prime 3D
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Via Roma, 45 21057 Olgiate Olona (VA)
| | Proposed device:<br>X-MIND prime 3D | Primary predicate device:<br>X-MIND prime 3D<br>(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<br>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<br>resolution mode (isotropic),<br>available on Other FOVs | 87.5 µm | 87.5 µm |
| 2D/3D imaging detector | | |
| 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) | 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<br>characteristics | | |
| X-ray generator | High frequency | High frequency |
| Focal spot value | 0.5 mm (IEC 60336) | 0.5 mm (IEC 60336) |
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
|------------|------------------------------------|---------------|
| 08/10/2020 | | Page 14 of 23 |
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ACTIEON
## X-MIND prime 3D
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Via Roma, 45 21057 Olgiate Olona (VA)
| | Proposed device:<br>X-MIND prime 3D | Primary predicate device:<br>X-MIND prime 3D<br>(Rotograph Prime 3D) |
|-----------------------------------------------------|---------------------------------------------------------|----------------------------------------------------------------------|
| 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 |
| 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<br>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,<br>chin support, head strip | Temple clamps, bite block, chin<br>support, head strip |
| 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 | Face to face | Face to face |
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
|------------|------------------------------------|---------------|
| 08/10/2020 | | Page 15 of 23 |
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ACTIEON
## X-MIND prime 3D
VOL. 004
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Via Roma, 45 21057 Olgiate Olona (VA)
| | Proposed device:<br>X-MIND prime 3D | Primary predicate device:<br>X-MIND prime 3D<br>(Rotograph Prime 3D) |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Height of chin support from the<br>floor | 978-1678 mm | 975-1635 mm |
| User interface | | |
| Real time visualization | Yes | Yes |
| PC connection | Two dedicated Giga-Ethernet<br>channels: one for the machine<br>communication and for the<br>ceph detector, the second<br>dedicated to the PAN/3D<br>detector | Ethernet for the machine<br>communication + point to point<br>dedicated giga-ethernet for the<br>detector |
| User interface | Onboard keyboard and virtual<br>control panel (on PC) | Onboard keyboard and virtual<br>control panel (on PC) |
| 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. |
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
|------------|------------------------------------|---------------|
| 08/10/2020 | | Page 16 of 23 |
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ACTIEON
# X-MIND prime 3D
VOL. 004
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Via Roma, 45 21057 Olgiate Olona (VA)
| | Proposed device:<br>X-MIND prime 3D | Primary predicate device:<br>X-MIND prime 3D<br>(Rotograph Prime 3D) |
|------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Firmware functions<br>(of Control Processing Units) for<br>controlling movements and<br>image<br>acquisition/synchronization | Firmware functions are<br>designed to manage the<br>panoramic/3D version and<br>the cephalometric option.<br>Some differences in the<br>firmware functions are<br>related to the management of<br>the added cephalometric<br>option. Some additional<br>differences are related to<br>specific hardware solutions or<br>different microprocessors<br>from the Primary Predicate<br>Device. | Firmware functions are<br>designed to manage the<br>following configuration:<br>panoramic/3D version |
| X-ray generator board firmware<br>functions | X-ray parameters (kV, mA,<br>pulsed / continuous emission)<br>management, X-ray start and<br>stop, errors control.<br>Can Bus communication. | X-ray parameters (kV, mA,<br>pulsed / continuous emission)<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;<br>image reconstruction |
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
|------------|------------------------------------|---------------|
| 08/10/2020 | | Page 17 of 23 |
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# X-MIND prime 3D
VOL. 004
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Via Roma, 45 21057 Olgiate Olona (VA)
| | Proposed device:<br>X-MIND prime 3D | Primary predicate device:<br>X-MIND prime 3D<br>(Rotograph Prime 3D) |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image acquisition | Integration of the specific<br>detector manufacturer SDK;<br>PC memory and disk space<br>management and control. | Integration of the specific<br>detector manufacturer SDK; PC<br>memory and disk space<br>management and control. |
| Image correction (defect map,<br>offset and flat field) | Correction functions for<br>detector are designed by<br>Acteon / Owandy. Offset<br>correction is done before<br>each acquisition | Correction functions for<br>detector are designed by<br>Acteon / Owandy. Offset<br>correction is done before<br>each acquisition |
| 2D examination programs' final<br>image | The frames acquired by the<br>Flat panel detector in area<br>mode after the corrections,<br>are elaborated with a shift<br>and add procedure to form<br>the final image. This<br>procedure applies to<br>cephalometric images too | The frames acquired by the Flat<br>panel detector in area mode are<br>after the correction, are<br>elaborated with a shift and add<br>procedure to form the final<br>image |
| 2D examination programs'<br>image pre-processing | GUI provides basic image pre-<br>processing capabilities that<br>the user can enable or<br>disable. By default they are<br>disabled. This procedure<br>applies to cephalometric<br>images too | GUI provides basic image pre-<br>processing capabilities that the<br>user can enable or disable. By<br>default they are disabled. |
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
|------------|------------------------------------|---------------|
| 08/10/2020 | | Page 18 of 23 |
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Via Roma, 45 21057 Olgiate Olona (VA) 510(k) Summary
| | Proposed device:<br>X-MIND prime 3D | Primary predicate device:<br>X-MIND prime 3D<br>(Rotograph Prime 3D) |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 3D examination image<br>reconstruction | The frames acquired by the<br>Flat panel detector in area<br>mode after the correction, are<br>elaborated with a Feldkamp<br>algorithm -and eventually<br>with the MAR algorithm- to<br>get a set of axial slices; then a<br>dicom header is added to<br>each slice file. Dicom dataset<br>is then saved to disk for<br>transfer to external<br>visualization/processing<br>programs.<br>The 3D reconstruction is done<br>using PC GPU or CPU. | The frames acquired by the Flat<br>panel detector in area mode<br>after the correction, are<br>elaborated with a Feldkamp<br>algorithm -and eventually with<br>the MAR algorithm- to get a set<br>of axial slices; then a dicom<br>header is added to each slice<br>file. Dicom dataset is then<br>saved to disk for transfer to<br>external<br>visualization/processing<br>programs.<br>The 3D reconstruction is done<br>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.
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
|------------|------------------------------------|---------------|
| 08/10/2020 | | Page 19 of 23 |
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| . | 1 | . . | |
|---|---|-----|--|
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510(k) Summary
Via Roma, 45 21057 Olgiate Olona (VA)
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:<br>X-MIND prime 3D | Additional predicate device:<br>DENTIOIII series (DENTIOIII,<br>DENTIOIII-S) |
|----------------------------------------|-----------------------------------------------------------------|------------------------------------------------------------------------------|
| Cephalometric imaging<br>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 $\mu$ 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<br>programs | | |
| Exam time | Max 15.1 s (HD) / min 4.4 s<br>(HS) | Max 8.2 s (Normal) / 4.2 s (Fast) |
| Frontal (AP/PA) projection | Yes | Yes |
| Lateral (LL) projection | Yes | Yes |
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
|------------|------------------------------------|---------------|
| 08/10/2020 | | Page 20 of 23 |
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Via Roma, 45
### X-MIND prime 3D
VOL. 004
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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:
| Rev. n. 2 | | VOL. 004 |
|------------|------------------------------------|---------------|
| 08/10/2020 | X-MIND prime 3D 510(k) Abbreviated | Page 21 of 23 |
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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.
VOL. 004
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Via Roma, 45 21057 Olgiate Olona (VA) 510(k) Summary
| Applied standards | Proposed device:<br>X-MIND prime 3D | Primary predicate device:<br>X-MIND prime 3D<br>(Rotograph Prime 3D) |
|-------------------|--------------------------------------------------------|----------------------------------------------------------------------|
| | IEC 60601-1: 2005 + CORR. 1<br>(2006) + CORR. 2 (2007) | IEC 60601-1: 2005 + CORR. 1<br>(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<br>A1:2012 | ANSI/AAMI ES60601-1: 2005 /<br>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.
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
|------------|------------------------------------|---------------|
| 08/10/2020 | | Page 22 of 23 |
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