Who is the manufacturer of X-MIND Trium?

De Gotzen S.R.L. filed the 510(k) submission for X-MIND Trium (K191719).

What is the FDA product code for X-MIND Trium?

MUH. It is classified under 21 CFR 872.1800 as a Class 2 device in the Dental panel.

What is the regulatory pathway for X-MIND Trium?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like X-MIND Trium?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

X-MIND Trium

K191719 · De Gotzen S.R.L. · MUH · Feb 20, 2020 · Dental

Device Facts

Record ID	K191719
Device Name	X-MIND Trium
Applicant	De Gotzen S.R.L.
Product Code	MUH · Dental
Decision Date	Feb 20, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.1800
Device Class	Class 2
Attributes	Pediatric

Intended Use

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

Device Story

X-MIND Trium is a digital extra-oral X-ray system for panoramic, cephalometric, and CBCT imaging. It uses an X-ray generator and flat-panel CMOS detector to capture images of the maxillofacial region. The system features a rotating U-arm and adjustable Source-to-Image Distance (SID). The TLD (True Low Dose) configuration uses a single sensor for both PAN and CBCT, allowing for reduced SID and dose-saving protocols. Operated by clinicians via a workstation running AIS software, the device provides 2D/3D visualization and post-processing tools. The system is used in dental and maxillofacial clinics for diagnostics, surgery, and implant planning. Output images assist clinicians in anatomical assessment and treatment planning, potentially reducing radiation exposure through optimized low-dose protocols.

Clinical Evidence

Bench testing only. Performance evaluated via image quality (CNR, voxel noise, NPS) and radiation dose (DAP) comparisons between standard and low-dose protocols. A detectability study involving radiologists, dentists, and oral surgeons confirmed that pathological/clinically relevant conditions identifiable in standard protocols were also identified in low-dose protocols. No clinical prospective/retrospective studies were required.

Technological Characteristics

Digital extra-oral X-ray system; CMOS flat-panel detector; Tungsten anode X-ray tube (0.5 mm focal spot); 60-90 kV range; 4-10 mA current. Connectivity via Ethernet to workstation. Software includes AIS 2D/3D modules. Complies with IEC 60601-1, IEC 60601-2-63, and 21 CFR 1020.30/31/33.

Indications for Use

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

Regulatory Classification

Identification

An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

Predicate Devices

X-MIND trium (K160166)

Related Devices

K160166 — X-MIND trium · De Gotzen S.R.L. · Nov 15, 2016
K201382 — X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) · De Gotzen S.R.L. · Nov 18, 2020
K214084 — hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS · Cefla S.C. · Jan 20, 2022
K223794 — hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS · Cefla S.C. · Jan 17, 2023
K160525 — RCT700 · Ray Co., Ltd. · Jun 20, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ February 20, 2020 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in two lines. de Götzen S.r.l % Dario Bandiera Quality Manager via Roma, 45 21057 Olgiate Olona, Varese ITALY Re: K191719 Trade/Device Name: X-MIND Trium Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS, MUH Dated: January 10, 2020 Received: January 22, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ 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 mediation-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) K191719 Device Name X-MIND trium #### Indications for Use (Describe) Indications for Use (Describe) X-MIND trium is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, indicated for use in: - producing panoramic X-ray images for diagnostic examination (teeth), jaws and oral structures; - producing radiographs of maxillofacial region and parts of the skull for cephalometric examination, if equipped with - CEPH arm; - producing radiographs of hands and wrists for carpus examination, if equipped with CEPH arm; - producing tomographic images of the oral and maxillofacial region, for diagnostic examination of dentition (teeth), jaws, oral structures and some cranial bones, if equipped with CBCT option. From a clinical point of view, X-MIND trium can be applied for the following medical indications: - · Generic dentistry - · Dental implantology - · Dental surgery - Maxillo-facial surgery - · Cephalometric analysis - · Carpus radiology The target patient population includes adults and pediatric patients from 5 years old [~21 kg (46 lb); 113 cm (44.5 in) standing height]; anyway the sustainability to X-ray exposure must be evaluated by surgeons, dentists 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) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ | ACTEON Via Roma, 45 21057 Olgiate Olona (VA) | X-MIND trium 510(k) Summary | VOL. 005 002_k Summary | |----------------------------------------------------|--------------------------------|---------------------------| | | | K191719 | #### Index | | 510 (k) Summary | 2 | |-------|-----------------------------------------------------------------------|----| | I. | SUBMITTER | 2 | | II. | DEVICE | 2 | | III. | PREDICATE DEVICE | 3 | | IV. | DEVICE OVERVIEW | 3 | | V. | MAIN CHANGES TO THE PREVIOUS CLEARED DEVICE ARE | 4 | | VI. | OVERVIEW OF THE SYSTEM | 8 | | VII. | OVERVIEW OF THE SCANNER | 10 | | VIII. | EQUIPMENT CONFIGURATIONS | 13 | | IX. | EXAMS | 15 | | X. | Setup configuration | 15 | | | Wall mounted | 15 | | | Self-standing | 17 | | XI. | ACCESSORIES | 18 | | XIII. | COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE | 21 | | XIV. | PERFORMANCE, SAFETY, EMC TESTS | 55 | | XV. | CONCLUSIONS | 57 | | Rev. n. 2 | | VOL. 005 | |------------|----------------------|--------------| | 10/01/2020 | X-MIND trium 510 (k) | Page 1 of 58 | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for ACTEON. The logo consists of the word "ACTEON" in bold, sans-serif font. A blue swoosh appears to the left of the word, adding a dynamic element to the design. The overall impression is modern and professional. Via Roma, 45 #### X-MIND trium VOL. 005 K191719 #### 510 (k) Summary 21057 Olgiate Olona (VA) The summary of this 510(k) is being submitted in accordance with the requirements of 21 CFR Part 807.92. #### l. 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 | | Dario Bandiera | dario.bandiera@acteongroup.com | | Alvise Reither | alvise.reither@acteongroup.com | | Date: | 10/01/2020 | #### Table 1: Submitter information #### II. DEVICE | Name of the device: | X-MIND trium | |-----------------------|-------------------------------------------------------| | 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, MUH | Table 2: device | Rev. n. 2 | X-MIND trium 510 (k) | VOL. 005 | |------------|----------------------|--------------| | 10/01/2020 | | Page 2 of 58 | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Acteon. The logo consists of the word "ACTEON" in a bold, sans-serif font. A blue swoosh design is located to the left of the word. The swoosh starts thin and curves upward, becoming thicker as it moves towards the letter "A". VOL. 005 Summary 002_k Summary Via Roma, 45 21057 Olgiate Olona (VA) 510(k) Summary #### III. PREDICATE DEVICE Legally marketed device to which equivalence is claimed is: | PREDICATE DEVICE | | |-------------------------|----------------------------------| | Device name | X-MIND trium | | Manufacturer | de Götzen S.r.l. - ACTEON Group | | Device product code | OAS | | Subsequent product code | MUH | | Regulation number | 892.1750 | | Regulation name | Computed tomography x-ray system | | Clearance date | November 15, 2016 | | 510(k) number | K160166 | Table 3: Predicate device information This predicate has not been subjected to a design-related recall. No reference devices were used in this submission. #### IV. DEVICE OVERVIEW The modified X-MIND trium has the same indication for use of X-MIND trium (as identified in the labelling) and it is based on the same fundamental scientific technology. It is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, indicated for use in: - producing panoramic X-ray images for diagnostic examination of dentition (teeth), jaws and oral structures; - producing radiographs of maxillofacial reqion and parts of the skull for cephalometric examination, if equipped with CEPH arm; - producing radiographs of hands and wrists for carpus examination, if equipped with CEPH arm; - producing tomographic images of the oral and maxillofacial region, for diagnostic examination of dentition (teeth), jaws, oral structures and some cranial bones, if equipped with CBCT option. From a clinical point of view, X-MIND trium can be applied for the following medical indications: • Generic dentistry • Dental implantology | Rev. n. 2 10/01/2020 | X-MIND trium 510 (k) | VOL. 005 Page 3 of 58 | |-------------------------|----------------------|--------------------------| |-------------------------|----------------------|--------------------------| {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for ACTEON. The logo features the company name in bold, sans-serif font, with the letters slightly slanted to the right. A curved, blue graphic element is positioned to the left of the word "ACTEON", adding a visual accent to the logo. VOL. 005 - · Dental surgery Via Roma, 45 - Maxillo-facial surgery - Cephalometric analysis - · Carpus radiology The target patient population includes adults and pediatric patients from 5 years old [~21 kg (46 lb); 113 cm (44.5 in) standing height]; anyway, the sustainability to X-ray exposure must be evaluated by surgeons, dentists and qualified and authorized physicians. #### V. MAIN CHANGES TO THE PREVIOUS CLEARED DEVICE ARE Main changes to the previous cleared device are addition of a new accessory: new sliding cassette called X-MIND trium TLD cassette including a new model of CBCT sensor (C12903D-40 - Hamamatsu) that can be used for both panoramic and CBCT examination; introduction, as alternative components, of CEPH and PAN sensors with wider admitted range of power supply value: (from 4.9 – 5.1 VDC to 8 – 12 VDC). Since CBCT and PAN sensor usually operates on a different SID (Source to Image Distance), a new movement of the cassette has been added, to give to the device the possibility to modify the SID. The possibility to configure the SID allows also the possibility to perform special exam for child: reduced SID distance that means possible reduction of x-ray dose to the patient. Image /page/6/Figure/15 description: The image shows a diagram of the X-MIND trium rotating arm with different sliding cassette configurations. The top row shows the original sliding cassette being cleared from the X-MIND trium rotating arm. The bottom row shows a new TLD sliding cassette being added to the X-MIND trium rotating arm. The diagram illustrates the process of upgrading or modifying the X-MIND trium rotating arm with different sliding cassette options. Figure 1 addition of TLD Sliding cassette The lateral movement of the cassette is obtained with the same motor used in the cleared version of X-MIND trium. For the movement we use a new linear quide with ball bearing runners. | Rev. n. 2 | X-MIND trium 510 (k) | VOL. 005 | |------------|----------------------|--------------| | 10/01/2020 | | Page 4 of 58 | {7}------------------------------------------------ | | X-MIND trium | VOL. 005 | |--------------------------|----------------|---------------| | | | 002_k Summary | | Via Roma, 45 | 510(k) Summary | | | 21057 Olgiate Olona (VA) | | | The SID movements uses the same motor as the one installed in the handle rest area of the patient (satellite group), and two linear guides with ball bearing runners as the cleared version of TRIUM The cassette is made of a steel plate with the new CBCT sensor and relevant shielding lead on the back. Image /page/7/Picture/3 description: The image shows a close-up of a mechanical device with various components. There is a large square orange component with the numbers 121.2 and 140 on it. The device also has green, purple, and tan components, as well as several screws and bolts. The device appears to be a part of a larger machine or system. Figure 2: new TLD cassette scheme The new CBCT sensor has nominal dimensions of 15x12 cm, while the sensor used in cleared version of X-MIND trium is 12x12. The 15 cm height is required to allow panoramic examinations. The new sensor C12903D-40 has 8V power supply input while the previous was 5V. Similarly, the new SID movements require a related driver. For that reason, a new AUXCBCT board has been designed with code: PE5541_AUXCBCTPLUS. The overall insulation diagram of the whole device has not changed in respect of the cleared X-MIND trium, apart from the absence of the contacts for PAN and CEPH sensors that aren't anymore detachable (improvement) The relevant insulation of the board PE5541 AUXCBCTPLUS A01 is the same as the PE4016_AUXCBCT_A04, already installed (and certified) on the V1 version of the TRIUM. Due to the possibility to reduce the SID, special exams for child has been introduced and at the same time we have developed countermeasures to avoid that an adult is positioned during a special child exam. The new workflow on the software introduces a new step: the doctor uses a tool provided with the machine to check if the user fits the proper dimension for the examination with the reduced SID. | Rev. n. 2 | | VOL. 005 | |------------|----------------------|--------------| | 10/01/2020 | X-MIND trium 510 (k) | Page 5 of 58 | {8}------------------------------------------------ | | <img alt="ACTEON Logo" src="..."/> | X-MIND trium | VOL. 005 | |--------------------------|------------------------------------|---------------|----------| | Via Roma, 45 | 510(k) Summary | 002_k Summary | | | 21057 Olgiate Olona (VA) | | | | Figure 3: use of head measurement tool DON'T FIT X-MIND trium and the X-MIND trium TLD are provided with a new functionality, the Low Dose functionality. The Low Dose functionality allows the user to perform the CBCT exams by using the Low Dose protocols for all kind of patients (MAN, WOMAN and CHILD) as an alternative of the Standard Dose protocols. FIT The selection of a Low Dose protocol is performed in the AIS interface during the specification of the exam settings (see Figure 4). A Low Dose protocol applies at least the half of the anodic current than the corresponding Standard Dose protocol, so ensuring a radiation dose saving for the patient of about 50% (refer to the declared DAP in the AIS interface, Figure 5); the image quality by the Low Dose protocols ensures the same diagnostic value as the corresponding Standard Dose protocols (Basing on the bench test results on image quality and radiation dose obtained). | Rev. n. 2 | X-MIND trium 510 (k) | VOL. 005 | |------------|----------------------|--------------| | 10/01/2020 | | Page 6 of 58 | {9}------------------------------------------------ | ACTEON Via Roma, 45 21057 Olgiate Olona (VA) | X-MIND trium 510(k) Summary | VOL. 005 002_k Summary | |----------------------------------------------------|--------------------------------|---------------------------| |----------------------------------------------------|--------------------------------|---------------------------| Image /page/9/Picture/1 description: The image shows a graphical user interface (GUI) with various options and settings, likely for a medical imaging device. The GUI includes options for selecting patient size (Man, Woman, Child, Small, Medium, Large), field of view (Dental FOV, ENT FOV - Nose, ENT FOV - Ear), image size (40x40, 60x60, 80x80, 110x90), and image quality (Standard, Medium, High). There are also options for dose (Standard dose, Low dose) and additional settings such as Show Warnings, Select Filters, Select Focus Point, Scout, and Fill Dental Chart, all of which appear to be toggled 'ON'. Figure 4 - AIS interface for the definition of the Low Dose protocol | | Standard | Low Dose | |----------------------------|----------|----------| | Current (mA) | 8 | 4 | | Voltage (kV) | 90 | 45 | | Current Time Product (mAs) | 55.9 | 27.9 | | DAP (mGycm²) | 902.7 | 451.35 | Figure 5 - Acquisition parameters and dose declaration between Standard Dose and Low Dose protocols | Rev. n. 2 | X-MIND trium 510 (k) | VOL. 005 | |------------|----------------------|--------------| | 10/01/2020 | | Page 7 of 58 | {10}------------------------------------------------ | ACTEON | VOL. 005 | |--------------------------|---------------| | Via Roma, 45 | 002_k Summary | | 21057 Olgiate Olona (VA) | | | | | | X-MIND trium | | | 510(k) Summary | | #### VI. OVERVIEW OF THE SYSTEM Image /page/10/Figure/2 description: The image shows a diagram of a dental X-ray machine and its connections to other devices. The diagram includes a computer labeled as '1', a radiation warning device labeled as '2', and a power supply labeled as '3'. The dental X-ray machine is labeled as '4' and is connected to all three devices via lines. The diagram illustrates the setup and connections required for the dental X-ray machine to function properly. Figure 6: overview of the system | Part 1 | - 1 Gb, 8-wire Ethernet cable cat. 6>250mhz, 27 AWG, 10 m long - Operator's Workstation | |----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Part 2 Image: Radioactivity symbol and remote control | - Control cable, 10 wires, 5 twisted pairs 10 m long aluminium shielded - X-MIND trium Remote Control - X-MIND trium Light | | Part 3 Image: Terminal block | - Power cord, 3G1,5 AWG 16, 300 / 500 V, 10 m long -Connection to the mains by means of clamps and screws (Equipment installed permanently in compliance with IEC 60601- 1) | | Rev. n. 2 | X-MIND trium 510 (k) | VOL. 005 | |------------|----------------------|--------------| | 10/01/2020 | | Page 8 of 58 | {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for ACTEON. The logo is in black font and has a blue swoosh underneath it. The logo is simple and modern. VOL. 005 002_k Summary #### 510(k) Summary Via Roma, 45 21057 Olgiate Olona (VA) Image /page/11/Picture/5 description: The image is split into two parts. The left side of the image contains the text "Part 4". The right side of the image shows a close-up of electrical components, including wires and connectors. The components are various colors, including white, black, yellow, and blue. - X-MIND trium main connector consisting of 3 modules Communication, control and power supply - Moving part of the X-MIND trium connector - Fixed part of the X-MIND trium connector Table 4: details of the system The system consists of: - . X-MIND trium SCANNER - . OPERATOR'S WORKSTATION The operator can control all aspects of the medical device by means of the workstation that can be supplied by de Götzen. The workstation must have installed with the following modules: - . AIS equipment management software + AIS 2DApp diagnostic analysis - . AIS 3DApp dataset display software CBCT Communication with the medical device occurs by means of a sturdy and reliable Ethernet protocol. The workstation allows the operator to perform the following procedures: - Calibrations of the medical device - - Acquisition parameters setting - - -Getting an acquisition - Image visualization and post processing - - -Database management - Periodic quality Tests - - X-MIND trium REMOTE CONTROL . The X-MIND trium remote control must be in a safe place protected against radiations, in compliance with the local standards in force concerning ionising radiation protection. The X-MIND trium remote control allows the operator to activate or deactivate X-ray emission from the control room. This consists of two switches, one for exposure and one for emergency, which control device operation. - . X-MIND trium Light | Rev. n. 2 | X-MIND trium 510 (k) | VOL. 005 | |------------|----------------------|--------------| | 10/01/2020 | | Page 9 of 58 | {12}------------------------------------------------ | | X-MIND trium | VOL. 005 | |--------------------------|----------------|---------------| | ACTEON | | 002_k Summary | | Via Roma, 45 | 510(k) Summary | | | 21057 Olgiate Olona (VA) | | | The X-MIND trium Light is an indicator light that warns that X-ray emission is in progress. #### VII. OVERVIEW OF THE SCANNER Image /page/12/Figure/3 description: The image shows a dental X-ray machine with several parts labeled with numbers. The numbers range from 1 to 10, each pointing to a specific component of the machine. The image also includes a close-up view of a section of the machine, with parts labeled 5, 6, and 7. Figure 7: overview of the scanner | Rev. n. 2 | X-MIND trium 510 (k) | VOL. 005 | |------------|----------------------|---------------| | 10/01/2020 | | Page 10 of 58 | {13}------------------------------------------------ VOL. 005 002_k Summary Via Roma, 45 21057 Olgiate Olona (VA) 510(k) Summary The X-MIND trium scanner consists of the following parts: | 1 | Control panel | The control panel provides an intuitive overview of the system to move the mobile column, turn the positioning lasers on and off and activate the X-MIND trium medical device. | |---|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 2 | X-ray generator | The X-ray assembly is the source of the X-ray beam during the rotation of the U-Arm. The pulsed beam is modelled by an automatic collimator, whereas the electronic control ensures stability and accuracy of the selected loading factors (exposure time, kVp and anodic current). An aluminium filter is used to harden the beam and remove low-energy ionising radiations, thereby obtaining suitable radiation quality whilst reducing its dose absorbed by the patient. | | 3 | Sliding body | The sliding body is the mobile part of the column that supports U- arm. | | 4 | U-arm | The U-Arm supports the Detector sliding group and the X-ray generator. This is the rotating part of the medical device, which moves around the patient during the image acquisition phase. | | 5 | Detector sliding group | It contains detectors that allow acquire images. This cassette can be provided in the following versions: PAN Only cassette; Standard PAN/ CBCT Cassette; TRUE LOW DOSE cassette that permit to perform both PAN and CBCT exams. (* only with X-MIND trium TLD version) | | 6 | CBCT detector | This flat panel detector is indicated for use in generating radiographic images of the maxillo-facial region, more specifically it is dedicated for CBCT acquisitions. in X-MIND trium TLD version there is only one image detector, for PAN and CBCT exam; the equipment automatically exposes in front of X-Ray source the right portion of detector, depending on the selected exam; | | 7 | PAN detector | This flat panel detector is indicated for use in generating radiographic images of the maxillo-facial region, more specifically it is dedicated for PAN acquisitions. | | Rev. n. 2 | X-MIND trium 510 (k) | VOL. 005 | |------------|----------------------|---------------| | 10/01/2020 | | Page 11 of 58 | {14}------------------------------------------------ | Image: ACTEON logo | X-MIND trium 510(k) Summary | VOL. 005 002_k Summary | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Via Roma, 45 21057 Olgiate Olona (VA) | | | | | * in X-MIND trium TLD version there is only one image detector, for PAN and CBCT exam; the equipment automatically exposes in front of X-Ray source the right portion of detector, depending on the selected exam; | | | 7 | TLD CASSETTE* | * only for X-MIND trium TLD version Sliding cassette that lets to activate true low dose exams. Some models of X-MIND trium can be upgraded in the field to TLD cassette configuration. | | 8 | Patient support | The patient support allows stabilising and immobilising the patient. It is equipped with instruments to move the patient's head in all directions and find the best superimposition between the patient's anatomy and the Field of View (FOV). | | 9 | F group | It is the whole assembled mobile group of the device. It is the moving part of the medical device, which adapts the acquisition geometry to the patient's anatomy and stance (sitting or standing). It supports the U-Arm and head support. | | 10 | Column | The fixed column supports the entire structure of the medical device. This contains the motor that raises and lowers the mobile column, the main control panel of the system and the main switch. In the wall installation version, the fixed column is equipped with an anchor plate; in the free-standing version, on the other hand, the medical device is equipped with a footrest. CEPH arm extension (not represented in Overview of the medical device) | The ceph arm extension can be positioned both on the right or left side of the vertical column, with the patient positioning aiming device (ear and nasion rest) for CEPH exams; | Rev. n. 2 | X-MIND trium 510 (k) | VOL. 005 | |------------|----------------------|---------------| | 10/01/2020 | | Page 12 of 58 | {15}------------------------------------------------ VOL. 005 Via Roma, 45 21057 Olgiate Olona (VA) 510(k) Summary 002_k Summary the CEPH secondary collimator, translating during X Rays (to stay aligned with the X-Ray beam emerging from the tubehead on overhead carriage); the CEPH image detector, translating during X Rays (to stay aligned with the X-Ray beam emerging from the secondary collimator on the CEPH arm itself) #### VIII. EQUIPMENT CONFIGURATIONS X-MIND trium equipment can be sold in these different configurations: #### PAN only the equipment can carry out uniquely exams of the PAN group (PAN, TMJ, Sinus); the image detector is not movable from PAN bay; all the exams are carried out with the same extension in height on image receptor), primary collimator beinq of fixed dimension; the equipment can be upgraded in the field to more advanced configurations #### PAN / CBCT the equipment can carry out uniquely exams of the PAN group (PAN, TMJ, Sinus) and of the CBCT group; there are two image detectors, one for PAN and one for CBCT exam; the equipment automatically exposes in front of X-Ray source the right detector, depending on the selected exam; the PAN exams can be carried out with different extension in height (up to 146mm height on imaqe receptor), primary collimator being automatically adjusted in height, dependinq on exam selected by the user: the CBCT exams can be carried out at different FOV dimensions; the equipment can be upgraded in the field to PAN/CEPH/CBCT configuration by simple procedure, adding CEPH arm with CEPH image detector replacing the existing PAN image detector; the equipment has a touch screen panel as main user interface; #### PAN / CEPH the equipment can carry out uniquely exams of the PAN group (PAN, TMJ, Sinus) and of the CEPH group (AP/PA, LL, carpus); the image detector is unique, both for PAN and CEPH exams, and must be manually moved from PAN bay to CEPH bay and viceversa, depending on the selected exam; the exams can be carried out with different extension in height (up to 146mm height on image receptor for PAN, up to 220mm height on image receptor for CEPH), primary collimator being automatically adjusted in height depending on exam selected by the user; | Rev. n. 2 | X-MIND trium 510 (k) | VOL. 005 | |------------|----------------------|---------------| | 10/01/2020 | | Page 13 of 58 | {16}------------------------------------------------ | X-MIND trium | |--------------| |--------------| VOL. 005 002_k Summary Via Roma, 45 21057 Olgiate Olona (VA) the equipment can be upgraded in the field to PAN/CBCT/CEPH configuration by simple procedure, adding CBCT image detector and bite block holder with vertical movement; the equipment mounts PAN detector sliding unity. #### PAN / CBCT / CEPH (PAN Full) the equipment can carry out all feasible exams of the PAN group (PAN, TMI, Sinus), of the CEPH group (AP/PA, LL, carpus) and of the CBCT group; there are two image detectors, one for PAN/CEPH and one for CBCT exam; to carry out PAN or CEPH exam the PAN/CEPH image detector must be manually moved from PAN bay to CEPH bay and viceversa; to carry out PAN or CBCT exam the equipment automatically exposes in front of X-Ray source the right detector, depending on the selected exam; the PAN and CEPH exams can be carried out with different extension in height (up to 146mm height on image receptor for PAN, up to 220mm height on image receptor for CEPH), primary collimator being automatically adjusted in height depending on exam selected by the user; the CBCT exams can be carried at different FOV dimensions; the equipment has a touch screen panel as main user interface; #### PAN / CBCT TLD version The equipment can carry out both exams of the PAN group (PAN, TMJ, Sinus) and of the CBCT group; There is only one image detector, for PAN and CBCT exam; the equipment automatically exposes in front of X-Ray source the right portion of detector, depending on the selected exam; PAN exams can be carried out with different extension in height (up to 146 mm height on image receptor), since the collimator height can be adjusted depending on the exam selected by the user; CBCT exams can be carried out at different FOV dimensions; The equipment can be upgraded in the field to CEPH configuration by simple procedure, adding CEPH arm with CEPH image detector. #### PAN / CBCT / CEPH TLD version The equipment can carry out all feasible exams of the PAN group (PAN, TMJ, Sinus), of the CEPH group (AP/PA, LL, carpus) and of the CBCT group; To carry out PAN or CEPH or CBCT exam the equipment automatically exposes in front of X-Ray source the right detector, depending on the selected exam; PAN and CEPH exams can be carried out with different extension in height (up to 146 mm height on image receptor for PAN, up to 220 mm height on image receptor for CEPH), since the primary collimator can be automatically adjusted in height depending on exam selected by the user; the image detector is not movable from CEPH bay; | Rev. n. 2 10/01/2020 | X-MIND trium 510 (k) | VOL. 005 Page 14 of 58 | |-------------------------|----------------------|---------------------------| |-------------------------|----------------------|---------------------------| {17}------------------------------------------------ | Via Roma, 45 | |--------------------------| | 21057 Olgiate Olona (VA) | VOL. 005 #### IX. EXAMS In its different configurations X-MIND trium equipment carries out the following exams (also said projections): #### PAN group - Standard panorama - - Child special SID panorama (only with TLD cassette) - - TMJ . - Bitewing - - Sectorial - - Maxillary sinuses - #### CBCT type - Full view - - Extended view (TBC) । - Stitched (TBC) - - Child special SID CBCT (only with TLD cassette) - #### CEPHALOGRAPHIC type - Frontal - - Lateral - - Child lateral (reduced height and width) (non c'è nel manuale) o - Complete lateral (non c'è nel manuale) O - -Hand acquisition (special support needed) #### Setup configuration X. #### Wall mounted For this type of installation, the column is provided with two dedicated plates to fasten the equipment to the wall. | Rev. n. 2 | | VOL. 005 | |------------|----------------------|---------------| | 10/01/2020 | X-MIND trium 510 (k) | Page 15 of 58 | {18}------------------------------------------------ | ACTEON Via Roma, 45 21057 Olgiate Olona (VA) | X-MIND trium 510(k) Summary | VOL. 005 002_k Summary | |----------------------------------------------------|--------------------------------|---------------------------| |----------------------------------------------------|--------------------------------|---------------------------| | Rev. n. 2 | X-MIND trium 510 (k) | VOL. 005 | |------------|----------------------|---------------| | 10/01/2020 | | Page 16 of 58 | {19}------------------------------------------------ ![ACTEON Logo](image.png) | Via Roma, 45 | |--------------| |--------------| VOL. 005 #### Self-standing The self-standing accessory allows to install X-MIND trium without structurally fix it to the wall; the self-standing alone is designed to give full structural support to X-MIND trium for installation where the walls do not guarantee such support. Although self-standing is sufficient to provide alone the needed structural support to X-MIND trium, it is anyway highly recommended to fix the X-MIND trium also to the wall, to reduce as much as possible the vibrations during the exams; this wall fixation has not safety implications, so it is responsibility of the customer to use it or not. Image /page/19/Picture/9 description: The image shows a gray metal plate with a red rectangular inset. The plate has a Y-shape on both ends, with holes at the end of each arm of the Y. The red inset has several smaller holes and a rectangular cutout in the center. Figure 9: wall mounted base | Rev. n. 2 | X-MIND trium 510 (k) | VOL. 005 | |------------|----------------------|---------------| | 10/01/2020 | | Page 17 of 58 | {20}------------------------------------------------ 21057 Olgiate Olona (VA) ### X-MIND trium VOL. 005 510(k) Summary 002_k Summary 510(k) Summi #### XI. ACCESSORIES Via Roma, 45 | XMT SELF STANDING BASE (FWT) | Image: XMT SELF STANDING BASE (FWT) | |------------------------------|-------------------------------------| | XMT REMOTE BUTTON | Image: XMT REMOTE BUTTON | | EXTERNAL LIGHT 100 - 240 V | Image: EXTERNAL LIGHT 100 - 240 V | | XMT CARPUS SUPPORT | Image: XMT CARPUS SUPPORT | | XMt UPG CEPH | Image: XMt UPG CEPH | | XMt UPG 3D | Image: XMt UPG 3D | | XMt TRUE LOW DOSE CASSETTE | Image: XMt TRUE LOW DOSE CASSETTE | Table 6: accessories | Rev. n. 2 | X-MIND trium 510 (k) | VOL. 005 | |------------|----------------------|---------------| | 10/01/2020 | | Page 18 of 58 | {21}------------------------------------------------ | ACTEON | |--------------------------| | Via Roma, 45 | | 21057 Olgiate Olona (VA) | | X-MIND trium | VOL. 005 | |----------------|---------------| | 510(k) Summary | 002_k Summary | #### XII. CONFIGURATIONS Image /page/21/Picture/2 description: The image shows four different X-MIND trium Pan dental imaging systems and their features. The first system, "X-MIND trium Pan", has the "Pan" feature. The second system, "X-MIND trium Pan 3D", has both the "Pan" and "3D" features. The third system, "X-MIND trium Pan Ceph", has the "Pan" and "Ceph" features, and the fourth system, "X-MIND trium Pan Ceph 3D", has the "Pan", "3D", and "Ceph" features. O`upgadable on site | Rev. n. 2 10/01/2020 | X-MIND trium 510 (k) | VOL. 005 Page 19 of 58 | |-------------------------|----------------------|---------------------------| |-------------------------|----------------------|---------------------------| {22}------------------------------------------------ | Via Roma, 45 21057 Olgiate Olona (VA) | X-MIND trium 510(k) Summary | VOL. 005 002_k Summary | |----------------------------------------------|--------------------------------|---------------------------| |----------------------------------------------|--------------------------------|---------------------------| - Image /page/22/Picture/1 description: The image shows two dental X-ray machines, labeled "X-MIND trium TLD Pan 3D" and "X-MIND trium TLD Pan Ceph 3D". A table below the machines indicates the availability of different scan types for each machine. The "X-MIND trium TLD Pan 3D" machine offers Pan and 3D scans, while the "X-MIND trium TLD Pan Ceph 3D" machine offers Pan, 3D, and Ceph scans. | Rev. n. 2 | X-MIND trium 510 (k) | VOL. 005 | |------------|----------------------|---------------| | 10/01/2020 | | Page 20 of 58 | {23}------------------------------------------------ Image /page/23/Picture/0 description: The image shows the Acteon logo with a blue swoosh underneath the letters. Below the logo is the text "Via Roma, 45". The text is in a simple, sans-serif font and is left-aligned. VOL. 005 002_k Summary Via Roma, 45 21057 Olgiate Olona (VA) 510(k) Summary #### XIII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE | Characteristic | Predicate | Proposed | Change Id | |--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | | X-MIND trium | X-MIND trium | | | Manufacturer | de Götzen S.r.l. – Acteon Group | de Götzen S.r.l. – Acteon Group | same | | | Via Roma, 45 | Via Roma, 45 | | | | 21057 Olgiate Olona | 21057 Olgiate Olona | | | | VA - Italia | VA - Italia | | | 510 (k) number | K160166 | | | | Indication for use | X-MIND trium is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, indicated for use in: - producing panoramic X-ray images for diagnostic examination of dentition (teeth), jaws and oral structures; - producing radiographs of maxillofacial region and parts of the skull for cephalometric examination, if equipped with CEPH arm; - producing radiographs of hands and wrists for carpus examination, if equipped with CEPH arm; | X-MIND trium is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, indicated for use in: - producing panoramic X-ray images for diagnostic examination of dentition (teeth), jaws and oral structures; - producing radiographs of maxillofacial region and parts of the skull for cephalometric examination, if equipped with CEPH arm; - producing radiographs of hands and wrists for carpus examination, if equipped with CEPH arm; | same | | | | | | | Rev. n. 2 | X-MIND trium 510 (k) | VOL. 005 | |------------|----------------------|---------------| | 10/01/2020 | | Page 21 of 58 | {24}------------------------------------------------ Image /page/24/Picture/0 description: The image shows the word "ACTEON" in bold, sans-serif font. A blue curved line is underneath the word. The word is likely a company logo. Via Roma, 45 # X-MIND trium VOL. 005 510(k) Summary 002_k Summary 21057 Olgiate Olona (VA) | Characteristic | Predicate | Proposed | Change Id | |-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | | X-MIND trium | X-MIND trium | | | | - producing tomographic images of the oral and maxillofacial region, for diagnostic examination of dentition (teeth), jaws, oral structures and some cranial bones, if equipped with CBCT option. | - producing tomographic images of the oral and maxillofacial region, for diagnostic examination of dentition (teeth), jaws, oral structures and some cranial bones, if equipped with CBCT option. | | | Performance specifications | 1) Panoramic | 1) Panoramic | same | | | 2) Cephalometric (optional) | 2) Cephalometric (optional) | | | | 3) CBCT (optional) | 3) CBCT (optional) | | | | 1) PAN: | 1) PAN: | same | | | - standard panoramic | - standard panoramic | | | | - child panoramic | - child panoramic | | | | - TMJ | - TMJ | | | Exam mode | - bitewing | - bitewing | | | | - sectorial panoramic with improved orthogonality | - sectorial panoramic with improved orthogonality | | | | - maxillary sinuses | - maxillary sinuses | | | | 2) CEPH: | 2) CEPH: | | | | - frontal (AP/PA) | - frontal (AP/PA) | | | | - lateral (LL) | - lateral (LL) | | | | - hand acquisition – carpus (special support needed) | - hand acquisition – carpus (special support needed) | | | Rev. n. 2 | | VOL. 005 | |------------|----------------------|---------------| | | X-MIND trium 510 (k) | | | 10/01/2020 | | Page 22 of 58 | {25}------------------------------------------------ Image /page/25/Picture/0 description: The image shows the word "ACTEON" in bold, sans-serif font. A blue swoosh design is on the left side of the word. The word is in all caps and is slightly angled upwards from left to right. VOL. 005 002_k Summary Via Roma, 45 21057 Olgiate Olona (VA) 510(k) Summary Summary | Characteristic | Predicate | Proposed | Change Id | |-----------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------|--------------| | | X-MIND trium | X-MIND trium | | | | 3) CBCT: - full view - extended view | 3) CBCT: - full view - extended view | | | Type of power supply | Single-phase alternating current power supply | Single-phase alternating current power supply | same | | Nominal voltage | 100 V - 240V | 100 V - 240V | same | | Maximum voltage variation | ±10% | ±10% | same | | Nominal current | 7 A (@ 240 V) 15 A (@ 100 V) | 7 A (@ 240 V) 15 A (@ 100 V) | same | | Frequency | 50 - 60 Hz | 50 - 60 Hz | same | | Operation mode | Continuous operation with intermittent X-ray loading | Continuous operation with intermittent X-ray loading | same | | Protection against electrical shock | Class I | Class I | same | | Degree of protection against electrical shock | Type B | Type B | same | | Emission | Group 1, Class A | Group 1, Class A | same | | Manufacturer of the X-ray tube | Skan X | Skan X | same | | X-ray tube model | CEI OPX/105 | CEI OPX/105 | same | | Nominal High Voltage | 60 - 85 kV for PAN/CEPH | 60 - 85 kV for PAN/CEPH | same | | Rev. n. 2 10/01/2020 | X-MIND trium 510 (k) | VOL. 005 Page 23 of 58 | |-------------------------|----------------------|---------------------------| |-------------------------|----------------------|---------------------------| {26}------------------------------------------------ Image /page/26/Picture/0 description: The image shows the word "ACTEON" in bold, black letters. A blue swoosh design is on the left side of the word. The swoosh starts below the "A" and curves upward and to the right, ending near the top of the "C". VOL. 005 # 510(k) Summary 002_k Summary | Characteristic | Predicate | Proposed | Change Id | |--------------------------------|------------------------------------|------------------------------------|--------------| | | X-MIND trium | X-MIND trium | | | | 80 - 90 kV for CBCT | 80 - 90 kV for CBCT | | | Anode heat storage capacity | 30 kJ | 30 kJ | same | | Nominal focal spot diameter | 0.5 mm | 0.5 mm | same | | Anode material | Tungsten | Tungsten | same | | Target Angle | 5° | 5° | same | | Anodic current | 4 – 10 mA for PAN/CEPH | 4 – 10 mA for PAN/CEPH | same | | | 4 – 10 mA for CBCT | 4 – 10 mA for CBCT | | | Total filtration | 2.8 mm Al for PAN/CEPH at 85 kV | 2.8 mm Al for PAN/CEPH at 85 kV | same | | | 7.0 mm Al for CBCT at 90 kV | 7.0 mm Al for CBCT at 90 kV | | | HVL | 3.4 mm Al for PAN/CEPH at 85 kV | 3.4 mm Al for PAN/CEPH at 85 kV | same | | | 5.2 mm Al for CBCT at 90 kV | 5.2 mm Al for CBCT at 90 kV | | | High Voltage | kV ± 10% | kV ± 10% | same | | Current in the tube | mA ± 20% | mA ± 20% | same | | Exposure time seconds | Seconds ± (5% + 50ms) | Seconds ± (5% + 50ms) | same | | Detector technology | CMOS | CMOS | same | | Detector manufacturer | Hamamatsu | Hamamatsu | same | | Rev. n. 2 | X-MIND trium 510 (k) | VOL. 005 | |------------|----------------------|---------------| | 10/01/2020 | | Page 24 of 58 | {27}------------------------------------------------ Image /page/27/Picture/0 description: The image shows the word "ACTEON" in bold, sans-serif font. A blue curved line is on the left side of the word. The word is likely a logo or brand name. The background is white. VOL. 005 ### 510(k) Summary 002_k Summary #### Via Roma, 45 21057 Olgiate Olona (VA) | Characteristic | Predicate | Proposed | Change Id | |----------------------|---------------------------------------------------------|-------------------------------------------------------------|--------------| | | X-MIND trium | X-MIND trium | | | | PAN: C10500D-42 | PAN: C10500D-70 | 1 | | Detector model | CBCT: C12280D-40 | PAN/CBCT: C12903D-40G (TLD) | 3 | | | CEPH: C10502D-42 | CEPH: C10502D-70 | 2 | | Pixel size | 100 μm | 100 μm | same | | | | PAN: 1480 px x 2658 px | 1 | | Typical image size | PAN: 1480 px x 2658 px (C10500D-42) | (C10500D-70) PAN: 1400 px x 2658 px | 3 | | | CEPH: 2232 px x 2673 px (C10502D-42) | (C12903D-40G) CEPH: 2232 px x 2673 px (C10502D-70) | 2 | | | | PAN: 148 mm x 6 mm | 1 | | Active area | PAN: 148 mm x 6 mm (C10500D-42) | (C10500D-70) PAN: 140 mm x 6 mm | 3 | | | CBCT: 121.6 mm x 123.2 mm (C12280D-40)…