Who is the manufacturer of Orthopantomograph OP 3D LX?

Palodex Group OY filed the 510(k) submission for Orthopantomograph OP 3D LX (K230505).

What is the FDA product code for Orthopantomograph OP 3D LX?

OAS. It is classified under 21 CFR 892.1750 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Orthopantomograph OP 3D LX?

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

What are the predicate devices for Orthopantomograph OP 3D LX?

ORTHOPANTOMOGRAPH™ OP 3D (K180947); Orthopantomograph OP300 (K163423).

Who can help prepare an FDA 510(k) submission like Orthopantomograph OP 3D LX?

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.

Orthopantomograph OP 3D LX

K230505 · Palodex Group OY · OAS · Jun 9, 2023 · Radiology

Device Facts

Record ID	K230505
Device Name	Orthopantomograph OP 3D LX
Applicant	Palodex Group OY
Product Code	OAS · Radiology
Decision Date	Jun 9, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1750
Device Class	Class 2
Attributes	Pediatric

Intended Use

ORTHOPANTOMOGRAPH™ OP 3D LX is an X-ray device that is intended to be used for imaging of adult and pediatric patients. The device can be configured to take panoramic, cephalometric or 3D images of cranio-maxillofacial complex including the ear, nose and throat (ENT) and airway regions, and cervical spine. The device can be configured to take carpus images. The device is operated and used by qualified healthcare professionals.

Device Story

ORTHOPANTOMOGRAPH™ OP 3D LX is a dental X-ray system for 2D and 3D imaging of the cranio-maxillofacial complex. It captures panoramic, cephalometric, and cone beam CT (CBCT) images. In panoramic/cephalometric modes, a rotating unit scans the patient with a narrow X-ray beam. In 3D CBCT mode, the unit rotates around the head using a rectangular beam to record 2D projections, which are then reconstructed into 3D data. The device is operated by qualified healthcare professionals in a clinical setting. Output consists of digital image data used for diagnosis and treatment planning (e.g., implants, orthodontics, prosthetics). The device aids in early diagnosis and less invasive treatment. It supports standing and wheelchair-bound patients.

Clinical Evidence

Clinical image review performed to support substantial equivalence. No specific clinical trial metrics (e.g., sensitivity/specificity) provided. Bench testing conducted per IEC/ISO standards (e.g., IEC 60601-1, IEC 60601-2-63, IEC 61223-3-7) confirmed imaging performance and safety.

Technological Characteristics

X-ray system with TFT flat panel detector (CsI scintillator). Imaging modes: Panoramic, TMJ, BW, 3D (CBCT), Cephalometric. 3D reconstruction via Filtered Back Projection (FBP). Materials: Cycoloy C2800, Grivory GC-4H, Polycasa PETG, Grilamid TR 90+, PLA MP BIO. Standards: IEC 60601-1, IEC 60601-2-63, ISO 10993-1, IEC 61223-3-7. Connectivity: Digital dental workflow integration.

Indications for Use

Indicated for imaging of adult and pediatric patients to capture panoramic, cephalometric, or 3D images of the cranio-maxillofacial complex, including ear, nose, throat (ENT), airway regions, cervical spine, and carpus.

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

ORTHOPANTOMOGRAPH™ OP 3D (K180947)
Orthopantomograph OP300 (K163423)

Related Devices

K180947 — Orthopantomograph OP 3D · Palodex Group OY · Jun 7, 2018
K240855 — Dental Cone-beam Computed Tomography · Yian Medical Technology (Haining) Co., Ltd. · Apr 25, 2024
K170813 — ORTHOPANTOMOGRAPH OP 3D · Palodex Group OY · Apr 7, 2017
K142247 — RAYSCAN A-EXPERT 3D · Ray Co., Ltd. · Apr 17, 2015
K160525 — RCT700 · Ray Co., Ltd. · Jun 20, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ June 9, 2023 Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Palodex Group OY % Frank Ray Director Regulatory Affairs Nahkelantie 160 Tuusula, Etela-Karjala 04300 FINLAND Re: K230505 Trade/Device Name: Orthopantomograph™ OP 3D LX Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: May 12, 2023 Received: May 12, 2023 Dear Frank Ray: 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. Lu Jiang Lu Jiang, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K230505 Device Name ORTHOPANTOMOGRAPH™ OP 3D LX ### Indications for Use (Describe) ORTHOPANTOMOGRAPH™ OP 3D LX is an X-ray device that is intended to be used for imaging of adult and pediatric patients. The device can be configured to take panoramic, cephalometric or 3D images of cranio-maxillofacial complex including the ear, nose and throat (ENT) and airway regions, and cervical spine. The device can be configured to take carpus images. The device is operated and used by qualified healthcare professionals. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## 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." FORM FDA 3881 (6/20) PSC Publishing Services (301) 443-6740 El {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for Palodex Group. The word "Palodex" is written in a large, bold, sans-serif font. The word "Group" is written in a smaller, sans-serif font and is located to the lower right of the word "Palodex." # Section V - 510(k) Summary for ORTHOPANTOMOGRAPH™ OP 3D LX - 1. Submitter Information: Palodex Group Oy Nahkelantie 160 FI-04300, Tuusula Finland Contact Person: Frank Ray Telephone Number: (+358)10 270 2000 E-mail: frank.ray@envistaco.com Date Prepared: June 9, 2023 #### 2. Device Name: - ORTHOPANTOMOGRAPH™ OP 3D LX Proprietary Name: ● - Manufacturer: . - Common Name: ● - Classification Name: ● - CFR Number: - Device Class: ● - Product Code: #### Predicate Device (Primary): 3. - ORTHOPANTOMOGRAPH™ OP 3D (K180947) Proprietary Name: ● Palodex Group OY Palodex Group Oy 21 CFR 892.1750 II OAS X-Ray, Tomography, Computed, Dental X-Ray, Tomography, Computed, Dental X-Ray, Tomography, Computed, Dental Computed tomography x-ray system Computed tomography x-ray system - Manufacturer: ● - Common Name: - Classification Name: Computed tomography x-ray system ● - CFR Number: ● - Device Class: ● - 21 CFR 892.1750 II OAS Product Code: # Predicate Device #2: ● . ● - Proprietary Name: Orthopantomograph OP300 (K163423) ● Palodex Group OY - Manufacturer: . - Common Name: ● - Classification Name: - CFR Number: ● Device Class: - CFR 892.1750 II - OAS Product Code: {4}------------------------------------------------ #### 4. Description of Device: ORTHOPANTOMOGRAPH™ OP 3D LX manufactured by PaloDEx Group Oy is a panoramic, cephalometric and cone beam CT (CBCT) x-ray device for 2D and 3D imaging of patient's cranio-maxillofacial complex. It can be used to capture 2D and 3D x-ray images from pediatric and adult patients. The Primary Predicate Device ORTHOPANTOMOGRAPH™ OP 3D has already been cleared for panoramic and cone beam CT usage (K180947). The ORTHOPANTOMOGRAPH™ OP 3D LX is an X-ray device that can be configured to take panoramic, cephalometric or 3D images of craniomaxillofacial complex, and neck areas including the ear, nose and throat (ENT). The device can be configured to take carpus images. The device is operated and used by qualified healthcare professionals. The ORTHOPANTOMOGRAPH™ OP 3D LX is intended to be used for imaging of adult and pediatric patients. The ORTHOPANTOMOGRAPH™ OP 3D LX is part of digital dental workflow providing image data for diagnosis and treatment planning for the healthcare professionals. Xray images reveal the targeted craniofacial anatomy, and condition and the position of anatomical structures inside FOV, such as teeth, mandibular joints, and oral and nasal cavities. This helps dentists to prepare for various dental procedures such as implant placement, orthodontics and dental prosthetics, providing possible early diagnosis, which enables early and less invasive treatment. Per the Guidance for Industry and FDA Staff entitled, "Bundling Multiple Devices or Multiple Indications in a Single Submission," dated June 22, 2007, PaloDEx Group Oy is bundling the ORTHOPANTOMOGRAPH™ OP 3D LX models below as they do not differ significantly in purpose, design, materials, energy source, function or any other feature related to substantial equivalence. The device description and intended use are identical for all models listed below. Also the supporting data is relevant to the ORTHOPANTOMOGRAPH™ OP 3D LX as a whole, the bundled device components and accessories are used together during therapeutic procedures, and one review group will be involved. | Model Type | Model Part Numbers | Description | |------------|----------------------------------------|-----------------------| | PCX-1 | 0.805.5753 (SAP) / 901265-PTU (Oracle) | OP 3D LX (PAN 3D) | | PCX-1 | 0.805.5754 (SAP) / 901266-PTU (Oracle) | OP 3D LX (PAN CEPH 3D | Table 5.1: ORTHOPANTOMOGRAPH™ OP 3D LX models ## Principle of Operation / Mechanism of Action: Panoramic imaging is used for acquiring 2D images. In the panoramic mode the rotating unit rotates around patient head and scans the patient with a narrow x-rav beam. Generation of exposure is turned off and turned on during the exposure to produce partial panoramic, bitewing (BW) and TMJ (Temporo Mandibular Joint) images. Cephalometric imaging is performed by utilizing a second x-ray source. System is using same sensor for all imaging modalities. Both the x-ray source and the rotating unit make a scanning movement to produce either lateral cephalometric or PA image of the patient's head by using a narrow x-ray beam. Patient head is positioned in the ceph {5}------------------------------------------------ head support. For carpus imaging there is a dedicated carpus holder to be attached to the ceph head support for supporting the object during exposure. In 3D CBCT mode the rotating unit rotates around patient's head and scans the patient with a rectangular beam, where the beam size is adjusted depending on the selected FOV (Field-of-View) size. Several 2D projection images are recorded during this rotational movement. These 2D images are saved, and based on the data, the 3D data is generated by reconstruction. Once images are reconstructed, they can be viewed in an image viewing software (dental application). The image viewing software is not part of this proposed device. ## Accessories: The Accessories for the ORTHOPANTOMOGRAPH™ OP 3D LX are listed in Table 5.1A below. All Accessories are the same/identical to the cleared Primary Predicate Device ORTHOPANTOMOGRAPH OP 3D (K180947). | Device / Accessory | Description | Manufacturer | |-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------|------------------| | Disposable covers | Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients. | Palodex Group Oy | | Chin rest | Used with bite block or lip support in standard and pediatric imaging to provide patient support | Palodex Group Oy | | Bite block | Used with chin rest in standard and pediatric imaging for dentate patients to provide patient support | Palodex Group Oy | | Lip support | Used with chin rest in standard and pediatric imaging for edentulous patients and for TMJ imaging to provide patient support | Palodex Group Oy | | Head support | Used to provide patient support | Palodex Group Oy | | Carpus holder | Used in carpus imaging to provide patient support | Palodex Group Oy | ## Table 5.1A: Accessories #### ട. Indications for Use: ORTHOPANTOMOGRAPH™ OP 3D LX is an X-ray device that is intended to be used for imaging of adult and pediatric patients. The device can be configured to take panoramic, cephalometric or 3D images of cranio-maxillofacial complex including the ear, nose and throat (ENT) and airway regions, and cervical spine. The device can be configured to take carpus images. The device is operated and used by qualified healthcare professionals. {6}------------------------------------------------ #### 6. Substantial Equivalence: #### Details of the similarities between subject and predicate devices: A The similarities between Subject Device, ORTHOPANTOMOGRAPH™ OP 3D LX, and the Primary Predicate Device, ORTHOPANTOMOGRAPH™ OP 3D (K180947), are listed in Table 12.1 below for Technological Characteristics and Performance Testing. The proposed device ORTHOPANTOMOGRAPH™ OP 3D LX shares the similar architectural components and utilize as ORTHOPANTOMOGRAPH™ OP 3D (K180947). Both devices utilize cone beam x-ray technology to acquire volumetric data. The Conical x-ray beam rotates around the patient's head and incidents upon the receptor and the system generates volumetric data from the 2D projection images, similarly to the predicate device. Image modes, 3D resolutions, exposure times and 2D imaging programs are identical. The reconstruction of 3D images from 2D image data in the proposed device is made using the same reconstruction techniques as in the predicate device. Performance testing were conducted on ORTHOPANTOMOGRAPH™ OP 3D LX. Image quality testing was performed as part of bench testing, and the result indicate that ORTHOPANTOMOGRAPH™ OP 3D LX is substantially equivalent to the predicate devices. Biocompatibility evaluation was conducted on patient contacting parts and their material and found to be in conformance with ISO 10993-1 for both proposed and the predicate device. Software on ORTHOPANTOMOGRAPH™ OP 3D LX is designed according to the manufacturer´s software development quidelines complying with IEC 62304. Testing was performed as part of the electrical safety testing. - A Details of the differences between subject and predicate devices: There are no major differences between the subject device (ORTHOPANTOMOGRAPH™ OP 3D LX) and predicate devices (ORTHOPANTOMOGRAPH™ OP 3D (K180947) and ORTHOPANTOMOGRAPH™ OP300 (K163423)), however there are some minor differences as described below. ## Intended Use/Indications of use: "Ear, nose and throat (ENT) and airway regions, and cervical spine." is not part of the primary predicate intended use/indications of use. Secondary predicate ORTHOPANTOMOGRAPH™ OP300 (K163423) has also "neck area, ear, nose and throat (ENT) regions" included in the intended use/indications of use. Performance testing demonstrates the proposed ORTHOPANTOMOGRAPH™ OP 3D LX and both predicate devices can image the same anatomical areas, that is the dentomaxillofacial complex and neck area which include the airway regions and cervical spine. As a summary ORTHOPANTOMOGRAPH™ OP 3D LX Indications for Use statement is utilizing more descriptive wording to communicate anatomical structures inside the scanned volume. {7}------------------------------------------------ ### X-ray source: The proposed and the predicate devices utilize the same x-ray tube. The chosen technique factors are slightly different. The small difference in the device's tube current is due to the proposed device having longer SID requiring a bit larger current for imaging. ### Image Detectors: The proposed device has only one TFT (Thin Film Transistor) sensor capable of capturing all modalities (panoramic, cephalometric and CBCT image data). Using only one sensor is possible due to the bigger image detector size at the proposed device (Effective detector area 240 x168 mm) compared to the Primary Predicate (Effective detector area 125 x125 mm). TFT imaging performance is similar to CMOS sensors used with the Predicate device and equivalent clinical performance can be achieved. Measured DQE performance is substantially equivalent to the predicate device. ### 3D Field of View: The larger image detector in the proposed device enables bigger field of view options. Field of view options in the proposed device are optimized for clinical needs to achieve intended use of the device. ### Pixel size: The proposed and the primary predicate device have almost identical pixel sizes. 5 um /10 um difference in pixel sizes is not significant in clinical practice. ## System footprint: Minor difference in the adjustable height of the device does not impact the safety or effectiveness of the device. ## Materials (Patient contacting): The proposed device uses the same materials for the patient contacting parts with exception for the head support. ORTHOPANTOMOGRAPH™ OP 3D LX uses "Grilamid TR 90+ EMD- 802744 MB Black" also for the head support and "Ultradur B2550 FC+ EMD-802744 MB Black" is not used. However, these minor differences do not raise new concerns of substantial equivalence. The comparison below (Table 5-2) for the Subject Device and Predicate Devices demonstrates that the Subject device is substantially equivalent to the Primary Predicate with regards to their Indications for use, technology and performance specifications. Furthermore the subject device does not introduce a fundamentally new scientific technology, and nonclinical performance testing demonstrates that the device is substantially equivalent as the Subject device performs as well as the Primary Predicate device for its intended use. {8}------------------------------------------------ # Device Comparison Table: | Table 5.2: SE Table | | | | | | |---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--| | Descriptive Information | Subject Device ORTHOPANTOMOGRAPH TM OP 3D LX | Primary Predicate Device ORTHOPANTOMOGRAPH TM OP 3D (K180947) | Predicate Device #2 Orthopantomograph OP300 (K163423) | Comparison | | | Regulatory Information | | | | | | | Manufacturer | Palodex Group OY | Palodex Group OY | Palodex Group OY | Same | | | Regulation # | 21 CFR 892.1750 | 21 CFR 892.1750 | 21 CFR 892.1750 | Same | | | Regulation Title | X-Ray, Tomography, Computed, Dental | X-Ray, Tomography, Computed, Dental | X-Ray, Tomography, Computed, Dental | Same | | | Regulation Class | Class II | Class II | Class II | Same | | | Product Code | OAS | OAS | OAS | Same | | | Indications for Use/Intended Use | | | | | | | Indications for Use | ORTHOPANTOMOGRAPH PHTM OP 3D LX is an X- ray device that is intended to be used for imaging of adult and pediatric patients. The device can be configured to take panoramic, cephalometric or 3D images of cranio- maxillofacial complex including the ear, nose and throat (ENT) and airway regions, and cervical spine. The device can be configured to take carpus images. The device is operated and used by qualified healthcare professionals. | ORTHOPANTOMOGRAPH PHTM OP 3D is an x-ray device that is intended to be used for imaging of adult and pediatric patients. The device can be configured to take panoramic, cephalometric, or 3D images of the cranio- maxillofacial complex for use in diagnostic support. The device can also be configured to take carpus images. ORTHOPANTOMOGRAPH PHTM OP 3D must only be used and operated by dentist and other qualified professionals. | ORTHOPANTOMOGR APHTM OP300 panoramic, cephalometric and cone beam computed tomography x-ray device is intended to image the head and neck areas for diagnostic support. This includes temporomandibular Joints (TMJs) and dentomaxillofacial areas, and with the 13x15 cm field of view (FOV) this additionally includes the ear, nose and throat (ENT) regions. The x-ray device produces conventional 2D x-ray images and x-ray projection images for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals. | Same Indication for Use as Primary Predicate and Predicate #2 and expressed through a similar choice of words. | | | Technological Characteristics | | | | | | | Imaging modes | Panoramic, TMJ, BW, 3D (CBCT), cephalometric | Panoramic, TMJ, BW, 3D (CBCT), cephalometric | Panoramic, TMJ, 3D(CBCT), cephalometric | Identical to Primary Predicate | | | X-ray source | 3D mode: 95kV Pan mode: 60-90 kV Ceph mode :60-95kV | 3D mode: 95kV Pan mode: 60-90 kV Ceph mode :60-95kV | 3D mode: 90kV Pan mode: 57-90 kV Ceph mode: 60-90 kV | Similar to Primary Predicate | | | | kV accuracy: +/-5kV | kV accuracy: +/-5kV | kV accuracy: +/-5kV | | | | Discriptive Information | Subject Device ORTHOPANTOMOGRAPH TM OP 3D LX | Primary Predicate Device ORTHOPANTOMOGRAPH TM OP 3D (K180947) | Predicate Device #2 Orthopantomograph OP300 (K163423) | Comparison | | | | mA range: 2-16 mA 3D power mode: continuous/pulsed | mA range: 1-16 mA 3D power mode: continuous/pulsed | mA range: 3.2-16 mA 3D power mode: pulsed | | | | Focal spot | 0.5 mm | 0.5 mm | 0.5 mm | Identical to Primary Predicate | | | Image detector(s) | TFT Flat Panel Detector FXDD-1724RA (Vivix-D 1724R) (2D and 3D) | CMOS Flat Panel CD41M115 (3D) CMOS detector CD51M114/CD52M21X (2D) | CMOS Flat Panel C10900D-05 (3D) CMOS detector C10500D/C10502D (2D) | Similar to Primary Predicate | | | Image detector scintillator | CsI | CsI | CsI | Same | | | 2D imaging performance - DQE 70kV, RQA5 | 55% @ 1lp/mm 40% @ 2lp/mm | 45% @ 1lp/mm 30% @ 2lp/mm | N/A | Similar to Primary Predicate | | | 2D imaging performance - MTF 70kV, RQA5 | 60% @ 1lp/mm 30% @ 2lp/mm | 60% @ 1lp/mm 30% @ 2lp/mm | N/A | Identical to Primary Predicate | | | 3D imaging technique | Reconstruction from 2D images | Reconstruction from 2D images | Reconstruction from 2D images | Identical to Primary Predicate | | | 3D's Field Of View (FOV) | 5 x 5 cm 6 x 9 cm 8 x 8 cm 10 x 10 cm 12 x 15 cm (optional) 15 x 20 cm (optional) | 5 x 5 cm 6 x 9 cm 9 x 11 cm 9 x 14 cm (optional) | 4 x 6 cm 5 x 5 cm 6.1 x 7.8 cm 7.8 x 7.8 cm 7.8 x 15 cm 13 x 15 cm | Similar to Primary Predicate Similar to Predicate #2 (biggest FOV) | | | 3D's total viewing angle | 360° | 360° | 360° | Identical to Primary Predicate | | | Pixel size | Flat Panel Detector 95μm (2D) 190 μm (3D) | CMOS PAN & 3D combo flat panel: 3D pixel size: 198 μm pan/ceph pixel size: 99μm | CMOS flat panel for 3D: 200 μm CMOS for panoramic imaging: 100 μm | Similar to Primary Predicate | | | Voxel size | 80–400 μm | 80 - 400 μm | 85-420 μm | Identical to Primary Predicate | | | Reconstructio n Software | Filtered Back Projection (FBP) | Filtered Back Projection (FBP) | Filtered Back Projection (FBP) | Identical to Primary Predicate | | | Discriptive Information | Subject Device ORTHOPANTOMOGRAPH TM OP 3D LX | Primary Predicate Device ORTHOPANTOMOGRAPH TM OP 3D (K180947) | Predicate Device #2 Orthopantomograph OP300 (K163423) | Comparison | | | 3D's effective exposure time | 1,7-20 sec | 1,7-20 sec | 1.2 - 12.6 sec | Identical to Primary Predicate | | | Ceph exposure time | 8.1-10.5 s | 8.1–10.5 s | 6,5-20s | Identical to Primary Predicate | | | Patient's Position | Standing and wheelchair | Standing and wheelchair | Standing and wheelchair | Identical to Primary Predicate | | | System footprint (includes the operator) | H169-244cm x D 124-149cm x 167cm | H167-247cm x D124- 149cm x 167 cm | H161-241cm x D1390cm x W97-193 cm…