Orthopantomograph OP300
Device Facts
| Record ID | K163423 |
|---|---|
| Device Name | Orthopantomograph OP300 |
| Applicant | Palodex Group OY |
| Product Code | OAS · Radiology |
| Decision Date | Aug 31, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1750 |
| Device Class | Class 2 |
Indications for Use
The Orthopantomograph 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.
Device Story
Software-controlled dental X-ray unit; produces panoramic, cephalometric, and 3D images of dentomaxillofacial, ENT, and airway regions. Input: X-ray projections generated by rotating tube head and sensors around patient head. Operation: Cone beam X-ray technology; pulsed power mode; reconstruction of 3D volumes from 2D projections using Filtered Back Projection (FBP) or Algebraic Reconstruction Technique (ART). Output: 2D and 3D diagnostic images displayed via software (e.g., CLINIVIEW). Used in clinical settings by qualified healthcare professionals. Output aids clinicians in diagnostic support for dental, TMJ, and ENT conditions. Benefits: Provides cross-sectional diagnostic information for treatment planning.
Clinical Evidence
Bench testing included design verification and validation, biocompatibility (ISO 10993-5, 10993-10), and electrical safety/EMC (IEC 60601 series). Clinical evidence consisted of a review of clinical images by qualified clinicians, confirming acceptable diagnostic quality for the intended indications.
Technological Characteristics
X-ray system with CMOS flat panel (3D) and CMOS (pan/ceph) sensors. Focal spot 0.5mm. Imaging modes: Panoramic, Cephalometric, TMJ 3D. 3D reconstruction via FBP or ART. Connectivity: Interfaces to 2D/3D acquisition software. Standards: IEC 60601-1, 60601-1-6, 62366, 60601-2-63, 60601-2-28, 60601-1-2, 60601-1-3.
Indications for Use
Indicated for diagnostic imaging of head, neck, TMJ, dentomaxillofacial, and ENT regions in patients requiring dental or maxillofacial radiographic examination. Operated by qualified healthcare professionals.
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
Submission Summary (Full Text)
{0}------------------------------------------------
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing, abstract design connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 31, 2017
PaloDEx Group Oy % Mr. Eric Schwandt Regulatory Manager Nahkelantie 160 Tuusula. FI-04300 FINLAND
Re: K163423
Trade/Device Name: Orthopantomograph OP300 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: July 24, 2017 Received: August 3, 2017
Dear Mr. Schwandt:
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. 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 (reporting of medical device
{1}------------------------------------------------
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael D. O'Hara
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 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: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K163423
Device Name Orthopantomograph OP300
#### Indications for Use (Describe)
The Orthopantomograph 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.
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."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the words "Palodex Group" in a simple, sans-serif font. The word "Palodex" is in a larger font size and is positioned above the word "Group". The word "Group" is slightly offset to the right compared to "Palodex".
# 510(k) SUMMARY for Orthopantomograph OP300
# Submitter Information:
Palodex Group Oy Nahkelantie 160 FI-04300 Tuusula Finland
| Contact Person: | Eric Schwandt |
|-------------------|------------------|
| Telephone Number: | +358 10 270 2000 |
| Fax Number: | +358-10-270 5263 |
| Date Prepared: | November 17, 2016 |
|----------------|-------------------|
| Updated: | July 21, 2017 |
## Device Name:
| Proprietary Name: | Orthopantomograph OP300 |
|----------------------|-------------------------------------|
| Common Name: | X-ray, Tomography, Computed, Dental |
| Classification Name: | Computed tomography x-ray system |
| CFR Number: | 892.1750 |
| Device Class: | II |
| Product Code: | OAS |
## Predicate Devices:
| Proprietary Name: | Scanora 3D |
|----------------------|-------------------------------------|
| 510(k) Number | K110839 |
| Common Name: | X-ray, Tomography, Computed, Dental |
| Classification Name: | Computed tomography x-ray system |
| CFR Number: | 892.1750 |
| Device Class: | II |
| Product Code: | OAS |
| Proprietary Name: | Orthopantomograph OP300 |
|----------------------|------------------------------------|
| 510(k) Number | K133544 |
| Common Name: | X-ray, Tomography, Computed, Denta |
| Classification Name: | Computed tomography x-ray system |
| CFR Number: | 892.1750 |
| Device Class: | II |
| Product Code: | OAS |
#### PaloDEx Group Oy
. Street address
Nahkelantie 160 04300 Tuusula Finland
Postal address
P.O. Box 64 ● FI-04301 Tuusula
Finland
Phone
+358 10 270 2000 VAT
BI code FI19774137 1977413-7
Bank Nordea Bank SWIFT NDEAFIHH
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for Palodex Group. The word "Palodex" is in a large, bold, sans-serif font. The word "Group" is in a smaller, sans-serif font and is located below and to the right of "Palodex."
# Description of Device
Orthopantomograph OP300 x-ray unit is a software controlled diagnostic dental X-ray equipment for producing panoramic, cephalometric and 3D images of the dentomaxillofacial complex, ENT and airway regions of the head and neck. The Orthopantomograph OP300 is available in different configurations (panoramic, cephalometric, 3D) with different 3D Field of View configurations (6X4 cm, 6X8 cm, 5X5 cm, 8X8 cm, 8X15 cm, and 13X15 cm). The components of the device include column, carriage, rotating unit (containing tube head, sensors and collimator), top-level hanger, patient head support, software for image reconstruction, and an optional software package for image reviewing. The proprietary name of the optional image reviewing software is CLINIVIEW.
Cone Beam Volumetric Tomography is a medical imaging technique that uses X-rays to obtain crosssectional images of the head or neck. The proposed device utilizes cone beam X-ray technology, which generates conical x-ray beams that rotate around the patient's head and incident upon the receptor that generate sufficiently contrasted images. Quality of the images depends on the level and amount of X-ray energy delivered to the tissue. When interpreted by a trained physician, these images provide useful diagnostic information.
## Indications for Use:
| | Proposed Device<br>Orthopantomograph OP300 | Predicate Device<br>Scanora 3D<br>(K110839) | Predicate Device<br>Orthopantomograph<br>OP300 (K133544) |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The Orthopantomograph<br>OP300 panoramic,<br>cephalometric and cone<br>beam computed tomography<br>x-ray device is intended to<br>image the head and neck<br>areas for diagnostic support.<br>This includes<br>temporomandibular Joints<br>(TMJs) and<br>dentomaxillofacial areas, and<br>with the 13x15 cm field of<br>view (FOV) this additionally<br>includes the ear, nose and<br>throat (ENT) regions. The x-<br>ray device produces<br>conventional 2D x-ray images<br>and x-ray projection images<br>for the reconstruction of a 3D<br>view. The device is operated<br>and used by qualified<br>healthcare professionals. | Scanora 3D is a Cone<br>Beam 3D x-ray system for<br>imaging the head and neck<br>areas, including the ENT<br>and dentomaxillofacial<br>areas, for use in diagnostic<br>support. Dedicated<br>panoramic imaging is an<br>option. A flat panel<br>detector is used to acquire<br>3D images and an optional<br>CCD sensor to acquire<br>panoramic images. The<br>device is operated and<br>used by qualified<br>healthcare professionals. | The OP300 dental<br>panoramic, cephalometric<br>and cone beam computed<br>tomography x-ray device<br>is intended for dental<br>radiographic examination<br>of teeth, jaw and TMJ<br>areas by producing<br>conventional 2D x-ray<br>images as well as x-ray<br>projection images of an<br>examined volume for the<br>reconstruction of a 3D<br>view. The device is<br>operated and used by<br>qualified healthcare<br>professionals. |
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the text "Palodex Group". The word "Palodex" is in a larger font size and is placed above the word "Group". The word "Group" is in a smaller font size and is placed to the right of the word "Palodex".
# Technological Characteristics Comparison
| | Proposed Device | Predicate Device | Predicate Device | | | |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|----------------|---------------------------------------------------------|--------------------------------|
| | Orthopantomograph OP300 | Scanora 3D (K110839) | Orthopantomograph OP300 (K133544) | | | |
| Imaging modes | Panoramic, Cephalometric, TMJ 3D | Panoramic, TMJ 3D | Panoramic, Cephalometric TMJ 3D | | | |
| x-ray source | 3D mode: 90kV<br>Pan mode: 57-90 kV<br>Ceph mode: 60-90 kV<br>kV accuracy: +/-5kV<br>mA range: 3.2-16 mA<br>3D power mode: pulsed | 3D mode: 85 kV<br>Pan mode: 60-81 kV<br>kV accuracy:+/-5 kV<br>mA range: 1-8 mA<br>Power mode: pulsed | 3D mode: 90kV<br>Pan mode: 57-90 kV<br>Ceph mode: 60-90 kV<br>kV accuracy: +/-5kV<br>mA range: 3.2-16 mA<br>3D power mode: pulsed | | | |
| Focal spot | 0.5mm | 0.5 mm | 0.5mm | | | |
| Image detector(s) | CMOS Flat Panel + CMOS for pan/ceph imaging | CMOS Flat Panel + CCD for panoramic imaging | CMOS Flat Panel + CMOS for pan/ceph imaging | | | |
| 3D imaging technique | Reconstruction from 2D images | Reconstruction from 2D images | Reconstruction from 2D images | | | |
| 3D's Field Of View | 40 x 60 mm<br>50 x 50 mm<br>61 x 78 mm<br>78 x 78 mm<br>78 x 150 mm<br>130 x 150 mm | 50 x 50 mm<br>60 x 60 mm<br>75 x 100 mm<br>75 x 145 mm<br>130 x 145 mm | 40 x 60 mm<br>50 x 50 mm<br>61 x 78 mm<br>78 x 78 mm<br>78 x 150 mm<br>130 x 150 mm | | | |
| Available 3D Programs | Field of View | Resolution | Field of View | Resolution | Field of View | Resolution |
| | 40 x 60 mm<br>50 x 50 mm | Low Dose, Standard, High, Endo | 50 x 50 mm<br>60 x 60 mm<br>75 x 100 mm<br>75 x 145 mm<br>130 x 145 mm | Standard, High | 40 x 60 mm<br>50 x 50 mm | Low Dose, Standard, High, Endo |
| | 61 x 78 mm<br>78 x 78 mm<br>78 x 150 mm<br>130 x 150 mm | Low Dose, Standard, High | | | 61 x 78 mm<br>78 x 78 mm<br>78 x 150 mm<br>130 x 150 mm | Low Dose, Standard, High |
| 3D's total viewing angle | 212 degrees | 360 degrees | 200 degrees | | | |
| Pixel size | CMOS flat panel for 3D: 200 μm<br>CMOS for panoramic imaging: 100 μm | CMOS Flat panel for 3D: 200 μm<br>CCD for panoramic imaging: 96 μm | CMOS flat panel for 3D: 200 μm<br>CMOS for panoramic imaging: 100 μm | | | |
| Voxel size | 85-420 μm | 133-350 μm | 85-420 μm | | | |
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the words "Palodex Group" in black font. The word "Palodex" is on the top line and is in a larger font than the word "Group" which is on the second line. The word "Group" is slightly offset to the right.
| Reconstruction<br>technique | Filtered Back Projection<br>(FBP) or<br>Algebraic Reconstruction<br>Technique (ART) | Filtered Back Projection<br>(FBP) or<br>Algebraic Reconstruction<br>Technique (ART) | Filtered Back Projection<br>(FBP) or<br>Algebraic Reconstruction<br>Technique (ART) |
|---------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| 3D's effective<br>exposure time | 1.2 - 12.6 sec | 2.25 - 6 sec | 1.2 - 12.5 sec |
| 3D reconstruction<br>time | 1-3 min | 1 - 5 min | 1-3 min |
| Software Version | OP300 Firmware: 1.28<br>OP300 GUI: 1.9 | Not Known | OP300 Firmware: 1.21<br>OP300 GUI: 1.9 |
| Patient's position | Standing and wheelchair | Sitting | Standing and wheelchair |
| System footprint | H161-241cm x D1390cm x<br>W97-193 cm | H 196 cm<br>D 110 cm<br>W 154 cm | H161-241cm x D1390cm x<br>W97-193 cm |
The proposed Orthopantomograph OP300 also shares the same architectural components and principle of operation as the predicate device Scanora 3D (K110839) including:
- An X-ray source on a motorized rotating unit a.
- b. Collimation of X-ray
- 2D and 3D image detection C.
- Image reconstruction techniques ರ.
- Interfaces to 2D and 3D (3rd party) image acquisition software e.
The technical characteristics of the proposed device and predicate devices, including imaging technology, available Field of Views, technical resolution and other basic technological characteristics are substantially equivalent. Differences in technical characteristics are so small that they do not have any effect on the device performance in practice. As evidenced through the design verification and validation, the proposed Orthopantomograph OP300 can produce 3D images of the maxillofacial (including ENT and airway) areas and the images are of equivalent diagnostic quality as the images with the predicate device Scanora 3D. The slightly bigger Field-of-View of the proposed Orthopantomograph OP300 compared to predicate device Scanora 3D does not neqatively affect imaging of the intended anatomical structures and does not affect substantial equivalence of the device.
### Non-Clinical Performance Data
As part of the design control activities, the Orthopantomograph OP300 device has successfully passed design verification and validation. The substantial equivalence of the proposed Orthopantomograph OP300 for the proposed indications for use has been substantiated via an image comparison study of predicate device Scanora 3D and proposed device Orthopantomograph OP300 images from ENT, airway and maxillofacial areas.
Biocompatibility evaluation was conducted on patient contacting accessory parts and their material and found to be in conformance with ISO 10993-5 and ISO 10993-10.
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the words "Palodex Group" in black font. The word "Palodex" is on the top line and is in a larger font than the word "Group" which is on the second line. The word "Group" is slightly offset to the right compared to the word "Palodex".
EMC and Electrical Safety testing were performed by 30 party test house and found to meet all the requirements in standards IEC 60601-1: 2005. IEC 60601-1-6:2013. IEC 62366:2014. IEC 60601-2-63:2012. IEC 60601-2-28:2010. IEC 60601-1-2:2007. and IEC 60601-1-3:2013.
## Clinical Performance Data:
Clinical images acquired using Orthopantomograph OP300 were reviewed by qualified clinicians to be of acceptable quality for the proposed indications for use.
## Conclusion as to Substantial Equivalence
The indications for use for the proposed device Orthopantomograph OP300 include imaging of head and neck, and ENT. The proposed device has been verified and validated to satisfy the requirements derived from the proposed indications for use. Indications for use of proposed device Orthopantomograph OP300 including imaging of head and neck, and ENT are similar to predicate device Scanora 3D (K110839). As evidenced through the design verification and validation, the proposed Orthopantomograph OP300 can produce 3D images of the maxillofacial (including ENT) areas and the images are of equivalent diagnostic quality as the images with the predicate device Scanora 3D.
Based on the comparison of intended use, principles of operation, technological characteristics, nonclinical and clinical performance data, the minor differences between the proposed Orthopantomograph OP300 with expanded indications for use, and the predicate devices. Scanora 3D (K110839) and Orthopantomograph OP300 (K133544), do not raise new concerns regarding safety and effectiveness for the proposed indications of use. We conclude that the proposed device Orthopantomograph OP300 is substantially equivalent to the predicate devices.
