Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard X-ray imaging device and its capabilities, with no mention of AI or ML technology for image analysis, processing beyond reconstruction, or any other function.

Therapeutic

No.
The device is used for imaging and diagnosis, not for treating any medical condition.

Diagnostic

Yes

The device is explicitly stated to provide "image data for diagnosis."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "X-ray device" and a "panoramic, cephalometric and cone beam CT (CBCT) x-ray device," which are hardware components. The summary also mentions "patient contacting parts" and "electrical safety testing," further indicating a physical device.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The ORTHOPANTOMOGRAPH™ OP 3D LX is an X-ray imaging device. It captures images of the patient's anatomy directly, without requiring any samples to be taken from the body.
Intended Use: The intended use clearly states it's for "imaging of adult and pediatric patients" and "take panoramic, cephalometric or 3D images". This is a diagnostic imaging function, not an in vitro test.
Input Modality: The input modality is "X-ray", which is an imaging technique, not a method for analyzing biological samples.

Therefore, the ORTHOPANTOMOGRAPH™ OP 3D LX falls under the category of medical imaging devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

OAS

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray, CT, Cone Beam CT

Anatomical Site

cranio-maxillofacial complex including the ear, nose and throat (ENT) and airway regions, and cervical spine, carpus imaging, dentomaxillofacial complex and neck area, temporomandibular Joints (TMJs) and dentomaxillofacial areas

Indicated Patient Age Range

adult and pediatric patients

Intended User / Care Setting

qualified healthcare professionals

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

Not Found

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

Not Found

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

Non-Clinical performance bench testing according to international standards for Computed tomography x-ray system has been conducted to determine conformance in regards to various IEC and ISO standards.

A clinical image review was performed in support of establishing substantial equivalence.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K180947, K163423

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

0

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

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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

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 | Similar to
Primary
Predicate | |
| Weight | App. Pan/3D 120 kg
Ceph 155 kg | App. Pan/3D 120 kg
Ceph 155 kg | App. Pan/3D 200 kg
Ceph 240 kg | Identical to
Primary
Predicate | |
| 3D resolution | Low, standard, high,
endo | Low, standard, high,
endo | LDT, standard, high,
endo | Identical to
Primary
Predicate | |
| 2D imaging
programs | Adult Pan, Pediatric
Pan, TMJ, BW,
Segmented | Adult Pan, Pediatric
Pan, TMJ, BW,
Segmented | Adult Pan, Pediatric
Pan, OrthoZone,
Orthogonal Pan, Wide
Arch Pan TMJ, BW,
Carpus | Identical to
Primary
Predicate | |
| Materials
(Patient
contacting
parts) | Cycoloy C2800-96174 | Cycoloy C2800-96174 | Cycoloy C2800
7T5D066 | Similar to
Primary
Predicate | |
| | Grivory GC-4H | Grivory GC-4H | Grivory GC-4H | | |
| | Polycasa PETG | Polycasa PETG | Tyril 790-38771
SUSTARIN C, BLACK,
POM. | | |
| | Grilamid TR 90+ EMD-
802744 MB Black | Grilamid TR 90+ EMD-
802744 MB Black | Silicone 7154MA,
Shore 60 | | |
| | RP450/RP451,
FA5224 (CAS 9002-88-

                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | RP450/RP451,

9

Pal

Group

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Palodex

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Non-Clinical Test Data:

Non-Clinical performance bench testing according to international standards for Computed tomography x-ray system has been conducted to determine conformance in regards to:

IEC 60601-1:2005 / A1:2012 + A2:2020 (Ed. 3.2): Medical electrical equipment -. Part 1: General requirements for basic safety and essential performance
. ANSI AAMIES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014/A1:2020 (Ed. 4.1)CONSOLIDATED VERSION: Medical electrical . equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances -Requirements and tests
IEC 60601-1-3:2008/A1:2013/ A2:2021 (Ed. 2.2): Medical electrical equipment . Part 1-3: General requirements for basic safety and essential performance -Collateral Standard: Radiation protection in diagnostic X-ray equipment
IEC 62304:2006/A1:2015 Edition 1.1 CONSOLIDATED VERSION: Medical device . software – Software life-cycle processes
IEC 60601-1-6:2010/A1:2013/A2:2020 (Ed. 3.2) CONSOLIDATED VERSION: Medical . electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 60601-2-63:2012/ A1:2017/A2:2021 (Ed 1.2): Medical electrical equipment -. Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
IEC 62366-1:2015/A1:2020 (Ed 1.1) CONSOLIDATED VERSION: Medical devices -. Part 1: Application of usability engineering to medical devices
. ISO 10993-1:2018 10993-1 Fifth edition: Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process
. ISO 20417:2021 CORRECTED VERSION 2021-12: Medical devices – Information to be supplied by the manufacturer

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Image /page/12/Picture/0 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, regular, sans-serif font and is positioned to the lower right of "Palodex". The logo is simple and clean, with a focus on the company name.

. ISO 15223-1:2021 (Ed. 4.0): Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
. IEC 61223-3-7:2021 (Ed. 1.0): Evaluation and routine testing in medical imaging departments - Part 3-7: Acceptance and constancy tests - Imaging performance of X-ray equipment for dental cone beam computed tomography
. IEC 61223-3-4:2000(Ed.1.0): Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray equipment
. IEC 60336:2020/COR1:2022: Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics- test methods only
ISO 14971:2019 (3rd Edition): Medical devices Application of risk management to . medical devices

FDA Guidance Documents:

The following list of FDA Guidance Documents were utilized in the development of the ORTHOPANTOMOGRAPH™ OP 3D LX.

Use of International Standard ISO-10993, . Part 1: Evaluation and Testing Within a Risk Management Process", September 4, 2020
. Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions, December 20, 2019
Guidance for the Content of Premarket Submissions for Management of ● Cybersecurity in Medical Devices, October 2, 2014
. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005
. Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices, September 1, 2016
. Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices, September 14, 2018
. Medical X-Ray Imaging Devices Conformance with IEC Standards, February 21, 2023
. Off-The-Shelf Software Use in Medical Devices, September 27, 2019
. Pediatric Information for X-ray Imaging Device Premarket Notifications, November 28, 2017

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Image /page/13/Picture/0 description: The image shows the word "Palodex" in a large, bold, sans-serif font. Below and to the right of "Palodex" is the word "Group" in a smaller, sans-serif font. The text is black against a white background.

Clinical Performance Data:

A clinical image review was performed in support of establishing substantial equivalence.

Conclusion as to Substantial Equivalence:

Based on a comparison of intended use, indications, material composition, technological characteristics, principle of operation, features and performance data, the ORTHOPANTOMOGRAPH™ OP 3D LX is deemed to be substantially equivalent to the predicate device.