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 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.

AI/ML Overview

The provided text describes the regulatory clearance for the Orthopantomograph™ OP 3D LX. However, it does not contain specific acceptance criteria, reported device performance metrics against those criteria, or details of a study that proves the device meets such criteria.

The document primarily focuses on establishing substantial equivalence to predicate devices (ORTHOPANTOMOGRAPH™ OP 3D (K180947) and Orthopantomograph OP300 (K163423)) for regulatory purposes. It lists various non-clinical bench testing standards related to safety, electromagnetic compatibility, radiation protection, software, usability, biocompatibility, and imaging performance, but does not provide the results of these tests or acceptance thresholds.

The "Clinical Performance Data" section merely states: "A clinical image review was performed in support of establishing substantial equivalence." It does not elaborate on the methodology, results, or specific criteria met.

Therefore, I cannot provide the requested information from the given input. The requested details regarding acceptance criteria, reported performance, sample sizes, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are not present in the provided text.

Summary

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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

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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

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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)

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)

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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

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:

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4. Description of Device:

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

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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
Disposablecovers	Intended to serve as a disposable barrier for dentalinstruments to reduce the risk of cross contaminationbetween dental patients.	Palodex Group Oy
Chin rest	Used with bite block or lip support in standard andpediatric imaging to provide patient support	Palodex Group Oy
Bite block	Used with chin rest in standard and pediatric imaging fordentate patients to provide patient support	Palodex Group Oy
Lip support	Used with chin rest in standard and pediatric imaging foredentulous patients and for TMJ imaging to providepatient 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:

The device is operated and used by qualified healthcare professionals.

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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.

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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.

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Device Comparison Table:

Table 5.2: SE Table
DescriptiveInformation	Subject DeviceORTHOPANTOMOGRAPHTM OP 3D LX	Primary Predicate DeviceORTHOPANTOMOGRAPHTM OP 3D (K180947)	Predicate Device #2OrthopantomographOP300(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
RegulationTitle	X-Ray, Tomography,Computed, Dental	X-Ray, Tomography,Computed, Dental	X-Ray, Tomography,Computed, Dental	Same
RegulationClass	Class II	Class II	Class II	Same
Product Code	OAS	OAS	OAS	Same
Indications for Use/Intended Use
Indications forUse	ORTHOPANTOMOGRAPHPHTM OP 3D LX is an X-ray device that isintended to be used forimaging of adult andpediatric patients. Thedevice can beconfigured to takepanoramic,cephalometric or 3Dimages of cranio-maxillofacial complexincluding the ear, noseand throat (ENT) andairway regions, andcervical spine. Thedevice can beconfigured to takecarpus images.The device is operatedand used by qualifiedhealthcareprofessionals.	ORTHOPANTOMOGRAPHPHTM OP 3D is an x-raydevice that is intended tobe used for imaging ofadult and pediatricpatients. The device canbe configured to takepanoramic,cephalometric, or 3Dimages of the cranio-maxillofacial complex foruse in diagnosticsupport.The device can also beconfigured to takecarpus images.ORTHOPANTOMOGRAPHPHTM OP 3D must onlybe used and operated bydentist and otherqualified professionals.	ORTHOPANTOMOGRAPHTM OP300panoramic,cephalometric andcone beam computedtomography x-raydevice is intended toimage the head andneck areas fordiagnostic support.This includestemporomandibularJoints (TMJs) anddentomaxillofacialareas, and with the13x15 cm field of view(FOV) this additionallyincludes the ear, noseand throat (ENT)regions. The x-raydevice producesconventional 2D x-rayimages and x-rayprojection images forthe reconstruction of a3D view. The device isoperated and used byqualified healthcareprofessionals.	SameIndication forUse asPrimaryPredicate andPredicate #2and expressedthrough asimilar choiceof words.
Technological Characteristics
Imagingmodes	Panoramic, TMJ, BW,3D (CBCT),cephalometric	Panoramic, TMJ, BW,3D (CBCT),cephalometric	Panoramic, TMJ,3D(CBCT),cephalometric	Identical toPrimaryPredicate
X-ray source	3D mode: 95kVPan mode: 60-90 kVCeph mode :60-95kV	3D mode: 95kVPan mode: 60-90 kVCeph mode :60-95kV	3D mode: 90kVPan mode: 57-90 kVCeph mode: 60-90 kV	Similar toPrimaryPredicate
	kV accuracy: +/-5kV	kV accuracy: +/-5kV	kV accuracy: +/-5kV
DiscriptiveInformation	Subject DeviceORTHOPANTOMOGRAPHTM OP 3D LX	Primary Predicate DeviceORTHOPANTOMOGRAPHTM OP 3D (K180947)	Predicate Device #2OrthopantomographOP300(K163423)	Comparison
	mA range: 2-16 mA3D power mode:continuous/pulsed	mA range: 1-16 mA3D power mode:continuous/pulsed	mA range: 3.2-16 mA3D power mode:pulsed
Focal spot	0.5 mm	0.5 mm	0.5 mm	Identical toPrimaryPredicate
Imagedetector(s)	TFT Flat Panel DetectorFXDD-1724RA (Vivix-D1724R)(2D and 3D)	CMOS Flat PanelCD41M115 (3D)CMOS detectorCD51M114/CD52M21X(2D)	CMOS Flat PanelC10900D-05 (3D)CMOS detectorC10500D/C10502D(2D)	Similar toPrimaryPredicate
Imagedetectorscintillator	CsI	CsI	CsI	Same
2D imagingperformance- DQE70kV, RQA5	55% @ 1lp/mm40% @ 2lp/mm	45% @ 1lp/mm30% @ 2lp/mm	N/A	Similar toPrimaryPredicate
2D imagingperformance- MTF70kV, RQA5	60% @ 1lp/mm30% @ 2lp/mm	60% @ 1lp/mm30% @ 2lp/mm	N/A	Identical toPrimaryPredicate
3D imagingtechnique	Reconstruction from 2Dimages	Reconstruction from 2Dimages	Reconstruction from2D images	Identical toPrimaryPredicate
3D's Field OfView (FOV)	5 x 5 cm6 x 9 cm8 x 8 cm10 x 10 cm12 x 15 cm (optional)15 x 20 cm (optional)	5 x 5 cm6 x 9 cm9 x 11 cm9 x 14 cm (optional)	4 x 6 cm5 x 5 cm6.1 x 7.8 cm7.8 x 7.8 cm7.8 x 15 cm13 x 15 cm	Similar toPrimaryPredicateSimilar toPredicate #2(biggest FOV)
3D's totalviewing angle	360°	360°	360°	Identical toPrimaryPredicate
Pixel size	Flat Panel Detector95μm (2D)190 μm (3D)	CMOS PAN & 3Dcombo flat panel:3D pixel size: 198 μmpan/ceph pixel size:99μm	CMOS flat panel for3D: 200 μmCMOS for panoramicimaging: 100 μm	Similar toPrimaryPredicate
Voxel size	80–400 μm	80 - 400 μm	85-420 μm	Identical toPrimaryPredicate
Reconstruction Software	Filtered Back Projection(FBP)	Filtered Back Projection(FBP)	Filtered BackProjection (FBP)	Identical toPrimaryPredicate
DiscriptiveInformation	Subject DeviceORTHOPANTOMOGRAPHTM OP 3D LX	Primary Predicate DeviceORTHOPANTOMOGRAPHTM OP 3D (K180947)	Predicate Device #2OrthopantomographOP300(K163423)	Comparison
3D's effectiveexposuretime	1,7-20 sec	1,7-20 sec	1.2 - 12.6 sec	Identical toPrimaryPredicate
Cephexposuretime	8.1-10.5 s	8.1–10.5 s	6,5-20s	Identical toPrimaryPredicate
Patient'sPosition	Standing and wheelchair	Standing and wheelchair	Standing andwheelchair	Identical toPrimaryPredicate
Systemfootprint(includes theoperator)	H169-244cm xD 124-149cm x 167cm	H167-247cm x D124-149cm x 167 cm	H161-241cm xD1390cm x W97-193cm	Similar toPrimaryPredicate
Weight	App. Pan/3D 120 kgCeph 155 kg	App. Pan/3D 120 kgCeph 155 kg	App. Pan/3D 200 kgCeph 240 kg	Identical toPrimaryPredicate
3D resolution	Low, standard, high,endo	Low, standard, high,endo	LDT, standard, high,endo	Identical toPrimaryPredicate
2D imagingprograms	Adult Pan, PediatricPan, TMJ, BW,Segmented	Adult Pan, PediatricPan, TMJ, BW,Segmented	Adult Pan, PediatricPan, OrthoZone,Orthogonal Pan, WideArch Pan TMJ, BW,Carpus	Identical toPrimaryPredicate
Materials(Patientcontactingparts)	Cycoloy C2800-96174	Cycoloy C2800-96174	Cycoloy C28007T5D066	Similar toPrimaryPredicate
	Grivory GC-4H	Grivory GC-4H	Grivory GC-4H
	Polycasa PETG	Polycasa PETG	Tyril 790-38771SUSTARIN 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 9002-88-4)	RP450/RP451,FA5224 (CAS 9002-88-4)	STAMSKIN 07421RED
	PLA MP BIO	PLA MP BIO	Udel P-1700 CL2611Altuglas V825T-101
		Ultradur B2550 FC+EMD-802744 MB Black
Energysource	Mains AC	Mains AC	Mains AC	Identical toPrimaryPredicate
Performance Testing
Usability	Designed and tested forIEC 60601-1-6 and IEC62366	Designed and tested forIEC 60601-1-6 and IEC62366	Designed and testedfor IEC 60601-1-6	Identical toPrimaryPredicate
DiscriptiveInformation	Subject DeviceORTHOPANTOMOGRAPHTM OP 3D LX	Primary Predicate DeviceORTHOPANTOMOGRAPHTM OP 3D (K180947)	Predicate Device #2OrthopantomographOP300(K163423)	Comparison
Software	Designed and tested forIEC 62304	Designed and tested forIEC 62304	Designed and testedfor IEC 62304	Identical toPrimaryPredicate
Biocompatibility	Biocompatible per ISO10993-1:2018	Biocompatible per ISO10993-1:2018	Biocompatible per ISO10993-1:2018	Identical toPrimaryPredicate

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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
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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.

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.