'eco-x series (eco-x, eco-x-s)' is 4 in 1 digital equipment that provides CT, Panoramic, Cephalometric, and Model Scan images by using X-Ray scan. It provides 2D images for diagnosing cranial bone tissue including adult and pediatric teeth, jaw, oral structures and skull. Also, it provides 3D images by reconstructing images acquired by capturing cervical bone and occipital regions.

In addition, 'eco-x series' is used as diagnosis for general and/or orthodontic treatment, and also is intended to use for ENT (Ear, Nose, and Throat) and dentomaxillofacial diagnosis.

Device Description

This Equipment is a Dental X-Ray imaging device used for diagnostic purpose in dental treatment. The operating principle of this device is obtaining the tomographic images by rotating arm to get the recombination data, X-ray generator and detector rotate around the patient to irradiate the X-ray, and penetrated X-ray is measured by the detector, When the X-ray is irradiated on the teeth area for instance, large amount of X-ray is attenuated because objects such as bones are highly dense, On the contrast, X-ray is more permeable to small molecules with low density such as skin or tissue, so more X-ray would pass through the subject. By measuring data obtained from measuring the X-ray is reconstructed by the software to display and analyze the anatomical structure for the diagnosis purposes.

The eco-x Series consists of 2 different models. The eco-x-s supports cephalometric scan compared with the eco-x, which do not support CEPH mode.

AI/ML Overview

The provided text is a 510(k) Summary for the eco-x Series, a dental X-ray imaging device. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical testing. It does not contain information about acceptance criteria or a study proving that the device meets those criteria, especially in terms of clinical performance or human-in-the-loop studies (MRMC).

The document mentions "non-clinical test summary" and "performance test" related to imaging properties and patient dosage, but these are bench tests and not clinical studies with acceptance criteria for diagnostic performance.

Therefore, I cannot fulfill most of your request as the information is not present in the provided document.

Here's what I can extract based on the limited information related to performance:

1. Table of acceptance criteria and reported device performance:

The document mentions meeting standards like IEC 61223-3-4 for imaging performance and providing MTF and DQE values for detectors. However, it does not explicitly state "acceptance criteria" alongside specific "reported device performance" in a table format for diagnostic accuracy or clinical utility of the device in a human setting. The table below reflects the bench test results compared to predicate devices, rather than clinical acceptance criteria.

Metric (Bench Test)	Acceptance Criteria (Implied by equivalence)	Reported Device Performance (eco-x Series)	Predicate Device #1 (K160140) Performance	Predicate Device #2 (K093590) Performance
CT Mode
CTDIw	Not explicitly stated (implied similar or better than predicate)	8.28 mGy (at FOV Ø 16x9, 0.2mm Cu filter, 90kV, 10mA, 24s)	11.12 mGy (at FOV Ø 10 x 8, 90kV, 10mA)	unknown
Detector MTF (at 1 LP/mm)	Implied similar or better than predicate	55%-60% or 62%-67%	57% or 55%	Unknown
Detector DQE (at 1 LP/mm)	Implied similar or better than predicate	55%-60% or 53%-59%	70% at 0 LP/mm or 58%	Unknown
Panorama Mode
DAP	Not explicitly stated (implied similar or better than predicate)	280.8 mGy·cm² (80kV, 10mA, 14s)	198.8 mGy·cm² (Xineos-1313) or 119.0 mGy·cm² (PaxScan1313DX) (80kV, 10mA, 14s)	unknown
Detector MTF (at 1 LP/mm)	Implied similar or better than predicate	55%-60% or 62%-67%	57% or 55%	Unknown
Detector DQE (at 1 LP/mm)	Implied similar or better than predicate	55%-60% or 53%-59%	70% at 0 LP/mm or 58%	Unknown
Cephalo Mode
DAP (Scan type)	Not explicitly stated (implied similar or better than predicate)	48.6 mGy·cm² (80kV, 10mA, 8s)	26.7 mGy·cm² (One Shot type) or 21.3 mGy·cm² (Scan type) (80kV, 10mA, 8.2s)	unknown
Detector MTF (at 1 LP/mm)	Implied similar or better than predicate	60% or 55%	83.3% at 2 LP/mm (One Shot type) or 70% at 1 LP/mm (Scan type)	Unknown
Detector DQE (at 1 LP/mm)	Implied similar or better than predicate	57% or 50%	38.5% at 0 LP/mm (One Shot type) or 50% at 0 LP/mm (Scan type)	Unknown

Regarding the other points of your request, the document does NOT provide information on:

2. Sample size used for the test set and the data provenance: The document mentions "bench testing" but provides no details on "test sets" in the context of patient data, number of cases, or data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth... and their qualifications: Not applicable as no clinical ground truth establishment is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: No, the document explicitly states "Non-Clinical Test Summary" and focuses on comparison to predicate "technological characteristics" rather than clinical effectiveness or human reader performance. This device is a traditional X-ray imaging system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes "software validation" for the original software and OTS software (image viewer) and mentions an image reconstruction algorithm (FBP). However, it does not refer to an "algorithm only" performance study in the sense of an AI model's diagnostic accuracy. The performance tests mentioned are related to hardware performance (image quality, dose) of the X-ray system itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance tests conducted, the "ground truth" would be physical measurements of image quality parameters (e.g., resolution targets for MTF, dose meters for CTDIw/DAP) and not clinical diagnostic outcomes or expert consensus.
8. The sample size for the training set: Not applicable as this is not an AI/machine learning device with a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) Summary for a medical imaging device, demonstrating substantial equivalence through technical comparisons and bench testing against established standards and predicate devices. It does not include information on clinical acceptance criteria or studies involving human readers or AI performance.

Summary

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HDX WILL Corp. % Jeon Seunghwa Manager 10F, 29, Insadong 5-gil Jongno-gu, Seoul 03162 SOUTH KOREA

Re: K211159

Trade/Device Name: eco-x Series (eco-x, eco-x-s) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: April 15, 2021 Received: April 19, 2021

Dear Jeon Seunghwa:

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 medical devices and radiation-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.

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211159

Device Name eco-x series (eco-x, eco-x-s)

Indications for Use (Describe)

In addition, 'eco-x series' is used as diagnosis for general and/or orthodontic treatment, and also is intended to use for ENT (Ear, Nose, and Throat) and dentomaxillofacial diagnosis.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary K21159

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510(k) Summary of Safety and Effectiveness

This summary of safety and effectiveness information is submitted in accordance with 21 CFR § 807.92.

Date Prepared: Apr. 15. 2021 K-number: K211159

1. Submitter

• Manufacturer	: HDX WILL CORP.
• Address	: #105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro,Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do,28161, Korea
• Telephone No.	: +82-43-710-7318 (Fax: +82-43-710-7312)
• Contact Information	: Jeon, Seunghwa / Manager, HDX WILL CORP.10F, 29, Insadong 5-gil, Jongno-gu, Seoul, 03162, KoreaTel: +82-2-2003-5023Email : shjeon2@iwillmed.com

2. Device Name and Classification

•	Trade Name	: eco-x Series (eco-x, eco-x-s)
•	Regulation Name	: Computed Tomography X-ray System
•	Device Classification	: Class II
•	Product Code	: OAS
•	Regulation Number	: 21 C.F.R. § 892.1750
•	Classification Panel	: Radiology

3. Predicate Device

The predicate devices of the subject device are as follows;

Predicate Device #1

• K Number	: K160140
• Manufacturer	: HDX WILL CORP..
• Trade/Device Name	: DENTRIα Series (DENTRIα, DENTRI-Cα, DENTRI-sα)
• Device Classification	: Class II

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●	Product Code	: OAS
●	Regulation Number	: 21 C.F.R. § 892.1750
●	Regulation Name	: Computed tomography x-ray system
●	Classification Panel	: Radiology

	Predicate Device #2
●	K Number	: K093590
●	Manufacturer	: PLANMECA OY
●	Trade/Device Name	: PLANMECA PROMAX 3D MAX
●	Device Classification	: Class II
●	Product Code	: MUH
●	Regulation Number	: 21 C.F.R. § 872.1800
●	Regulation Name	: Extraoral source x-ray system
●	Classification Panel	: Radiology
●	K Number	: K093590

We are not aware of any design-related recalls regarding the predicate devices. No reference devices were used in this submission.

4. Device Description

The eco-x Series are classified as shown below.

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		eco-x	eco-x-s
Mode	CBCT	●	●
	Model Scan	●	●
	PANO	●	●
	1)CEPH (SCAN)	-	●
Added filter (Cu filter)		0.2 mm
2)Collimator	1-axis	●	●
	4-axis	●	●
Note 1: Detector for CEPH is provided as optional (Xineos-2301S or Pluto0900X)Note 2: One collimator can be assembled to the device according to the user's choice.

CBCT: Capture mode for acquiring CT image. It enables to select the preferable range of capture among below and acquire image.
- Free FOV
- Dental Arch
- Nose
- Ear
PANO (Panorama): Capture mode for acquiring Panoramic image. It enables to select the preferable range of capture among below and acquire image.
- Teeth
- TMJ
CEPH (Cephalo): Capture mode for acquiring Cephalometric image. It enables to select the preferable range of capture among below and acquire image.
- LA
- Frontal (PA)
- Carpus
- Waters View
- SMV

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Model Scan: Capture mode for acquiring Cephalometric image. It enables to select material of model among below and acquire image.
- Impression scan
- Stone model scan

The eco-x Series consists of 2 different models. The eco-x-s supports cephalometric scan compared with the eco-x, which do not support CEPH mode.

FOV Option for CBCT Mode

CT FOV (Field of View) option in the eco-x Series is as follows:

Mode	Patient type	*Collimator type
		1-axis collimator	4-axis collimator
Free FOV	For Child	Min. 3x3 - Max. 10x8	Min. 3x3 - Max. 10x8
	For Adult	Min. 3x3 - Max. 12x9	Min. 3x3 - Max. 12x9
DentalArch	For Child	10x8	10x8
	For Adult	16x9	16x9
Nose	For Child	10x8	10x8
	For Adult	16x9	16x9
Ear	For Child	16x9	14x7
	For Adult	16x9	16x9

① FXDD-0606CA (unit: cm)

There are 2 types of collimators. One is a 1 axis collimator with a fixed beam limiting size, and the other is a 4-axis collimator that could adjust the beam limiting size. Depending on the user's choice, one collimator among these is assembled to the device and provided.

Compatible 3D Viewer Program (Optional)

. Will3D (K Number: K170180)
. OnDemand3D (K Number: K070464)
InVivoDental (K Number: K123519)

Description of the image detectors used.

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Model	eco-x, eco-x-s	eco-x-s
Contents	CBCT / PANO /Model Scan	CEPH
Detector model	FXDD-0606CA	Xineos-2301S	Pluto0900X
Manufacturer	VIEWORKS	Teledyne DALSA	iRay Technology Co.LTD.
Detector type	TFT:a-si (CSI) Flat paneldetector	CMOS Flat paneldetector	CMOS
Resolution(pixels)	1495 x 1495	2305 x 68	2252 x 68
Pixel size (µm)	119	99.0	100
MTF	55%-60% at 1 LP/mm	60% at 1LP/mm	55% at 1LP/mm
DQE	55%-60% at 1 LP/mm	57% at 1LP/mm	50% at 1LP/mm
Active area (mm)	149.5 x 149.5	152.0 x 7.0	250 x 7
A/D Conversion	16 bits	14 bits	16 bits
FDA 510(k)Number	No	No	No
510(k) cleareddevice includingcorrespondingdetector as acomponent	1) System name: RCT8002) Manufacturer: RAY CO.,Ltd3) 510(K) Number: K192737	Xineos-2301S: Notknown	No

The eco-x Series in intended to communicate with the Workstation for the transmission of data through Ethernet cable and RS232 Cable. The CBCT system of eco-x Series does not have any wireless option for the transmission of data.

Laser

The laser is used for patient positioning and is classified as Class A. This technical characteristic is as follows:

1. Optical output : 1mW or less
1. Wavelength : 655nm
1. Line type : Accurate Straight

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5. Indications for Use

In addition, 'eco-x series' is used as diagnosis for general and/or orthodontic treatment, and also is intended to use for ENT (Ear, Nose, and Throat) and dentomaxillofacial diagnosis.

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6. Technological Comparison to Predicate Devices

	Proposed Device	Predicate Device #1
K Number	K211159	K160140
Model	eco-x Series (eco-x, eco-x-s)	DENTRIa Series
Manufacturer	HDX WILL CORP.	HDX WILL CORP.
Intended Use	‘eco-x series (eco-x, eco-x-s)' is 4 in 1 digital equipmentthat provides CT, Panoramic, Cephalometric, and ModelScan images by using X-Ray scan. It provides 2D imagesfor diagnosing cranial bone tissue including adult andpediatric teeth, jaw, oral structures and skull. Also, itprovides 3D images by reconstructing images acquired bycapturing cervical bone and occipital regions.In addition, ‘eco-x series' is used as diagnosis for generaland/or orthodontic treatment, and also is intended to use forENT (Ear, Nose, and Throat) and dentomaxillofacialdiagnosis.	The DENTRIα Series is a Computed Tomography X-Rayimaging device specialized in diagnosing general dentaltreatments and orthodontic purpose using Panoramic andCephalometric images respectively. In addition DENTRIαSeries is used in the field of Otolaryngology by capturing360 degree rotation sequence of the head and neck areas,including the ENT and dentomaxillofacial areas, andobtains x-ray images from different angles and calculatethough computer-processed to produce 3D x-raytomographic images. The DENTRIa Series is used byphysicians, dentists, and x-ray technologists.
Operation Mode	1) CT2) Panorama3) Cephalo (Scan type)	1) CT2) Panorama3) Cephalo• One shot type• Scan type
X-ray tube assembly
X-ray tube	OX/115-05	OPX/105(C.E.I. X-ray tube)
Focal spot size	0.5 mm	0.5 mm
Target angle	15°	5°
Permanent filtration	0.5mmAl	0.5 mmAl (IEC 60522)
	Proposed Device	Predicate Device #1
Total filtration of X-ray tube assembly	1) PANO, CEPH: >2.5mmAl2) CBCT:• >2.5mmAl + 0.2mm Cu (≥5.3mmAl at 75kV)	> 2.5 mmAl
Anode material	Tungsten	Tungsten
Range ofX-ray tube voltagesettings	60 - 90 kV	1) CT: 60 - 110 kV ± 8 %2) Panorama: 60 - 90 kV ± 8 %3) Cephalo• One shot type: 60 - 110 kV ± 8 %• Scan type: 60 - 90 kV ± 8 %
Range ofX-ray tube currentsettings	4 - 10mA ± 10 %	4 - 10mA ± 10 %
range of irradiationtime settings	1) CT(Normal): 8 s, 12 s or 24 s ± 10 %2) Panorama: 1.2-14 s ± 10 %3) Cephalo:• Scan type: 2.6-8 s ± 10 %	1) CT(Normal): 8 s or 24 s ± 10 %2) Panorama: 14 s and less ± 10 %3) Cephalo• One shot type: 0.5, 1, 1.5, 2 s ± 10 %• Scan type: 8.2 s and less ± 10 %
Image Properties
Detector type	1) CT, Panorama: a-si TFT or IGZO-TFT2) Cephalo: CMOS	1) CT, Panorama: Flat panel3) Cephalo• One shot type: Flat panel• Scan type: CCD
Pixel size	1) CT, Panorama: 119 or 95 μm2) Cephalo: 99 or 100 μm	1) CT, Panorama: 100.1 or 127 μm2) Cephalo• One shot type: 129 μm• Scan type: 27 μm
Active area (mm)	1) CT, Panorama• 149.464 x 149.464 mm2 or	1) CT:• 131 x 131 mm2 or
	Proposed Device	Predicate Device #1
	• 95.38 x 168.34 mm²	• 130 x 130 mm
		2) Panorama:
	2) Cephalo	• 6 x 131 mm or
	• 228 x 7 mm or	• 3.94 x 128.78 mm
	• 250 x 7 mm	3) Cephalo
		• One shot type: 193 x 259 mm
		• Scan type: 6.9 x 221 mm
	1) CT:	1) CT:
	• 55%-60% at 1 LP/mm or	• 57% at 1 LP/mm or
	• 62%-67% at 1 LP/mm	• 55% at 1 LP/mm
	2) Panorama:	2) Panorama:
MTF	• 55%-60% at 1 LP/mm or	• 57% at 1 LP/mm or
	• 62%-67% at 1 LP/mm	• 55% at 1 LP/mm
	3) Cephalo (Scan type)	3) Cephalo
	• 60% at 1 LP/mm	• One shot type: 83.3% at 2 LP/mm
	• 55% at 1 LP/mm	• Scan type: 70% at 1 LP/mm
	1) CT:	1) CT:
	• 55%-60% at 1 LP/mm or	• 70% at 0 LP/mm or
	• 53%-59% at 1 LP/mm	• 58% at 1 LP/mm
	2) Panorama:	2) Panorama:
DQE	• 55%-60% at 1 LP/mm or	• 70% at 0 LP/mm or
	• 53%-59% at 1 LP/mm	• 58% at 1 LP/mm
	3) Cephalo (Scan type)	3) Cephalo
	• 57% at 1 LP/mm	• One shot type: 38.5% at 0 LP/mm
	• 50% at 1 LP/mm	• Scan type: 50% at 0 LP/mm
Geometry
		1) CT: 600 mm
SourceDistance (SID)	1) CT, Panorama: 577 mm	2) Panorama: 560 mm
	2) Cephalo: 1596 mm	3) Cephalo:
		• One shot type: 1790 mm
	Proposed Device	Predicate Device #1
		• Scan type: 1783 mm


Formatcompatible	DICOM 3.0 Format compatible	DICOM 3.0 Format compatible
Dose Information
CT Mode	CTDIw=8.28mGyAt FOV Ø 16*9 , 0.2mm Cu filterIrradiation parameters :90kV,10mA, 24s	CTDIw = 11.12mGy(at FOV Ø 10 X 8. Irradiation parameters: 90kV, 10mA)
Panorama	DAP = 280.8 mGy· cm²(Irradiation parameters: 80kV, 10mA, 14s)	- Xineos-1313: DAP = 198.8 mGy· cm²(Irradiation parameters: 80kV, 10mA, 14s)
		- PaxScan1313DX: DAP = 119.0 mGy·cm²(Irradiation parameters: 80kV, 10mA, 14s)
Cephalo	- Scan type, DAP= 48.6 mGy·cm²(Irradiation parameters: 80kV, 10mA, 8s)	One Shot type, DAP = 26.7 mGy·cm²(Irradiation parameters: 80kV, 10mA, 0.5s)
		Scan type, DAP = 21.3 mGy·cm²(Irradiation parameters: 80kV, 10mA, 8.2s)

Table 1: Technological Comparison of Subject Device (i.e., eco-x Series and Predicate Device #1(K160140))

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Image /page/12/Picture/0 description: The image contains the logo for HDX Will. The logo features a green and blue square with a white "W" inside. To the right of the square, the text "HDX Will" is written in a stylized, italicized blue font. The logo appears to be for a company or organization named HDX Will.

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	Proposed Device	Predicate Device #2
K Number	K211159	K093590
Model	eco-x Series (eco-x, eco-x-s)	PLANMECA PROMAX 3D MAX
Manufacturer	HDX WILL CORP.	PLANMECA OY
Intended Use	‘eco-x series (eco-x, eco-x-s)' is 4 in 1 digital equipment thatprovides CT, Panoramic, Cephalometric, and Model Scanimages by using X-Ray scan. It provides 2D images fordiagnosing cranial bone tissue including adult and pediatricteeth, jaw, oral structures and skull. Also, it provides 3D imagesby reconstructing images acquired by capturing cervical boneand occipital regions.	PLANMECA PROMAX 3D MAX is a three dimensional ConeBeam Volumetric Tomography (CBVT) x-ray system, which isintended to produce three-dimensional images of the humanteeth, jaw and skull. The device uses cone shaped x-ray beamprojected on to a flat panel detector, and the examined volumeimage is reconstructed to be viewed in 3D viewing stations. Thedevice is to be operated and used by dentists and other legallyqualified health care professionals.
	In addition, 'eco-x series' is used as diagnosis for general and/ororthodontic treatment, and also is intended to use for ENT (Ear,Nose, and Throat) and dentomaxillofacial diagnosis.
OperationMode	1) CT2) Panorama3) Cephalo (Scan type)	1) 3D2) Smart Pan3) Cephalo· Planmeca ProCephScanning Ceph
X-ray tube assembly
X-ray tube	OX/115-05	Toshiba D-067SB
Focal spotsize	0.5 mm	0.6 mm
Target angle	15°	12°
Permanentfiltration	0.5mmAl	Inherent FiltrationAt least 0.8 mm Al at 50 kV
TotalfiltrationofX-raytube	1) PANO, CEPH: >2.5mmAl2) CBCT:	1) 3D: > 2.5 mm Al+ 0.5 mm Cu2) Smart Pan: > 2.5 mm Al3) Cephalo: > 2.5 mm Al

Table 2: Technological Comparison of Subject Device (i.e., eco-x Series and Predicate Device #2 (K093590))

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Image /page/15/Picture/0 description: The image contains the logo for HDX Will. The logo features a green and blue square with a white "W" inside. To the right of the square, the text "HDX Will" is written in a stylized, italicized blue font. The logo appears to be for a company or organization named HDX Will.

	Proposed Device	Predicate Device #2
assembly	>2.5mmAl + 0.2mm Cu (≥5.3mmAl at 75kV)
Anodematerial	Tungsten	Tungsten
Range of X-ray tubevoltagesettings	60 - 90 kV	1) 3D: 60 – 96 kV ± 5 %2) Smart Pan: 60 - 84 kV ± 5 %3) Cephalo: 60 – 84 kV ± 5 %
range of X-ray tubecurrentsettings	4 - 10mA ± 10 %	1 - 16 mA ± 10 %
Range ofirradiationtime settings	1) CT(Normal): 8 s, 12 s or 24 s ± 10 %2) Panorama: 1.2-14 s ± 10 %3) Cephalo:Scan type: 2.6-8 s ± 10 %	1) 3D: 3.6-24 s ± 10 %2) Smart Pan: 10 s ± 10 %3) Cephalo:• Planmeca ProCeph: 0.1 - 0.8 s ± 10 %• Scanning Ceph:- Normal: 12 - 18.7s ± 10 %• High Speed: 6.4-9.9s ± 10 %
Image Properties
Detector type	1) CT, Panorama: a-si TFT or IGZO-TFT2) Cephalo: CMOS	1) 3D: Flat panel2) Smart Pan: Flat panel3) Cephalo:• Planmeca ProCeph: Flat panel• Scanning Ceph: CCD
Pixel size	1) CT, Panorama: 119 or 95 μm2) Cephalo: 99 or 100 μm	1) 3D: 127 μm2) Smart Pan: 127 μm3) Cephalo:• Planmeca ProCeph: 139 μm

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Image /page/16/Picture/0 description: The image contains the logo for HDX Will. The logo features a green square with a white "W" inside, followed by the text "HDX Will" in a stylized, blue font. The text appears to be slightly italicized, giving the logo a dynamic and modern look.

	Proposed Device	Predicate Device #2
		• Scanning Ceph: 48 μm
Activearea(mm)	1) CT, Panorama• 149.464 x 149.464 mm or• 95.38 x 168.34 mm	1) 3D: 193 x 242 mm2) Smart Pan: 13 x 162 mm
	2) Cephalo• 228 x 7 mm or• 250 x 7 mm	3) Cephalo:• Planmeca ProCeph: 302 x 249 mm• Scanning Ceph: 6 x 292 mm
MTF	1) CT:• 55%-60% at 1 LP/mm or• 62%-67% at 1 LP/mm2) Panorama:• 55%-60% at 1 LP/mm or• 62%-67% at 1 LP/mm3) Cephalo (Scan type)• 60% at 1 LP/mm• 55% at 1 LP/mm	Unknown
DQE	1) CT:• 55%-60% at 1 LP/mm or• 53%-59% at 1 LP/mm2) Panorama:• 55%-60% at 1 LP/mm or• 53%-59% at 1 LP/mm3) Cephalo (Scan type)• 57% at 1 LP/mm• 50% at 1 LP/mm	Unknown
Geometry

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Image /page/17/Picture/0 description: The image shows the logo for HDX Will. The logo consists of a green square with a white "W" inside, followed by the text "HDX Will" in blue. The text is in a bold, sans-serif font and is slightly italicized.

	Proposed Device	Predicate Device #2
SourceImageDistance(SID)	1) CT, Panorama: 577 mm2) Cephalo: 1596 mm	1) 3D: 600 mm2) Smart Pan: 600 mm3) Cephalo: 1700 mm
Formatcompatible	DICOM 3.0 Format compatible	DICOM 3.0 Format compatible
Dose Information
CT Mode	CTDIw=8.28mGyAt FOV Ø 16×9 , 0.2mm Cu filterIrradiation parameters :90kV,10mA, 24s	unknown
Panorama	DAP = 280.8 mGy· cm²(Irradiation parameters: 80kV, 10mA, 14s)	unknown
Cephalo	- Scan type, DAP= 48.6 mGy·cm²(Irradiation parameters: 80kV, 10mA, 8s)	unknown

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Image /page/18/Picture/0 description: The image shows the logo for HDX Will. The logo consists of a blue square with a white "W" in the lower left corner, with a green curved line above the "W". To the right of the square is the text "HDX Will" in blue, with the "HDX" in a larger, bolder font than the "Will".

7. Determination of Substantial Equivalence

The eco-x Series (eco-x, eco-x-s) is substantially equivalent to the predicate devices identified above with respect to intended use, principles of operation, and technological characteristics. From the information provided in table above; it is understood that the subject device does not introduce any new technology and/or indications of use. Therefore, the eco-x Series is considered substantially equivalent to the predicate devices

8. Non-Clinical Test Summary

The eco-x Series (eco-x, eco-x-s) is verified and validated according to the FDA design control requirements, 21 CFR 820. The subject device had been subjected to the applicable safety and performance testing before release to ensure the device meets all its specifications. The quality assurance measures applied to the design and development of the subject device include, but not limited to risk analysis, verification and validation, product specifications and design reviews.

A. Thermal, electrical, mechanical safety & Electromagnetic Compatibility

The eco-x Series complies with the electrical safety and electromagnetic compatibility requirements established by the standards below:

. Electrical Basic Safety and Essential Performance requirements in accordance with IEC 60601-1:2005/AMD1:2012
. Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014
. Radiation Protection In Diagnostic X-Ray Equipment requirements of IEC 60601-1-3:2008/AMD1:2013
. Dental Extra-Oral X-Ray Equipment requirements of IEC 60601-2-63:2012/AMD1:2017
. Acceptance Tests - Imaging Performance of Dental X-Ray requirements of IEC 61223-3-4:2000

The manufacturing facility is in conformance with the relevant EPRC standards as specified in 21 CFR 1020.30, 31 and the records are available for review.

B. Biocompatibility

A biocompatibility test is not necessary when considering the device's characteristics.

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Image /page/19/Picture/0 description: The image shows the logo for HDX Will. The logo consists of a blue square with a white "W" inside, with a green curved line above the "W". To the right of the square is the text "HDX Will" in blue, with the "HDX" and "Will" being slightly blurred. The logo is simple and modern, and the colors are bright and eye-catching.

C. Software Validation

The eco-x Series (eco-x, eco-x-s) utilizes original software and OTS software as an image viewer. The eco-x Series contains MODERATE level of concern software. Software was designed and developed according to a software development process and was verified and validated. The algorithm type of image reconstruction is FBP (Filtered Back Projection).

Software information is provided in accordance with FDA guidance: "The content of premarket submissions for software contained in medical devices, on May 11, 2005."

D. Performance Test

Bench testing was used to assess whether the parameter measured required for describing functionalities related to the dental X-ray device's imaging properties and patient dosage meet the criteria under the designated tolerance. Image quality and dose comparison tests showed the substantial equivalence of the eco-x Series to the predicate device.

Furthermore, imaging performance testing was conducted according to IEC 61223-3-4 standard. The test results show that the eco-x Series met all requirements of the standard.

E. SSXI (Solid State X-ray Imaging) Devices Report

Non-clinical performance was conducted for imaging performance of the proposed detector in accordance with FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices". MTF (Modulation Transfer Function) and DQE (Detective Quantum Efficiency) were tested, measured, and compared with the detectors of the predicate device. Although some specifications of the utilized detectors differed from the predicate devices in terms of detector type, pixel size, active area, MTF and DQE, the diagnostic image quality of the detector is equal or better than those of the predicate devices based on the Non-clinical test results. There are no significant differences in the safety and performance of the detectors.

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Image /page/20/Picture/0 description: The image shows the logo for HDX Will. The logo features a blue square with a white "W" inside, followed by the text "HDX Will" in a bold, blue font. The "W" in the square is partially covered by a green arc.

9. Summary

In conclusion, the conducted tests, as well as all verification and validation activities, demonstrate that the design specifications and technological characteristics of the eco-x Series meet applicable requirements and standards for its safety and effectiveness for the intended use. The testing and validation activities conducted demonstrate that any differences between the subject device and the predicate devices do not raise new or different questions of safety or effectiveness compared to the predicate devices. Therefore, the eco-x Series is substantially equivalent to the predicate devices.

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.