eco-x Series (eco-x, eco-x-s)
Device Facts
| Record ID | K211159 |
|---|---|
| Device Name | eco-x Series (eco-x, eco-x-s) |
| Applicant | Hdx Will Corp. |
| Product Code | OAS · Radiology |
| Decision Date | Dec 30, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1750 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
‘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 Story
The eco-x Series is a 4-in-1 digital dental X-ray system (CT, Panoramic, Cephalometric, Model Scan). It uses an X-ray generator and detector rotating around the patient to acquire tomographic data; X-rays are attenuated by dense structures (bone) and pass through low-density tissues. The system reconstructs these inputs into 2D or 3D images for clinical analysis. Operated by dentists, physicians, or X-ray technologists in clinical settings, the device aids in diagnosing dental, orthodontic, and ENT conditions. Output is viewed on compatible 3D viewer software (e.g., Will3D, OnDemand3D, InVivoDental) via DICOM 3.0. The device assists clinicians in visualizing anatomical structures, supporting treatment planning and diagnostic decision-making, ultimately benefiting patients through accurate assessment of oral and maxillofacial health.
Clinical Evidence
No clinical data. Bench testing only. Performance verified via non-clinical testing including thermal, electrical, mechanical safety, and electromagnetic compatibility (IEC 60601 series). Imaging performance assessed per IEC 61223-3-4 and FDA guidance for Solid State X-ray Imaging Devices, comparing MTF and DQE against predicate detectors. Results confirmed the device meets specifications and provides diagnostic image quality equivalent or superior to predicates.
Technological Characteristics
Computed tomography X-ray system. Materials: Tungsten anode. X-ray tube: OX/115-05. Detectors: a-si TFT (CSI) or IGZO-TFT for CT/Pano; CMOS for Ceph. Connectivity: Ethernet/RS232 (no wireless). Laser positioning: Class A (655nm). Filtration: >2.5mmAl (Pano/Ceph), >2.5mmAl + 0.2mm Cu (CBCT). Software: FBP reconstruction. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-63, IEC 61223-3-4.
Indications for Use
Indicated for adult and pediatric patients requiring diagnostic imaging of cranial bone tissue, teeth, jaw, oral structures, skull, cervical bone, and occipital regions for general, orthodontic, ENT, and dentomaxillofacial treatment.
Regulatory Classification
Identification
A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
Submission Summary (Full Text)
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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)
'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.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
| <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|----------------------------------------------------------------------------|
| <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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Image /page/3/Picture/0 description: The image shows the logo for HDX Will. The logo consists of a green and blue square with a white "W" inside, followed by the text "HDX Will" in blue. The text is in a bold, sans-serif font.
> 510(K) Summary K21159
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Image /page/4/Picture/0 description: The image shows the logo for HDX Will. The logo consists of a green and blue square with a white "W" inside, followed by the text "HDX Will" in blue. The text is in a bold, sans-serif font.
# 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,<br>Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do,<br>28161, Korea |
| • Telephone No. | : +82-43-710-7318 (Fax: +82-43-710-7312) |
| • Contact Information | : Jeon, Seunghwa / Manager, HDX WILL CORP.<br>10F, 29, Insadong 5-gil, Jongno-gu, Seoul, 03162, Korea<br>Tel: +82-2-2003-5023<br>Email : 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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Image /page/5/Picture/0 description: The image shows the logo for HDX Will. The logo consists of a green and blue square with a white "W" inside, followed by the text "HDX Will" in blue. The text is in a bold, sans-serif font.
| ● | 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
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.
1) The eco-x Series are classified as shown below.
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Image /page/6/Picture/0 description: The image shows the logo for HDX Will. The logo consists of a blue square with a white "W" in the bottom left corner, with a green curved line above the "W". To the right of the square is the text "HDX Will" in a bold, blue font. The logo is simple and modern, and the colors are clean and professional.
| | | 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)<br>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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Image /page/7/Picture/0 description: The image shows the logo for HDX Will. The logo consists of a green and blue square with a white "W" inside, followed by the text "HDX Will" in blue. The text is in a bold, sans-serif font.
- 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.
2) 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 |
| Dental<br>Arch | 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.
3) Compatible 3D Viewer Program (Optional)
- . Will3D (K Number: K170180)
- . OnDemand3D (K Number: K070464)
- InVivoDental (K Number: K123519)
4) Description of the image detectors used.
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Image /page/8/Picture/0 description: The image shows the logo for HDX Will. The logo consists of a blue square with a white "W" inside, next to the text "HDX Will" in blue. The "W" in the square has a green arc above it.
| 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.<br>LTD. |
| Detector type | TFT:a-si (CSI) Flat panel<br>detector | CMOS Flat panel<br>detector | CMOS |
| Resolution<br>(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)<br>Number | No | No | No |
| 510(k) cleared<br>device including<br>corresponding<br>detector as a<br>component | 1) System name: RCT800<br>2) Manufacturer: RAY CO.,<br>Ltd<br>3) 510(K) Number: K192737 | Xineos-2301S: Not<br>known | 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.
5) 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
- 2. Wavelength : 655nm
- 3. Line type : Accurate Straight
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Image /page/9/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 and a green arc in the upper left corner. To the right of the square is the text "HDX Will" in blue, with the "HDX" being larger than the "Will".
### 5. Indications for Use
'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.
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Image /page/10/Picture/0 description: The image shows the logo for HDXWill. The logo features a green square with a white "W" inside it on the left side. To the right of the square is the text "HDXWill" in a blue, sans-serif font. The text is slightly blurred, but the letters are still legible.
#### 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 equipment<br>that provides CT, Panoramic, Cephalometric, and Model<br>Scan images by using X-Ray scan. It provides 2D images<br>for diagnosing cranial bone tissue including adult and<br>pediatric teeth, jaw, oral structures and skull. Also, it<br>provides 3D images by reconstructing images acquired by<br>capturing cervical bone and occipital regions.<br>In addition, ‘eco-x series' is used as diagnosis for general<br>and/or orthodontic treatment, and also is intended to use for<br>ENT (Ear, Nose, and Throat) and dentomaxillofacial<br>diagnosis. | The DENTRIα Series is a Computed Tomography X-Ray<br>imaging device specialized in diagnosing general dental<br>treatments and orthodontic purpose using Panoramic and<br>Cephalometric images respectively. In addition DENTRIα<br>Series is used in the field of Otolaryngology by capturing<br>360 degree rotation sequence of the head and neck areas,<br>including the ENT and dentomaxillofacial areas, and<br>obtains x-ray images from different angles and calculate<br>though computer-processed to produce 3D x-ray<br>tomographic images. The DENTRIa Series is used by<br>physicians, dentists, and x-ray technologists. |
| Operation Mode | 1) CT<br>2) Panorama<br>3) Cephalo (Scan type) | 1) CT<br>2) Panorama<br>3) Cephalo<br>• One shot type<br>• Scan type |
| X-ray tube assembly | | |
| X-ray tube | OX/115-05 | OPX/105<br>(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: >2.5mmAl<br>2) CBCT:<br>• >2.5mmAl + 0.2mm Cu (≥5.3mmAl at 75kV) | > 2.5 mmAl |
| Anode material | Tungsten | Tungsten |
| Range of<br>X-ray tube voltage<br>settings | 60 - 90 kV | 1) CT: 60 - 110 kV ± 8 %<br>2) Panorama: 60 - 90 kV ± 8 %<br>3) Cephalo<br>• One shot type: 60 - 110 kV ± 8 %<br>• Scan type: 60 - 90 kV ± 8 % |
| Range of<br>X-ray tube current<br>settings | 4 - 10mA ± 10 % | 4 - 10mA ± 10 % |
| range of irradiation<br>time settings | 1) CT(Normal): 8 s, 12 s or 24 s ± 10 %<br>2) Panorama: 1.2-14 s ± 10 %<br>3) Cephalo:<br>• Scan type: 2.6-8 s ± 10 % | 1) CT(Normal): 8 s or 24 s ± 10 %<br>2) Panorama: 14 s and less ± 10 %<br>3) Cephalo<br>• One shot type: 0.5, 1, 1.5, 2 s ± 10 %<br>• Scan type: 8.2 s and less ± 10 % |
| Image Properties | | |
| Detector type | 1) CT, Panorama: a-si TFT or IGZO-TFT<br>2) Cephalo: CMOS | 1) CT, Panorama: Flat panel<br>3) Cephalo<br>• One shot type: Flat panel<br>• Scan type: CCD |
| Pixel size | 1) CT, Panorama: 119 or 95 μm<br>2) Cephalo: 99 or 100 μm | 1) CT, Panorama: 100.1 or 127 μm<br>2) Cephalo<br>• One shot type: 129 μm<br>• Scan type: 27 μm |
| Active area (mm) | 1) CT, Panorama<br>• 149.464 x 149.464 mm2 or | 1) CT:<br>• 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)…
