Dental Cone-beam Computed Tomography

K232710 · Yian Medical Technology (Haining) Co., Ltd. · OAS · Jan 9, 2024 · Radiology

Device Facts

• Record ID: K232710
• Device Name: Dental Cone-beam Computed Tomography
• Applicant: Yian Medical Technology (Haining) Co., Ltd.
• Product Code: OAS · Radiology
• Decision Date: Jan 9, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Dental Cone-beam Computed Tomography (Model:iDT901X1) is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, at the direction of healthcare professionals as diagnostic support for adult and pediatric patients. This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height; these height and weight measurements approximately correspond to that of an average 5 year old.

Device Story

Device (iDT901X1) performs CBCT, panoramic, and cephalometric radiography; inputs X-ray cone-beam radiation through dental/maxillofacial anatomy; transforms signals via FPD (TFT/CsI) receptor and image processing workstation into digital images. Used in clinical settings by healthcare professionals; output displayed on monitor for diagnostic assessment. Facilitates clinical decision-making by providing anatomical visualization; benefits patients through diagnostic support for dental/oral/maxillofacial conditions. System comprises frame, X-ray generator, receptor, and software workstation.

Clinical Evidence

Clinical evaluation based on review of sample clinical images by a US radiation-board certified radiologist. Radiologist independently scored essential image quality items across various scanning modes for both adult and pediatric cases. Results indicated acceptable overall image quality for all cases and image types.

Technological Characteristics

CBCT X-ray system; FPD (TFT) with CsI scintillator; 60-120kV tube voltage; 1-20mA tube current; 0.5mm focal spot. Connectivity via DICOM. Software workstation for image acquisition/processing. Complies with IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-63, and ISO 10993 series for biocompatibility.

Indications for Use

Indicated for adult and pediatric patients (≥21 kg, ≥113 cm) requiring 2D (panoramic, cephalometric) or 3D digital X-ray imaging of the dental, oral, and maxillofacial regions for diagnostic support.

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

• PreXion3D Explorer PRO, Model P03B (K221525)

Submission Summary (Full Text)

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January 9, 2024

Yian Medical Technology (Haining) Co., Ltd. % Lili Yan Director of Regulatory Affair Center Yian Medical Technology (Haining) Co., Ltd 1st Floor Area 1, 2nd Floor Area 1, Building A, No. 2 Caohejing Road, Haining Economic Development Zone JIAXING, ZHEJIANG 314400 CHINA

Re: K232710

Trade/Device Name: Dental Cone-beam Computed Tomography Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: OAS Dated: December 14, 2023 Received: December 26, 2023

Dear Lili Yan:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known) K232710

Device Name Dental Cone-beam Computed Tomography

#### Indications for Use (Describe)

Dental Cone-beam Computed Tomography (Model:iDT901X1) is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, at the direction of healthcare professionals as diagnostic support for adult and pediatric patients.

This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height; these height and weight measurements approximately correspond to that of an average 5 year old.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial, sans-serif;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image contains a logo for Yian Medical. The logo consists of a stylized letter "N" in green, followed by the Chinese characters for "Yian Medical" in gray. Below the Chinese characters is the English text "YIAN MEDICAL" in gray.

# 510(k) Summary K232710

| Date Prepared: | Jun 30, 2023 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Yian Medical Technology (Haining) Co., Ltd<br>1st Floor Area 1, 2nd Floor Area 1, Building A, No.<br>2 Caohejing Road, Haining Economic<br>Development Zone, Haichang Street, Haining City,<br>Jiaxing City, Zhejiang Province, China |
| Contact Person: | Lili YAN<br>Director of Regulatory Affair Center<br>Yian Medical Technology (Haining) Co., Ltd<br>Tel: [phone] |

E-mail: [e-mail]

### Identification of the Device:

| Proprietary/Trade Name: | / |
|-------------------------|--------------------------------------|
| Device Name: | Dental Cone-beam Computed Tomography |
| Classification Name: | Computed tomography x-ray system |
| Regulatory Number: | 21 CFR Part 892.1750 |
| Product Code: | OAS |
| Device Class: | Class II |
| Review Panel: | Radiology |

### Identification of the Legally Marketed Predicate Device:

| Trade Name: | PreXion3D Explorer PRO, Model P03B |
|--------------------------|------------------------------------|
| Classification Name: | Computed tomography x-ray system |
| Regulatory Number: | 21 CFR Part 892.1750 |
| Product Code: | OAS |
| Device Class: | Class II |
| Review Panel: | Radiology |
| Submitter/510(k) Holder: | PreXion Corporation |
| Clearance: | K221525 (cleared July 22, 2022) |

# Device Description:

( Product Name: Dental Cone-beam Computed Tomography, The product Model:iDT901X1) uses cone-beam computed tomography (CBCT) through X-ray cone-beam, panoramic radiography, cephalometric radiography to produce images of

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Image /page/4/Picture/0 description: The image contains a logo for Yian Medical. The logo consists of a stylized letter "N" in green and gray, followed by the Chinese characters "奕安医疗" in gray. Below the Chinese characters, the words "YIAN MEDICAL" are written in gray.

the dental, oral and maxillofacial areas to provides diagnostic details for the medical facilities. This product consists of Frame, X-ray generator (including Integrated X-ray source tube head, X-ray tube,Collimator), Image receptor and Image processing system (including Computer, Monitor, Software workstation).

#### Indications for Use:

Dental Cone-beam Computed Tomography (Model:iDT901X1) is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, at the direction of healthcare professionals as diagnostic support for adult and pediatric patients.

This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height; these height and weight measurements approximately correspond to that of an average 5 year old.

# Standards:

- A IEC60601-1 Edition 3.2 2020-08 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- > ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]
- IEC 60601-1-2 Edition 4.1 2020-09 Medical electrical equipment Part 1-2: A General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC /TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment Part > 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
- > IEC 60601-1-3 Edition 2.2 2021-01 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
- > IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- > IEC 62366-1 Edition 1.1 2020-06 Medical devices Part 1: Application of usability engineering to medical devices, including Amendment 1
- > IEC 60601-2-63 Edition 1.1 2017-07 CONSOLIDATED VERSION Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment

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Image /page/5/Picture/0 description: The image contains a logo for Yian Medical. The logo consists of a stylized letter "N" in green and gray, followed by the text "YIAN MEDICAL" in gray. Above the text "YIAN MEDICAL" are three Chinese characters, also in gray.

- > IEC 61223-3-4:2000 Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray equipment
- > IEC 61223-3-7 Edition 1.0 2021-12 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
- > ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems
- A IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION - Medical device software - Software life cycle processes
- > ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- > ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- A ISO 10993-10:2021 Biological evaluation of medical devices Part 10: Tests for skin sensitization
- > ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation
- > ISO 15223-1 Fourth edition 2021-07 Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements
- > ISO 20417: 2021 Medical devices - Information to be supplied by the manufacturer
- > ISO 14971 Third Edition 2019-12 Medical devices - Application of risk management to medical devices
- > Health informatics - Digital imaging and communication ISO 12052:2017 in medicine (DICOM) including workflow and data management
- > IEC 60825-1:2014 Edition 3.0 Safety of laser products - Part 1: Equipment classification and requirements

# FDA Guidance Documents:

- Format for Traditional and Abbreviated 510(k)s Guidance issued on September A 13,2019
- A Electromagnetic Compatibility (EMC) of Medical Devices Guidance for Industry and Food and Drug Administration Staff JUNE 2022
- A Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance for Industry and Food and Drug Administration Staff NOVEMBER 2017
- A Premarket Assessment of Pediatric Medical Devices Guidance for Industry and FDA Staff MARCH 2014

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Image /page/6/Picture/0 description: The image contains a logo for Yian Medical. The logo consists of a stylized letter "N" in green and gray, followed by the company name in Chinese characters and English text. The English text reads "YIAN MEDICAL" in gray, with the Chinese characters above it.

- > Content of Premarket Submissions for Device Software Functions Guidance for Industry and Food and Drug Administration Staff JUNE 2023
- > Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices Guidance for Industry and Food and Drug Administration Staff SEPTEMBER 2016
- A Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Guidance for Industry and Food and Drug Administration Staff SEPTEMBER 2023

# Performance standard:

- A 21CFR PART 1010 PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL
- 21 CFR 1020.30: Diagnostic x-ray system and their major components A
- > 21 CFR 1020.31: Radiographic Equipment
- 21 CFR 1020.33 Computed tomography (CT) equipment A

# Comparison with Predicate Device:

The Dental Cone-beam Computed Tomography (Model:iDT901X1 ) and its predicate device, have the equivalent intended use, functions and similar physical characteristics, performance characteristics.

# Substantial Equivalence:

The comparison between the overall specifications of predicate device (PreXion3D Explorer PRO, model P03B) and the new device (Dental Cone-beam Computed Tomography (Model:iDT901X1) ) is shown in Table 1. Any differences between the predicate and the new device have no impact on safety or efficacy of the new device and do not raise any new potential or increased safety risks, and the new device is equivalent in performance to existing legally marketed devices :

| | Subject Device | Predicate Device |
|-----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Dental Cone-beam Computed<br>Tomography<br>(Model:iDT901X1 ) | P03B (K221525) |
| Manufacturer | Yian Medical Technology<br>(Haining) Co., Ltd. | PreXion Corporation |
| Trade Name | / | PreXion3D Explorer<br>PRO |
| Product Code | OAS | OAS |
| Regulation | 21 CFR 892.1750 | 21 CFR 892.1750 |
| | Subject Device | Predicate Device |
| | Dental Cone-beam Computed<br>Tomography<br>(Model:iDT901X1) | P03B (K221525) |
| Number | | |
| Regulation Name | OAS: Computed<br>tomography x-ray<br>system | OAS: Computed<br>tomography x-ray<br>system |
| Device<br>Classification<br>Name | X-Ray, Tomography,<br>Computed, Dental | X-Ray, Tomography,<br>Computed, Dental |
| Indications for<br>use | Dental Cone-beam Computed<br>Tomography<br>(Model:iDT901X1 ) is intended<br>to produce two-dimensional<br>digital x-ray images including<br>panoramic and cephalometric<br>image, and three-dimensional<br>digital x-ray images of the<br>dental, oral, maxillofacial<br>region, at the direction of<br>healthcare professionals as<br>diagnostic support for adult and<br>pediatric patients.<br><br>This device is not intended for<br>use on patients less than<br>approximately 21 kg (46 lb) in<br>weight and 113 cm (44.5 in) in<br>height; these height and weight<br>measurements approximately<br>correspond to that of an average<br>5 year old. | PreXion3D Explorer PRO is<br>intended to produce<br>two-dimensional digital x-ray<br>images including<br>panoramic and cephalometric<br>image, and three-dimensional<br>digital x-ray images of the<br>dental, oral, maxillofacial<br>region, ENT (Ear, Nose and<br>Throat) and neck region at the<br>direction of healthcare<br>professionals as diagnostic<br>support for adult and pediatric<br>patients. Cephalometric<br>imaging also includes the<br>hand and wrist to obtain<br>carpus images for growth and<br>maturity assessment.<br>This device is not intended for<br>use on patients less than<br>approximately 21 kg (46 lb)<br>in weight and 113 cm (44.5<br>in) in height; these height and<br>weight measurements<br>approximately<br>correspond to that of an<br>average 5 year old. |
| | Subject Device | Predicate Device |
| | Dental Cone-beam Computed<br>Tomography<br>(Model:iDT901X1) | P03B (K221525) |
| Target Population | Children aged 6 (except<br>infants) to elderly | Children aged 6 (except<br>infants) to elderly |
| Anatomical Site | The dental, oral,<br>maxillofacial region | The dental, oral,<br>maxillofacial region<br>ENT (Ear, Nose and Throat)<br>and neck region |
| Users | Health care professionals | Health care professionals |
| Patient Contact<br>Material | Meet ISO 10993 series standard | Meet ISO 10993 series<br>standard |
| Sterility | Non-sterile | Non-sterile |
| Tube<br>Voltage | 60kV~120kV | 90-110KV |
| Tube<br>Current | 1 mA~20 mA | 1-5.3mA |
| Focal Spot<br>Size | 0.5 | 0.3mm x 0.3mm |
| Pulse<br>Exposure<br>function | Yes | Yes |
| Power | Frequency: 50/60Hz<br>Voltage: 110-120VAC<br>Power: 3.0kVA | Frequency: 50/60Hz<br>Voltage: 110-240VAC<br>Power: 1.0KVA |
| Detector<br>material | FPD (TFT)<br>CsI | FPD (TFT)<br>CsI:Tl / Gd2 O2 S:Tb |
| Pixel Size | 200μm x 200μm (With binning)<br>(CT, Cephalometric)<br><br>100μm x 100μm ( Without<br>binning ) (CT, Panoramic) | 248 μm x248µm (With<br>binning)<br>(CT, CT-Panoramic,<br>Panoramic)<br><br>124 µm x124µm<br>(Without binning)<br>(CT, CT-Panoramic,<br>Panoramic, Ceph) |
| Pixel<br>Number | 1504*1248(With binning) (CT,<br>Cephalometric) | 1024x1280(With<br>binning)<br>(CT, CT-Panoramic) |
| | Subject Device | Predicate Device |
| | Dental Cone-beam Computed<br>Tomography<br>(Model:iDT901X1) | P03B (K221525) |
| | 800*2496(Without<br>binning)<br>(CT) | 2560x2048 (Without<br>binning)<br>(CT, CT-Panoramic,<br>Ceph) |
| | 3008*65(Without<br>binning)<br>(Panoramic) | 1900 x 120<br>(Panoramic) |
| | 1504*1248(With<br>binning)<br>(Cephalometric) | 2560 x 2048<br>(Cephalometric) |
| Size of<br>Area<br>Receiving<br>X-ray | 300.8mm x 249.6mm (CT,<br>CEPH) | 253.95mm x 317.44mm<br>(CT, CT-Panoramic) |
| | 80mm x 249.6mm (CT) | 230mm x 15mm<br>(Panoramic) |
| | 300.8mm x 6.5mm (PANO) | 239mm x 302mm<br>(Ceph) |
| spatial resolution | 5lp/mm | 4lp/mm |
| Number of<br>Bits | 16bits | 16bits |
| SID/SOD | SID: 750mm/490mm | 700mm/ 420mm (CT,<br>CT-Panoramic,<br>Panoramic)<br>1000mm / 840mm<br>(Ceph) |
| Dimension<br>(WxDxH) | Max.<br>1300mm*1272mm*2365mm. | 1,112 mm x 1,558 mm x<br>2330 mm (CT, CTPanoramic,<br>Panoramic)<br>1164 mm x 1690 mm x<br>2330 mm (with Ceph)…