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 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 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).

AI/ML Overview

The provided document is a 510(k) Summary for a Dental Cone-beam Computed Tomography device (Model: iDT901X1). It includes a comparison with a predicate device and a summary of testing conducted. Based on the document, here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of specific quantitative acceptance criteria for image quality and a direct comparison with reported device performance in a tabular format. However, it broadly states that "The overall image quality was acceptable for all cases and image types in various scanning mode for both adult and pediatric" based on a clinical evaluation.

Instead of clear acceptance criteria for image quality, the document lists various standards and guidance documents that the device complies with, which implicitly define performance expectations in relation to safety, electromagnetic compatibility, radiation protection, usability, software lifecycle, and acceptance tests for imaging performance. These standards serve as the basis for the "acceptance criteria" and the device's adherence to them is the "reported device performance."

Here's an interpretation based on the provided text, focusing on performance aspects mentioned in the comparison table and the summary of non-clinical tests:

Acceptance Criterion (Implicit)	Reported Device Performance (Compliance/Characteristic)
Image Quality (General Acceptability)	"The overall image quality was acceptable for all cases and image types in various scanning mode for both adult and pediatric." (Based on clinical evaluation by a radiologist)
Device Performance (Safety & Effectiveness Equivalent to Predicate)	"The Dental Cone-beam Computed Tomography (Model:iDT901X1 ) and its predicate device, have the equivalent intended use, functions and similar physical characteristics, performance characteristics." "The differences between the proposed device and the predicate device will not raise any new issues of safety or effectiveness." "The non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate device."
Electrical Safety	Compliance with IEC60601-1 Edition 3.2 2020-08 and ANSI/AAMI ES:60601-1:2005/A2:2010/AMD2:2021.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2 Edition 4.1 2020-09 and IEC /TR 60601-4-2 Edition 1.0 2016-05.
Radiation Safety/Protection	Compliance with IEC 60601-1-3 Edition 2.2 2021-01 and 21 CFR 1020.30, 21 CFR 1020.31, 21 CFR 1020.33.
Usability	Compliance with IEC 60601-1-6 Edition 3.2 2020-07 and IEC 62366-1 Edition 1.1 2020-06.
Software Life Cycle Processes	Compliance with IEC 62304 Edition 1.1 2015-06.
Performance for Dental X-ray Equipment (General)	Compliance with IEC 60601-2-63 Edition 1.1 2017-07.
Acceptance Tests for Imaging Performance of Dental X-ray Equipment	Compliance with IEC 61223-3-4:2000.
Acceptance Tests for Imaging Performance of X-ray Equipment for Dental Cone Beam Computed Tomography	Compliance with IEC 61223-3-7 Edition 1.0 2021-12.
Biocompatibility	Compliance with ISO 10993-1, -5, -10, -23 series.
Spatial Resolution (comparison to predicate)	Subject Device: 5 lp/mm; Predicate Device: 4 lp/mm. (Subject device meets or exceeds this aspect compared to predicate which implies meeting or exceeding the acceptance criteria if predicate is considered a benchmark)
Scan Time (CBCT, Panoramic, Cephalometric) (comparison to predicate/functional performance)	CBCT: 22s (Predicate: 10-20s); Panoramic: 15s (Predicate: 8-16s); Cephalometric: 2.3s (Predicate: 0.16s). (These are functional characteristics. The document implies these times are acceptable for the intended use and do not raise new safety/effectiveness concerns, even if some are longer than the predicate).
General performance for overall operation by taking and reviewing test images (bench testing summary statement)	"Validation was performed for overall operation by taking and reviewing test images. The non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate device." (This confirms that operational performance was validated and found acceptable, though specific metrics are not detailed.)

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document refers to "a number of sample scans and diagnostic images" for the clinical evaluation. It does not specify the exact number of cases or images used in this "test set."
Data Provenance: Not specified. The document states that the manufacturer is "Yian Medical Technology (Haining) Co., Ltd." in CHINA, but does not explicitly mention the country of origin for the clinical evaluation data. It also does not specify if the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: "One US radiation-board certified experienced radiologists."
Qualifications: "US radiation-board certified experienced radiologists." No specific years of experience are mentioned.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/Not specified. The clinical evaluation was performed by a single radiologist who "studied independently a number of sample scans and diagnostic images to score different essential image quality related items." There is no mention of an adjudication process for consensus or conflict resolution, as only one expert was involved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The clinical evaluation involved a single radiologist.
Effect Size of Human Readers Improvement with AI vs. without AI: Not applicable, as no AI component for image interpretation by human readers is described in the provided sections, nor was an MRMC study conducted. The device is a Dental Cone-beam Computed Tomography system for image acquisition, not an AI software for interpretation assistance.

6. If a Standalone (i.e. Algorithm only without human-in-the-loop performance) was Done

Standalone Performance: The document describes the device as a "Dental Cone-beam Computed Tomography" system, which is a hardware device that produces X-ray images. There is no mention of an independent algorithm or AI component that would have standalone performance separate from human-in-the-loop operation. The "image processing system" is part of the overall device. However, the summary of testing includes "overall operation by taking and reviewing test images" and "image quality was acceptable," which implies an evaluation of the device's intrinsic imaging capabilities.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for the clinical evaluation of image quality was based on expert consensus (or in this case, expert opinion from a single radiologist). The radiologist "scored different essential image quality related items." There is no mention of pathology or outcomes data being used as ground truth.

8. The Sample Size for the Training Set

Training Set Sample Size: The document does not specify a training set sample size. The device is a hardware imaging system with an image processing system, not a machine learning algorithm or AI model that typically requires a distinct training set in the context of diagnostic performance evaluation for regulatory submission. The term "training set" is not used in relation to device performance testing in this document.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as no training set for a machine learning model is mentioned or implied by the document.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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).

{1}------------------------------------------------

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 (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 Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K232710

Device Name Dental Cone-beam Computed Tomography

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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., Ltd1st Floor Area 1, 2nd Floor Area 1, Building A, No.2 Caohejing Road, Haining EconomicDevelopment Zone, Haichang Street, Haining City,Jiaxing City, Zhejiang Province, China
Contact Person:	Lili YANDirector of Regulatory Affair CenterYian Medical Technology (Haining) Co., LtdTel: +86-0573-89739736

E-mail: lili.yan@yian-medical.com

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:

{4}------------------------------------------------

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:

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

{5}------------------------------------------------

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

{6}------------------------------------------------

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 ComputedTomography(Model:iDT901X1 )	P03B (K221525)
Manufacturer	Yian Medical Technology(Haining) Co., Ltd.	PreXion Corporation
Trade Name	/	PreXion3D ExplorerPRO
Product Code	OAS	OAS
Regulation	21 CFR 892.1750	21 CFR 892.1750
	Subject Device	Predicate Device
	Dental Cone-beam ComputedTomography(Model:iDT901X1)	P03B (K221525)
Number
Regulation Name	OAS: Computedtomography x-raysystem	OAS: Computedtomography x-raysystem
DeviceClassificationName	X-Ray, Tomography,Computed, Dental	X-Ray, Tomography,Computed, Dental
Indications foruse	Dental Cone-beam ComputedTomography(Model:iDT901X1 ) is intendedto produce two-dimensionaldigital x-ray images includingpanoramic and cephalometricimage, and three-dimensionaldigital x-ray images of thedental, oral, maxillofacialregion, at the direction ofhealthcare professionals asdiagnostic support for adult andpediatric patients.This device is not intended foruse on patients less thanapproximately 21 kg (46 lb) inweight and 113 cm (44.5 in) inheight; these height and weightmeasurements approximatelycorrespond to that of an average5 year old.	PreXion3D Explorer PRO isintended to producetwo-dimensional digital x-rayimages includingpanoramic and cephalometricimage, and three-dimensionaldigital x-ray images of thedental, oral, maxillofacialregion, ENT (Ear, Nose andThroat) and neck region at thedirection of healthcareprofessionals as diagnosticsupport for adult and pediatricpatients. Cephalometricimaging also includes thehand and wrist to obtaincarpus images for growth andmaturity assessment.This device is not intended foruse on patients less thanapproximately 21 kg (46 lb)in weight and 113 cm (44.5in) in height; these height andweight measurementsapproximatelycorrespond to that of anaverage 5 year old.
	Subject Device	Predicate Device
	Dental Cone-beam ComputedTomography(Model:iDT901X1)	P03B (K221525)
Target Population	Children aged 6 (exceptinfants) to elderly	Children aged 6 (exceptinfants) to elderly
Anatomical Site	The dental, oral,maxillofacial region	The dental, oral,maxillofacial regionENT (Ear, Nose and Throat)and neck region
Users	Health care professionals	Health care professionals
Patient ContactMaterial	Meet ISO 10993 series standard	Meet ISO 10993 seriesstandard
Sterility	Non-sterile	Non-sterile
TubeVoltage	60kV~120kV	90-110KV
TubeCurrent	1 mA~20 mA	1-5.3mA
Focal SpotSize	0.5	0.3mm x 0.3mm
PulseExposurefunction	Yes	Yes
Power	Frequency: 50/60HzVoltage: 110-120VACPower: 3.0kVA	Frequency: 50/60HzVoltage: 110-240VACPower: 1.0KVA
Detectormaterial	FPD (TFT)CsI	FPD (TFT)CsI:Tl / Gd2 O2 S:Tb
Pixel Size	200μm x 200μm (With binning)(CT, Cephalometric)100μm x 100μm ( Withoutbinning ) (CT, Panoramic)	248 μm x248µm (Withbinning)(CT, CT-Panoramic,Panoramic)124 µm x124µm(Without binning)(CT, CT-Panoramic,Panoramic, Ceph)
PixelNumber	1504*1248(With binning) (CT,Cephalometric)	1024x1280(Withbinning)(CT, CT-Panoramic)
	Subject Device	Predicate Device
	Dental Cone-beam ComputedTomography(Model:iDT901X1)	P03B (K221525)
	800*2496(Withoutbinning)(CT)	2560x2048 (Withoutbinning)(CT, CT-Panoramic,Ceph)
	3008*65(Withoutbinning)(Panoramic)	1900 x 120(Panoramic)
	1504*1248(Withbinning)(Cephalometric)	2560 x 2048(Cephalometric)
Size ofAreaReceivingX-ray	300.8mm x 249.6mm (CT,CEPH)	253.95mm x 317.44mm(CT, CT-Panoramic)
	80mm x 249.6mm (CT)	230mm x 15mm(Panoramic)
	300.8mm x 6.5mm (PANO)	239mm x 302mm(Ceph)
spatial resolution	5lp/mm	4lp/mm
Number ofBits	16bits	16bits
SID/SOD	SID: 750mm/490mm	700mm/ 420mm (CT,CT-Panoramic,Panoramic)1000mm / 840mm(Ceph)
Dimension(WxDxH)	Max.1300mm1272mm2365mm.	1,112 mm x 1,558 mm x2330 mm (CT, CTPanoramic,Panoramic)1164 mm x 1690 mm x2330 mm (with Ceph)
Weight	233kg±5kg	230 kg (CT, CTPanoramic,Panoramic, Ceph)
Imaging Mode	CBCT, PANO, CEPH	CT scan, CT-Panoramic,Panoramic scan,Cephalometricradiography
	Subject DeviceDental Cone-beam ComputedTomography(Model:iDT901X1)	Predicate DeviceP03B (K221525)
Panoramic ScanPerformance (ScanTime)	15sec	8-16sec
CephalometricRadiography (ScanTime)	2.3sec	0.16sec
CT Scan Time	22s	10-20sec
CT FOV(VoxelSize)	Diameter 230 mm x 180mm(0.45mm)Diameter 150 mm x 120mm(0.29mm)Diameter 80 mm x 80mm(0.15mm)Diameter 50 mm x50mm(0.097mm)Diameter 50 mm x 50mm(0.071mm)	Diameter 150mm xH156mm (0.100 -0.200mm)Diameter 150mm xH100mm (0.100 -0.200mm)Diameter 100mm xH100mm (0.100 -0.200mm)Diameter 50mm xH50mm (0.100 - 0.200mm)
Software functions	-image acquisition-data management-image display-image processing-System Settings	-Image acquisition-Data management-Display High-resolution 2Dand 3D Images Function-Image Processing Functionincludes Airway measurement-system setting
Software level ofdocumentation	Basic Documentation Level	Basic Documentation Level
	Subject DeviceDental Cone-beam ComputedTomography(Model:iDT901X1)	Predicate DeviceP03B (K221525)
Electrical SafetyStandard	ANSI/AAMI ES60601-1	ANSI/AAMI ES60601-1
ElectromagneticCompatibilityStandard	IEC 60601-1-2	IEC 60601-1-2
Radiation SafetyStandard	IEC 60601-1-3	IEC 60601-1-3
ElectricalEquipmentUsability Safety	IEC 60601-1-6IEC 62366	IEC 60601-1-6IEC 62366
UsabilityEngineeringStandard	IEC 62304	IEC 62304
Software LifecycleProcess StandardEssentialperformance ofdental extra-oralXrayequipmentStandard	IEC 60601-2-63	IEC 60601-2-63
Acceptance tests ofImagingperformanceof dental X-rayequipmentStandard	IEC 61223-3-4	IEC 61223-3-4
Acceptance tests ofImagingperformanceof computedtomography X-rayequipmentStandard	IEC 61223-3-7	IEC 61223-3-5
Laser Safety
	Subject DeviceDental Cone-beam ComputedTomography(Model:iDT901X1)	Predicate DeviceP03B (K221525)
StandardRisk ManagementStandardDICOM StandardBiocompatibilityStandardCompliance	IEC 60825-1ISO 14971ISO 12052:2017ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-23	IEC 60825-1ISO 14971NEMA PS 3.1 - 3.20ISO 10993-1ISO 10993-5ISO 10993-10

{7}------------------------------------------------

Image /page/7/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 for "Yian Medical" in gray. Below the Chinese characters, the English words "YIAN MEDICAL" are also written in gray. The logo is simple and modern, and the use of green and gray gives it a clean and professional look.

{8}------------------------------------------------

Image /page/8/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 a simple, sans-serif font.

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the 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 a simple, sans-serif font.

{10}------------------------------------------------

Image /page/10/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 the English translation "YIAN MEDICAL" in gray. The logo is simple and modern, with a focus on the company name.

{11}------------------------------------------------

Image /page/11/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.

{12}------------------------------------------------

Image /page/12/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.

The subject device and the predicate device are equivalent in the indications for use, patient population, use environment, software functions, software level of documentation and performance characteristics. They are similar in technical specification. The differences between the proposed device and the predicate device will not raise any new issues of safety or effectiveness.

Summary of Testing:

Summary of Non-Clinical Tests: Electrical Safety and Electromagnetic Compatibility Summary

The electrical safety and EMC data included in the submission is in compliance with the following FDA recognized standards:

·IEC60601-1 Edition 3.2 2020-08
•ANSI/AAMI ES:60601-1:2005/A2:2010/AMD2:2021
•IEC 60601-1-2 Edition 4.1 2020-09
•IEC /TR 60601-4-2 Edition 1.0 2016-05
•IEC 60601-1-3 Edition 2.2 2021-01
•IEC 60601-1-6 Edition 3.2 2020-07

{13}------------------------------------------------

Image /page/13/Picture/0 description: The image contains the 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.

•IEC 60601-2-63 Edition 1.2 2017-07

Bench Testing Summary

The verification test results showed compliance with the above standards, regulations and performance standards. Validation was performed for overall operation by taking and reviewing test images. The non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate device.

Summary of Clinical Tests:

The subject device of this premarket submission, sample clinical images were provided to support a decision of substantial equivalence. The iDT901X1 device performance has been clinically evaluated. One US radiation-board certified experienced radiologists has studied independently a number of sample scans and diagnostic images to score different essential image quality related items. The results have been summarized in the image evaluation study report. The overall image quality was acceptable for all cases and image types in various scanning mode for both adult and pediatric.

Conclusion:

The conclusions drawn from the nonclinical tests demonstrate that the subject device, Dental Cone-beam Computed Tomography (Model: iDT901X1) 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.