KP-View 3D 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

The product ( Dental Cone-beam Computed Tomography, Model: KP-View 3D) 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, and Software workstation).

AI/ML Overview

The provided document is a 510(k) summary for the Yian Medical Technology (Haining) Co., Ltd. KP-View 3D Dental Cone-beam Computed Tomography system.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a tabular format for the device's performance in the way a clinical study might. Instead, it demonstrates substantial equivalence to a predicate device (iDT901X1 Dental Cone-beam Computed Tomography, K232710) by comparing technical specifications and performance characteristics. The acceptance is based on meeting safety and performance standards relevant to dental X-ray equipment.

Here's a table summarizing key comparable technical and performance characteristics, as presented in the document, which implicitly serve as a basis for acceptance by showing equivalence to the already-cleared predicate:

Feature/Characteristic	Subject Device (KP-View 3D) Performance	Predicate Device (iDT901X1) Performance	Acceptance/Equivalence
Indications for Use	Same as predicate	Same as subject	Equivalent
Target Population	For patients 6 years and older	For patients 6 years and older	Equivalent
Anatomical Site	The dental, oral, maxillofacial region	The dental, oral, maxillofacial region	Equivalent
Users	Health care professionals	Health care professionals	Equivalent
Sterility	Non-sterile	Non-sterile	Equivalent
Tube Voltage	60kV~120kV	60kV~120kV	Equivalent
Tube Current	1mA~20mA	1mA~20mA	Equivalent
Nominal Focal Spot Size	0.5	0.5	Equivalent
Pulse Exposure Function	Yes	Yes	Equivalent
Power	Frequency: 50/60Hz, Voltage: 110-120VAC, Power: 3.0KVA	Frequency: 50/60Hz, Voltage: 110-120VAC, Power: 3.0KVA	Equivalent
Detector Material	FPD (TFT) CsI	FPD (TFT) CsI	Equivalent
Pixel Size	200µm x 200µm (With binning) (CT, Cephalometric); 100µm x 100µm (Without binning) (CT, Panoramic)	200µm x 200µm (With binning) (CT, Cephalometric); 100µm x 100µm (Without binning) (CT, Panoramic)	Equivalent
Pixel Number	Specified for various modes	Specified for various modes	Equivalent
Size of Area Receiving X-ray	Specified for various modes	Specified for various modes	Equivalent
Spatial Resolution	5lp/mm	5lp/mm	Equivalent
Number of Bits	16bits	16bits	Equivalent
SID/SOD	SID: 750mm/490mm	SID: 750mm/490mm	Equivalent
Dimension (WxDxH)	Max.overall dimension 1300mm1272mm2365mm	Max.overall dimension 1300mm1272mm2365mm	Equivalent
Weight	233kg±5kg	233kg±5kg	Equivalent
Imaging Mode	CBCT, PANO, CEPH	CBCT, PANO, CEPH	Equivalent
Panoramic Scan Performance (Scan Time)	15sec	15sec	Equivalent
Cephalometric Radiography (Scan Time)	2.3sec	2.3sec	Equivalent
CT Scan Time	22sec	22sec	Equivalent
CT FOV (Voxel Size)	Various specified diameters/voxel sizes	Various specified diameters/voxel sizes	Equivalent
Software Functions	Image acquisition, data management, image display, image processing, system settings	Image acquisition, data management, image display, image processing, system settings	Equivalent
Software Level of Documentation	Basic Level	Basic Level	Equivalent

The "acceptance criteria" can be inferred to be that the subject device's performance characteristics, as demonstrated through non-clinical bench testing, are equivalent to those of the predicate device, and that it complies with relevant recognized standards for safety and performance (e.g., IEC 60601 series for electrical and radiation safety, IEC 62366 for usability, IEC 62304 for software lifecycle, ISO 14971 for risk management).

2. Sample Size for the Test Set and Data Provenance

The document states, "The subject of this premarket submission, did not require clinical studies to support substantial equivalence." Therefore, there is no test set of patient data from clinical studies. The testing relies on non-clinical bench testing to demonstrate equivalence. The provenance of any underlying data that informed the predicate device's clearance is not mentioned here, as this is a Special 510(k) focused on modifications to an already cleared device.

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

Not applicable, as no clinical study with a test set requiring expert-established ground truth was conducted. The assessment is based on technical equivalence and compliance with standards.

4. Adjudication Method for the Test Set

Not applicable, as no clinical study with a test set was conducted.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a dental cone-beam CT system, not an AI-powered diagnostic software. The submission focuses on hardware and software equivalence for image acquisition and processing.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-only device. It is a medical imaging system. Its performance is assessed through its ability to produce images that meet quality and safety standards, as demonstrated through bench testing.

7. The Type of Ground Truth Used

For non-clinical testing, the "ground truth" would be established by reference to engineering specifications, phantom measurements, and compliance with recognized standards (e.g., image quality metrics like spatial resolution (5lp/mm) measured with phantoms, radiation dose measurements, electrical safety checks).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense. The device is a traditional medical imaging system.

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

Not applicable, as no training set was used.

Summary

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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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 25, 2024

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

Re: K240855

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: March 28, 2024 Received: March 28, 2024

Dear Yan Lili:

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Lu Jiang

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

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Indications for Use

510(k) Number (if known) K240855

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)

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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 and gray, followed by the Chinese characters for "Yian Medical" in gray. Below the Chinese characters, the words "YIAN MEDICAL" are written in gray, in a smaller font.

510(k) Summary

KP-View 3D Dental Cone-beam Computed Tomography (K240855)

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Image /page/4/Picture/1 description: The image contains a logo for Yian Medical. The logo consists of a stylized letter "i" in green and gray, followed by the company name in Chinese characters and English. The English name "YIAN MEDICAL" is written in gray, with the Chinese characters appearing above it.

510(k) Summary K240855

Date Prepared:	March 25, 2024
Submitter:	Yian Medical Technology (Haining) Co., Ltd1st Floor Area 1, 2nd Floor Area 1, Building A, No. 2 Caohejing Road,Haining Economic Development Zone, Haichang Street, Haining City,Jiaxing City, Zhejiang Province, China

Contact Person:	Lili YAN
	Director of Regulatory Affair Center
	Yian Medical Technology (Haining) Co., Ltd
	Tel: +86-0573-89739736
	E-mail: lili.yan@yian-medical.com

Identification of the Device:

Proprietary/Trade Name:	Dental Cone-beam Computed Tomography
Device Name:	Dental Cone-beam Computed Tomography
Model:	KP-View 3D
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:	/
Device Name;	Dental Cone-beam Computed Tomography
Model Name:	iDT901X1
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:	Yian Medical Technology (Haining) Co., Ltd.
Clearance:	K232710 (cleared 8, Jan., 2023)

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Image /page/5/Picture/1 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. The Chinese characters are in gray, and the English name "YIAN MEDICAL" is in a smaller font size below the Chinese characters.

Device Description:

Following modifications were made to the predicate device Dental Cone-beam Computed Tomography, Model: iDT901X1 (K232710). Yian Medical Technology (Haining) Co.,Ltd. submits this special 510(k) to request clearance for the subject device Dental Cone-beam Computed Tomography, Model: KP-View 3D

Item	Cleared deviceiDT901X1 Dental ConeBeam-computed Tomography(K232710)		Modified deviceKP-View 3D Dental ConeBeam-computed Tomography(K240855)
Model	iDT901X1		KP-View 3D
Labeling	Model Name: iDT901X1		Model name: KP-View 3D

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)]

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Image /page/6/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. The English name "YIAN MEDICAL" is written in gray, with the Chinese characters above it.

IEC 60601-1-2 Edition 4.1 2020-09 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
A 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
A 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 A equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
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
A 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
IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION | Medical | device | software | Software life cycle processes
Biological evaluation of medical devices - Part 1: Evaluation and testing ISO 10993-1:2018 within a risk management process
Biological evaluation of medical devices - Part 5: Tests for in vitro ISO 10993-5:2009 cvtotoxicitv
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
A Health informatics - Digital imaging and communication in medicine ISO 12052:2017 (DICOM) including workflow and data management

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Image /page/7/Picture/0 description: The image shows the text "Special 510(k): Device Modification". The text is written in a simple, sans-serif font. The text is centered on the image and takes up most of the space. The background is plain white.

Image /page/7/Picture/1 description: The image contains a logo for Yian Medical. The logo consists of a green stylized letter N on the left, followed by the company name in both Chinese characters and English. The English text "YIAN MEDICAL" is in gray, positioned below the Chinese characters.

IEC 60825-1:2014 Edition 3.0 Safety of laser products Part 1: Equipment classification and > requirements

FDA Guidance Documents:

Electronic Submission Template for Medical Device 510(k) Submissions issued on October 2, A 2023
A The Special 510(k) Programme issued on September 13,2019
A Electromagnetic Compatibility (EMC) of Medical Devices Guidance for Industry and Food and Drug Administration Staff JUNE 2022
Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance for Industry and Food and Drug Administration Staff NOVEMBER 2017
Premarket Assessment of Pediatric Medical Devices Guidance for Industry and FDA Staff MARCH 2014
Content of Premarket Submissions for Device Software Functions issued on June 2023
A Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices issued on September 2016
A Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions issued on September 2023

Performance standard:

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

Comparison with Predicate Device:

The Dental Cone-beam Computed Tomography (Model: KP-View 3D) and its predicate device, have the same indication for use, functions, physical characteristics, performance characteristics. They are equivalent in model name.

Substantial equivalence

The comparison between the overall specifications of the predicate device (Dental Cone-beam Computed Tomography, Model: iDT901X1)) and the subject device (Dental Cone-beam Computed Tomography, Model: KP-View 3D)) is shown in Table 1. Any difference between the predicate device and the subject device have no impact on safety of the subject device and do not raise any new potential or increased safety risks.

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

	Subject DeviceDental Cone-beamComputed Tomography(Model: KP-View 3D )(K240855)	Predicate DeviceDental Cone-beamComputed Tomography(Model:iDT901X1 )(K232710)
Model	KP-View 3D	iDT901X1
Trade Name	Dental Cone-beamComputed Tomography	/
Product Code	OAS	OAS
RegulationNumber	21 CFR 892.1750	21 CFR 892.1750
Regulation Name	OAS: Computedtomography x-raysystem	OAS: Computedtomography x-raysystem
DeviceClassificationName	X-Ray, Tomography,Computed, Dental	X-Ray, Tomography,Computed, Dental
Indications foruse	KP-View 3D is intendedto producetwo-dimensional digitalx-ray images includingpanoramic andcephalometric image, andthree-dimensional digitalx-ray images of the dental,oral, maxillofacial region,at the direction ofhealthcare professionals asdiagnostic support foradult and pediatricpatients.This device is not intendedfor use on patients lessthan approximately 21 kg(46 lb) in weight and 113cm (44.5 in) in height;	Dental Cone-beamComputed Tomographyis intended to producetwo-dimensional digitalx-ray images includingpanoramic andcephalometric image, andthree-dimensional digitalx-ray images of thedental, oral, maxillofacialregion, at the direction ofhealthcare professionalsas diagnostic support foradult and pediatricpatients.This device is notintended for use onpatients less thanapproximately 21 kg (46lb) in weight and 113 cm
	Subject Device	Predicate Device
	Dental Cone-beamComputed Tomography(Model: KP-View 3D )(K240855)	Dental Cone-beamComputed Tomography(Model:iDT901X1)(K232710)
	measurementsapproximately correspondto that of an average 5 yearold.	(44.5 in) in height; theseheight and weightmeasurementsapproximatelycorrespond to that of anaverage 5 year old.
Target Population	For patients 6 years andolder	For patients 6 years andolder
Anatomical Site	The dental, oral,maxillofacial region	The dental, oral,maxillofacial region
Users	Health care professionals	Health care professionals
Patient ContactMaterial	Meet ISO 10993 seriesstandard	Meet ISO 10993 seriesstandard
Sterility	Non-sterile	Non-sterile
TubeVoltage	60kV~120kV	60kV~120kV
TubeCurrent	1 mA~20 mA	1 mA~20 mA
Nominal FocalSpot Size	0.5	0.5
PulseExposurefunction	Yes	Yes
Power	Frequency: 50/60HzVoltage: 110-120VACPower: 3.0KVA	Frequency: 50/60HzVoltage: 110-120VACPower: 3.0KVA
Detectormaterial	FPD (TFT)CsI	FPD (TFT)CsI
Pixel Size	200μm x 200μm (Withbinning) (CT,Cephalometric)	200μm x 200μm (Withbinning) (CT,Cephalometric)
	Subject Device	Predicate Device
	Dental Cone-beamComputed Tomography(Model: KP-View 3D )(K240855)	Dental Cone-beamComputed Tomography(Model:iDT901X1 )(K232710)
PixelNumber	100µm x 100µm (Withoutbinning) (CT, Panoramic)15041248(With binning)(CT, Cephalometric)8002496(Withoutbinning) (CT)300865(Without binning)(Panoramic)15041248(With binning)(Cephalometric)	100µm x 100µm(Without binning) (CT,Panoramic)15041248(Withbinning) (CT,Cephalometric)8002496(Withoutbinning) (CT)300865(Withoutbinning) (Panoramic)15041248(Withbinning) (Cephalometric)
Size ofAreaReceivingX-ray	300.8mm x 249.6mm (CT,CEPH)80mm x 249.6mm (CT)300.8mm x 6.5mm(PANO)	300.8mm x 249.6mm(CT, CEPH)80mm x 249.6mm (CT)300.8mm x 6.5mm(PANO)
spatial resolution	5lp/mm	5lp/mm
Number ofBits	16bits	16bits
SID/SOD	SID: 750mm/490mm	SID: 750mm/490mm
Dimension(WxDxH)	Max.overall dimension1300mm1272mm2365mm	Max.overall dimension1300mm1272mm2365mm
Weight	233kg±5kg	233kg±5kg
	Subject DeviceDental Cone-beamComputed Tomography(Model: KP-View 3D )(K240855)	Predicate DeviceDental Cone-beamComputed Tomography(Model:iDT901X1)(K232710)
Imaging Mode	CBCT, PANO, CEPH	CBCT, PANO, CEPH
Panoramic ScanPerformance (Scan Time)	15sec	15sec
CephalometricRadiography (Scan Time)	2.3sec	2.3sec
CT Scan Time	22sec	22sec
CT FOV(Voxel Size)	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 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)
Software functions	-image acquisition-data management-image display-image processing-System Settings	-image acquisition-data management-image display-image processing-System Settings
Software level ofdocumentation	Basic Level	Basic Level
Applied Standards
	Subject DeviceDental Cone-beamComputed Tomography(Model: KP-View 3D )(K240855)	Predicate DeviceDental Cone-beamComputed Tomography(Model:iDT901X1)(K232710)
Electrical SafetyStandard	ANSI/AAMI ES60601-1IEC 60601-1	ANSI/AAMI ES60601-1IEC 60601-1-2
ElectromagneticCompatibilityStandard	IEC 60601-1-2	IEC 60601-1-2
Radiation SafetyStandard	IEC 60601-1-3	IEC 60601-1-3
ElectricalEquipmentUsability Safety	IEC 60601-1-6	IEC 60601-1-6
UsabilityEngineeringStandard	IEC 62366	IEC 62366
Software LifecycleProcess Standard	IEC 62304	IEC 62304
Essentialperformance ofdental extra-oral XrayequipmentStandard	IEC 60601-2-63	IEC 60601-2-63
Acceptance tests ofImagingperformanceof computed	IEC 61223-3-4IEC 61223-3-7	IEC 61223-3-4IEC 61223-3-7
	Subject Device	Predicate Device
	DentalCone-beam	Dental Cone-beam
	ComputedTomography	Computed Tomography
	(Model: KP-View 3D )	(Model:iDT901X1 )
	(K240855)	(K232710)
equipment
Standard

SafetyLaser	IEC 60825-1	IEC 60825-1
standard
Risk Management	ISO 14971	ISO 14971
Standard

DICOM Standard	ISO 12052:2017	ISO 12052:2017

Biocompatibility	ISO 10993-1	ISO 10993-1
Standard	ISO 10993-5	ISO 10993-5
Compliance	ISO 10993-10	ISO 10993-10
	ISO 10993-23	ISO 10993-23

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Image /page/10/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 a simple sans-serif font.

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Image /page/11/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 a simple sans-serif font.

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Image /page/12/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 a simple sans-serif font.

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Image /page/13/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 both Chinese characters and English. The English text reads "YIAN MEDICAL" in gray.

	Table	1
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The subject device and the predicate device are equivalent in the model name, same in the indications for use, patient population, use environment, software functions, and software level of documentation, performance characteristics and 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 previous submission is valid for the subject device of this submission and 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

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·IEC 60601-2-63 Edition 1.2 2017-07

Bench Testing Summary

The modifications of the device have no impact on the product's design, working principle, software function, software documentation level, performance characteristic and technical specification indication for use, patient population, environment of use, user needs, thus no impact on the previously conducted Bench Testing and validation. No new bench testing or validation was needed.

The previously conducted and submitted verification and validation test results are still valid for the modified device and is in compliance with the above standards, regulations and performance standards. 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 of this premarket submission, did not require clinical studies to support substantial equivalence.

Conclusion:

The conclusions drawn from the nonclinical tests demonstrate that the subject device, Dental Cone-beam Computed Tomography (Model: KP-View 3D) 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.