(28 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the description of the device and testing focuses on standard imaging and safety compliance.
No
The device is described as an imaging system intended for diagnostic support, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device provides "diagnostic support." The "Device Description" also mentions that it "provides diagnostic details for the medical facilities."
No
The device description explicitly states that the product consists of hardware components including a Frame, X-ray generator, Image receptor, and Image processing system (including Computer, Monitor, and Software workstation). This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The KP-View 3D is an imaging device that uses X-rays to produce images of the dental, oral, and maxillofacial regions. It does not analyze samples taken from the body.
- Intended Use: The intended use is to provide diagnostic support through imaging, not through the analysis of biological samples.
Therefore, the KP-View 3D falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
OAS
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).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
The dental, oral, maxillofacial region
Indicated Patient Age Range
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.
For patients 6 years and older
Intended User / Care Setting
healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
•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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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 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).
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 Radiological 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) K240855
Device Name Dental Cone-beam Computed Tomography
Indications for Use (Describe)
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.
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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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 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., Ltd |
| 1st 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) |
5
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:
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).
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 device
iDT901X1 Dental Cone
Beam-computed Tomography
(K232710) | | Modified device
KP-View 3D Dental Cone
Beam-computed Tomography
(K240855) | |
|----------|---------------------------------------------------------------------------------|--|------------------------------------------------------------------------------------|--|
| Model | iDT901X1 | | KP-View 3D | |
| Labeling | Model Name: iDT901X1 | | Model name: KP-View 3D | |
Indications for Use:
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.
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)]
6
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
7
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 Device
Dental Cone-beam
Computed Tomography
(Model: KP-View 3D )
(K240855) | Predicate Device
Dental Cone-beam
Computed Tomography
(Model:iDT901X1 )
(K232710) |
|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model | KP-View 3D | iDT901X1 |
| Trade Name | Dental Cone-beam
Computed Tomography | / |
| Product Code | OAS | OAS |
| Regulation
Number | 21 CFR 892.1750 | 21 CFR 892.1750 |
| Regulation Name | OAS: Computed
tomography x-ray
system | OAS: Computed
tomography x-ray
system |
| Device
Classification
Name | X-Ray, Tomography,
Computed, Dental | X-Ray, Tomography,
Computed, Dental |
| Indications for
use | 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; | Dental Cone-beam
Computed Tomography
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 |
| | Subject Device | Predicate Device |
| | Dental Cone-beam
Computed Tomography
(Model: KP-View 3D )
(K240855) | Dental Cone-beam
Computed Tomography
(Model:iDT901X1)
(K232710) |
| | measurements
approximately correspond
to that of an average 5 year
old. | (44.5 in) in height; these
height and weight
measurements
approximately
correspond to that of an
average 5 year old. |
| Target Population | For patients 6 years and
older | For patients 6 years and
older |
| Anatomical Site | The dental, oral,
maxillofacial region | The dental, oral,
maxillofacial region |
| Users | Health care professionals | Health care professionals |
| Patient Contact
Material | Meet ISO 10993 series
standard | Meet ISO 10993 series
standard |
| Sterility | Non-sterile | Non-sterile |
| Tube
Voltage | 60kV120kV | 60kV120kV |
| Tube
Current | 1 mA20 mA | 1 mA20 mA |
| Nominal Focal
Spot Size | 0.5 | 0.5 |
| Pulse
Exposure
function | Yes | Yes |
| Power | Frequency: 50/60Hz
Voltage: 110-120VAC
Power: 3.0KVA | Frequency: 50/60Hz
Voltage: 110-120VAC
Power: 3.0KVA |
| Detector
material | FPD (TFT)
CsI | FPD (TFT)
CsI |
| Pixel Size | 200μm x 200μm (With
binning) (CT,
Cephalometric) | 200μm x 200μm (With
binning) (CT,
Cephalometric) |
| | Subject Device | Predicate Device |
| | Dental Cone-beam
Computed Tomography
(Model: KP-View 3D )
(K240855) | Dental Cone-beam
Computed Tomography
(Model:iDT901X1 )
(K232710) |
| Pixel
Number | 100µm x 100µm (Without
binning) (CT, Panoramic)
15041248(With binning)
(CT, Cephalometric)
8002496(Without
binning) (CT)
300865(Without binning)
(Panoramic)
15041248(With binning)
(Cephalometric) | 100µm x 100µm
(Without binning) (CT,
Panoramic)
15041248(With
binning) (CT,
Cephalometric)
8002496(Without
binning) (CT)
300865(Without
binning) (Panoramic)
15041248(With
binning) (Cephalometric) |
| Size of
Area
Receiving
X-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 of
Bits | 16bits | 16bits |
| SID/SOD | SID: 750mm/490mm | SID: 750mm/490mm |
| Dimension
(WxDxH) | Max.overall dimension
1300mm1272mm2365mm | Max.overall dimension
1300mm1272mm2365mm |
| Weight | 233kg±5kg | 233kg±5kg |
| | Subject Device
Dental Cone-beam
Computed Tomography
(Model: KP-View 3D )
(K240855) | Predicate Device
Dental Cone-beam
Computed Tomography
(Model:iDT901X1)
(K232710) |
| Imaging Mode | CBCT, PANO, CEPH | CBCT, PANO, CEPH |
| Panoramic Scan
Performance (Scan Time) | 15sec | 15sec |
| Cephalometric
Radiography (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 of
documentation | Basic Level | Basic Level |
| Applied Standards | | |
| | Subject Device
Dental Cone-beam
Computed Tomography
(Model: KP-View 3D )
(K240855) | Predicate Device
Dental Cone-beam
Computed Tomography
(Model:iDT901X1)
(K232710) |
| Electrical Safety
Standard | ANSI/AAMI ES60601-1
IEC 60601-1 | ANSI/AAMI ES60601-1
IEC 60601-1-2 |
| Electromagnetic
Compatibility
Standard | IEC 60601-1-2 | IEC 60601-1-2 |
| Radiation Safety
Standard | IEC 60601-1-3 | IEC 60601-1-3 |
| Electrical
Equipment
Usability Safety | IEC 60601-1-6 | IEC 60601-1-6 |
| Usability
Engineering
Standard | IEC 62366 | IEC 62366 |
| Software Lifecycle
Process Standard | IEC 62304 | IEC 62304 |
| Essential
performance of
dental extra-oral X
ray
equipment
Standard | IEC 60601-2-63 | IEC 60601-2-63 |
| Acceptance tests of
Imaging
performance
of computed | IEC 61223-3-4
IEC 61223-3-7 | IEC 61223-3-4
IEC 61223-3-7 |
| | Subject Device | Predicate Device |
| | Dental
Cone-beam | Dental Cone-beam |
| | Computed
Tomography | Computed Tomography |
| | (Model: KP-View 3D ) | (Model:iDT901X1 ) |
| | (K240855) | (K232710) |
| equipment | | |
| Standard | | |
| | | |
| Safety
Laser | 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/9/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".
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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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| Table | 1 | |
|---|---|---|
| -- | ------- | --- |
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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Image /page/14/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 word "MEDICAL" in a slightly smaller font size.
·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.