(126 days)
Not Found
No
The document describes standard image processing and clinical evaluation by a radiologist, with no mention of AI, ML, or related concepts like training/test sets for algorithmic performance.
No.
The device is intended to produce images for diagnostic support, not for treating diseases or conditions.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is intended to produce images "as diagnostic support for adult and pediatric patients." Additionally, the 'Device Description' 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 an Image processing system (which includes software). 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 Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a Dental Cone-beam Computed Tomography system that produces X-ray images of the dental, oral, and maxillofacial region. It works by using X-rays to create images of the internal structures of the body.
- No Specimen Analysis: There is no mention of the device analyzing any biological specimens. Its function is based on capturing and processing images generated by X-ray radiation passing through the patient's body.
Therefore, this device falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Dental Cone-beam Computed Tomography (Model:iDT901X1) is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, at the direction of healthcare professionals as diagnostic support for adult and pediatric patients.
This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height; these height and weight measurements approximately correspond to that of an average 5 year old.
Product codes (comma separated list FDA assigned to the subject device)
OAS
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).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray (Cone-beam Computed Tomography, Panoramic Radiography, Cephalometric Radiography)
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.
Children aged 6 (except infants) to elderly
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical evaluation.
Sample Size: Not specified beyond "a number of sample scans and diagnostic images".
Key Results: The overall image quality was acceptable for all cases and image types in various scanning mode for both adult and pediatric.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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 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)
Dental Cone-beam Computed Tomography (Model:iDT901X1) is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, at the direction of healthcare professionals as diagnostic support for adult and pediatric patients.
This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height; these height and weight measurements approximately correspond to that of an average 5 year old.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ 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, followed by the Chinese characters for "Yian Medical" in gray. Below the Chinese characters is the English text "YIAN MEDICAL" in gray.
510(k) Summary K232710
| Date Prepared: | Jun 30, 2023 |
|---|---|
| Manufacturer: | Yian Medical Technology (Haining) Co., Ltd |
| 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: | / |
|---|---|
| Device Name: | Dental Cone-beam Computed Tomography |
| Classification Name: | Computed tomography x-ray system |
| Regulatory Number: | 21 CFR Part 892.1750 |
| Product Code: | OAS |
| Device Class: | Class II |
| Review Panel: | Radiology |
Identification of the Legally Marketed Predicate Device:
| Trade Name: | PreXion3D Explorer PRO, Model P03B |
|---|---|
| Classification Name: | Computed tomography x-ray system |
| Regulatory Number: | 21 CFR Part 892.1750 |
| Product Code: | OAS |
| Device Class: | Class II |
| Review Panel: | Radiology |
| Submitter/510(k) Holder: | PreXion Corporation |
| Clearance: | K221525 (cleared July 22, 2022) |
Device Description:
( Product Name: Dental Cone-beam Computed Tomography, The product Model:iDT901X1) uses cone-beam computed tomography (CBCT) through X-ray cone-beam, panoramic radiography, cephalometric radiography to produce images of
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:
Dental Cone-beam Computed Tomography (Model:iDT901X1) is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, at the direction of healthcare professionals as diagnostic support for adult and pediatric patients.
This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height; these height and weight measurements approximately correspond to that of an average 5 year old.
Standards:
- A IEC60601-1 Edition 3.2 2020-08 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
-
ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]
- IEC 60601-1-2 Edition 4.1 2020-09 Medical electrical equipment Part 1-2: A General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC /TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment Part > 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
-
IEC 60601-1-3 Edition 2.2 2021-01 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
-
IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
-
IEC 62366-1 Edition 1.1 2020-06 Medical devices Part 1: Application of usability engineering to medical devices, including Amendment 1
-
IEC 60601-2-63 Edition 1.1 2017-07 CONSOLIDATED VERSION Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
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 Computed | ||
| Tomography | ||
| (Model:iDT901X1 ) | P03B (K221525) | |
| Manufacturer | Yian Medical Technology | |
| (Haining) Co., Ltd. | PreXion Corporation | |
| Trade Name | / | PreXion3D Explorer |
| PRO | ||
| Product Code | OAS | OAS |
| Regulation | 21 CFR 892.1750 | 21 CFR 892.1750 |
| Subject Device | Predicate Device | |
| Dental Cone-beam Computed | ||
| Tomography | ||
| (Model:iDT901X1) | P03B (K221525) | |
| Number | ||
| 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 | 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. | PreXion3D Explorer PRO 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, ENT (Ear, Nose and
Throat) and neck region at the
direction of healthcare
professionals as diagnostic
support for adult and pediatric
patients. Cephalometric
imaging also includes the
hand and wrist to obtain
carpus images for growth and
maturity assessment.
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. |
| | Subject Device | Predicate Device |
| | Dental Cone-beam Computed
Tomography
(Model:iDT901X1) | P03B (K221525) |
| Target Population | Children aged 6 (except
infants) to elderly | Children aged 6 (except
infants) to elderly |
| Anatomical Site | The dental, oral,
maxillofacial region | The dental, oral,
maxillofacial region
ENT (Ear, Nose and Throat)
and neck 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 | 90-110KV |20 mA | 1-5.3mA |
| Tube
Current | 1 mA
| Focal Spot
Size | 0.5 | 0.3mm x 0.3mm |
| Pulse
Exposure
function | Yes | Yes |
| Power | Frequency: 50/60Hz
Voltage: 110-120VAC
Power: 3.0kVA | Frequency: 50/60Hz
Voltage: 110-240VAC
Power: 1.0KVA |
| Detector
material | FPD (TFT)
CsI | FPD (TFT)
CsI:Tl / Gd2 O2 S:Tb |
| Pixel Size | 200μm x 200μm (With binning)
(CT, Cephalometric)
100μm x 100μm ( Without
binning ) (CT, Panoramic) | 248 μm x248µm (With
binning)
(CT, CT-Panoramic,
Panoramic)
124 µm x124µm
(Without binning)
(CT, CT-Panoramic,
Panoramic, Ceph) |
| Pixel
Number | 15041248(With binning) (CT,
Cephalometric) | 1024x1280(With
binning)
(CT, CT-Panoramic) |
| | Subject Device | Predicate Device |
| | Dental Cone-beam Computed
Tomography
(Model:iDT901X1) | P03B (K221525) |
| | 8002496(Without
binning)
(CT) | 2560x2048 (Without
binning)
(CT, CT-Panoramic,
Ceph) |
| | 300865(Without
binning)
(Panoramic) | 1900 x 120
(Panoramic) |
| | 15041248(With
binning)
(Cephalometric) | 2560 x 2048
(Cephalometric) |
| Size of
Area
Receiving
X-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 of
Bits | 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 x
2330 mm (CT, CTPanoramic,
Panoramic)
1164 mm x 1690 mm x
2330 mm (with Ceph) |
| Weight | 233kg±5kg | 230 kg (CT, CTPanoramic,
Panoramic, Ceph) |
| Imaging Mode | CBCT, PANO, CEPH | CT scan, CT-Panoramic,
Panoramic scan,
Cephalometric
radiography |
| | Subject Device
Dental Cone-beam Computed
Tomography
(Model:iDT901X1) | Predicate Device
P03B (K221525) |
| Panoramic Scan
Performance (Scan
Time) | 15sec | 8-16sec |
| Cephalometric
Radiography (Scan
Time) | 2.3sec | 0.16sec |
| CT Scan Time | 22s | 10-20sec |
| 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 150mm x
H156mm (0.100 -
0.200mm)
Diameter 150mm x
H100mm (0.100 -
0.200mm)
Diameter 100mm x
H100mm (0.100 -
0.200mm)
Diameter 50mm x
H50mm (0.100 - 0.200mm) |
| Software functions | -image acquisition
-data management
-image display
-image processing
-System Settings | -Image acquisition
-Data management
-Display High-resolution 2D
and 3D Images Function
-Image Processing Function
includes Airway measurement
-system setting |
| Software level of
documentation | Basic Documentation Level | Basic Documentation Level |
| | Subject Device
Dental Cone-beam Computed
Tomography
(Model:iDT901X1) | Predicate Device
P03B (K221525) |
| Electrical Safety
Standard | ANSI/AAMI ES60601-1 | ANSI/AAMI ES60601-1 |
| 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 62366 | IEC 60601-1-6
IEC 62366 |
| Usability
Engineering
Standard | IEC 62304 | IEC 62304 |
| Software Lifecycle
Process Standard
Essential
performance of
dental extra-oral
Xray
equipment
Standard | IEC 60601-2-63 | IEC 60601-2-63 |
| Acceptance tests of
Imaging
performance
of dental X-ray
equipment
Standard | IEC 61223-3-4 | IEC 61223-3-4 |
| Acceptance tests of
Imaging
performance
of computed
tomography X-ray
equipment
Standard | IEC 61223-3-7 | IEC 61223-3-5 |
| Laser Safety | | |
| | Subject Device
Dental Cone-beam Computed
Tomography
(Model:iDT901X1) | Predicate Device
P03B (K221525) |
| Standard
Risk Management
Standard
DICOM Standard
Biocompatibility
Standard
Compliance | IEC 60825-1
ISO 14971
ISO 12052:2017
ISO 10993-1
ISO 10993-5
ISO 10993-10
ISO 10993-23 | IEC 60825-1
ISO 14971
NEMA PS 3.1 - 3.20
ISO 10993-1
ISO 10993-5
ISO 10993-10 |
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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.
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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.
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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.
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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.
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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.
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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
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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.