(80 days)
Not Found
No
The document describes standard X-ray imaging and processing software without mentioning AI or ML capabilities. The focus is on hardware features, image transfer, and basic image processing and viewing.
No
Explanation: This device is an X-ray Flat Panel Detector, which is used to capture radiographic images. It does not provide any therapy or treatment, but rather aids in diagnosis by generating images for a radiologist to interpret.
Yes
Explanation: The Yushan X-Ray Flat Panel Detector captures radiographic images of human anatomy for display, which are then used by radiologists for examination. The accompanying software (Xresta) includes an "Image viewer and measurement" function, allowing radiologists to interpret the captured images to aid in diagnosis. While the device itself is an imaging device, its intended use within the clinical workflow facilitates diagnostic processes.
No
The device description clearly states that the device is a "Yushan X-Ray Flat Panel Detector," which is a hardware component (a portable/non-portable detector). While it includes software components (Xresta and DR Console), the core device is a physical detector.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "capture for display radiographic images of human anatomy." This is a medical imaging device used for diagnostic purposes in vivo (within the living body), not in vitro (outside the body, typically on biological samples).
- Device Description: The description details an X-ray flat panel detector used in conjunction with software for general radiography exams. This aligns with medical imaging, not IVD testing.
- Input Imaging Modality: The input is X-Ray, which is a medical imaging modality, not a method used in IVD testing.
- Anatomical Site: The device is used on "human anatomy," indicating direct interaction with the patient's body for imaging.
- Performance Studies: The performance studies focus on non-clinical data related to electrical safety, software, cybersecurity, mechanical properties, and image quality evaluation compared to a predicate device. These are typical evaluations for medical imaging devices, not IVDs which would involve analytical and clinical performance studies on biological samples.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device directly images the human body using X-rays.
N/A
Intended Use / Indications for Use
The Wireless (V14C, V14G, F14C, F14G, V17C, V17G)/Wired (V14C, V14G, F14C, F14G, V17C, V17G, V17Ge, V17Ce) Yushan X-Ray Flat Panel Detector is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The Yushan X-Ray Flat Panel Detector is not intended for mammography, fluoroscopy, tomography, and angiography applications. The use of this product is not recommended for pregnant women and the risk of radioactivity must be evaluated by a physician.
Product codes (comma separated list FDA assigned to the subject device)
MOB, MQB
Device Description
The subject device Yushan X-Ray Flat Panel Detector, model V14C, V14G, V17C, V17G, F14C, F14G are portable(wireless/wired) detectors, while V17Ce, V17Ge are a non-portable(wired) detector. The Yushan X-Ray Flat Panel Detector is designed to be used in any environment that would typically use a radiographic cassette for examinations. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid or free cassette exams. Additionally, rounded-edge design for easy handling, image compression algorithm for faster image transfer, LED design for easy detector identification, extra protection against ingress of water.
Yushan series is working by using Xresta and DR console.
The Xresta is a software running on a Windows PC as an user interface for radiologist to perform a general radiography exam. The function includes:
-
- Detector status update
-
- Xray exposure workflow
-
- Image viewer and measurement.
-
- Post image process and DICOM file I/O
-
- Image database: DROC support the necessary DICOM Services to allow a smooth integration into the clinical network
The software level of concern is determined to be basic based on the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
The cybersecurity risks have also been addressed to assure that no new or increased cybersecurity risks were introduced as a part of device risk analysis. These risks are defined as sequence of events leading to a hazardous situation, and the controls for these risks were treated and implemented as proposed in the risk analysis (e.g., requirements, verification).
The DR Console is a software/app-based device, which is a software itself. When this app is operating the OTS can be considered as the iOS system (iOS 16 or above), the safety and effectiveness of this OTS has been assessed and evaluated through the software testing (compatibility) action and also the usability test (summative evaluation). All the functions operate normally and successfully under this OTS framework.
The function includes:
-
- Imaging procedure review
-
- Worklist settings
-
- Detector connection settings
-
- Calibration
-
- Image processing
Both software level of concern is determined to be basic based on the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; and the cybersecurity risks have also been addressed to assure that no new or increased cybersecurity risks were introduced as a part of device risk analysis. These risks are defined as sequence of events leading to a hazardous situation, and the controls for these risks were treated and implemented as proposed in the risk analysis (e.g., requirements, verification).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found (Usage not recommended for pregnant women)
Intended User / Care Setting
Not Found (Implied: radiologist, in a general radiography exam setting)
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)
Non-clinical Performance Data: Yushan X-Ray Flat Panel Detector confirms to the voluntary standards such as AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 60601-1-6, ANSI AAMI IEC 62366-1 and ANSI/AAMI HE75. In addition, the FDA's Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices (issued on September 1, 2016) was followed to describe the detector characteristics; Content of Premarket Submissions for Device Software Functions (issued on June 14, 2023) was followed to evaluate the level of concern as basic; Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (issued on September 27, 2023) was also followed to consider issues related to cybersecurity in the design and development process of this device. Additionally, the risk analysis, necessary verification and validation activities were performed. Load-bearing characteristics and protection against ingress of water were tested and passed. The internal circuit design was demonstrated through EMC emission testing: IEC60601-1-2 and the results were satisfactory. Biocompatibilities were demonstrated through ISO 10993 series to prove the using material safe and effective. Furthermore, the image quality evaluation confirmed that the image quality of the Yushan X-Ray Flat Panel Detector is substantially equivalent to that of the predicate device.
Clinical Performance Data: No clinical study has been performed. The substantial equivalence has been demonstrated by non-clinical studies.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 19, 2024
InnoCare Optoelectronics Corp. % April Cheng Regulatory Affairs Rm. B, No. 2, Sec. 2, Huanxi Rd., Southern Taiwan Science Park, Xinshi Dist. Tainan City, 741 TAIWAN
Re: K243171
Trade/Device Name: Yushan X-Ray Flat Panel Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MOB Dated: September 26, 2024 Received: November 4, 2024
Dear April Cheng:
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.
1
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).
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 medical devices and radiation-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.
2
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
Enclosure
3
Indications for Use
510(k) Number (if known) K243171
Device Name Yushan x-ray flat panel detector
Indications for Use (Describe)
The Wireless (V14C, V14G, F14G, V17C, V17G)/Wired (V14C, V14G, F14C, F14G, V17C, V17G, V17Ge, V17Ce) Yushan X-Ray Flat Panel Detector is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The Yushan X-Ray Flat Panel Detector is not intended for mammography, fluoroscopy, tomography, and angiography applications. The use of this product is not recommended for pregnant women and the risk of radioactivity must be evaluated by a physician.
| 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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4
510(k) Summary K243171
I. SUBMITTER
InnoCare Optoelectronics Corp. Rm. B. No. 2, Sec. 2, Huanxi Rd., Southern Taiwan Science Park, Xinshi Dist., Tainan City 741, Taiwan, R.O.C. TEL: +886-6-700-7238 # 22598 Email: yumei.cheng@innocare-x.com Contact Person: Yumei Cheng / Regulatory affairs Date Prepared: Feb 10, 2022
II. DEVICE
Trade name: Yushan X-Ray Flat Panel Detector Model name: V14C, V14G, V17C, V17G, F14C, F14G, V17Ce, V17Ce, V17Ge Regulation description: Stationary x-ray system. Review panel: Radiology Product code: MQB Regulation number: 21 CFR 892.1680 Device class: Class II
III. PREDICATE DEVICE
Substantial equivalence to the following predicate device is as follows: a. Trade/Device Name: Yushan X-Ray Flat Panel Detector with DROC FDA 510(k) clearance number: K201528 Manufacturer: InnoCare Optoelectronics Corp. Regulation description: Stationary x-ray system. Review panel: Radiology Product code: MQB Regulation number: 21 CFR 892.1680
5
Device class: Class
b. Trade/Device Name: Yushan X-Ray Flat Panel Detector with DROC FDA 510(k) clearance number: K210988 Manufacturer: InnoCare Optoelectronics Corp. Regulation description: Stationary x-ray system. Review panel: Radiology Product code: MQB Regulation number: 21 CFR 892.1680 C. Trade/Device Name: Yushan X-Ray Flat Panel Detector with DROC FDA 510(k) clearance number: K220510 Manufacturer: InnoCare Optoelectronics Corp. Regulation description: Stationary x-ray system. Review panel: Radiology Product code: MQB Regulation number: 21 CFR 892.1680
IV. INDICATIONS FOR USE
The Wireless (V14C, V14G, F14C, F14G, V17C, V17G)/Wired (V14C, V14G, F14C, F14G, V17C, V17G, V17Ge, V17Ce) Yushan X-Ray Flat Panel Detector is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The Yushan X-Ray Flat Panel Detector is not intended for mammography, fluoroscopy, tomography, and angiography applications. The use of this product is not recommended for pregnant women and the risk of radioactivity must be evaluated by a physician.
6
V. DESCRIPTION OF THE DEVICE SUBJECT TO PREMERKET NOTIFI-CATION
The subject device Yushan X-Ray Flat Panel Detector, model V14C, V14G, V17C, V17G, F14C, F14G are portable(wireless/wired) detectors, while V17Ce, V17Ge are a non-portable(wired) detector. The Yushan X-Ray Flat Panel Detector is designed to be used in any environment that would typically use a radiographic cassette for examinations. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid or free cassette exams. Additionally, rounded-edge design for easy handling, image compression algorithm for faster image transfer, LED design for easy detector identification, extra protection against ingress of water.
Yushan series is working by using Xresta and DR console.
The Xresta is a software running on a Windows PC as an user interface for radiologist to perform a general radiography exam. The function includes:
-
- Detector status update
-
- Xray exposure workflow
-
- Image viewer and measurement.
-
- Post image process and DICOM file I/O
-
- Image database: DROC support the necessary DICOM Services to allow a smooth integration into the clinical network
The software level of concern is determined to be basic based on the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
The cybersecurity risks have also been addressed to assure that no new or increased cybersecurity risks were introduced as a part of device risk analysis. These risks are defined as sequence of events leading to a hazardous situation, and the controls for these risks were treated and implemented as proposed in the risk analysis (e.g., requirements, verification).
The DR Console is a software/app-based device, which is a software itself. When this app is operating the OTS can be considered as the iOS system (iOS 16 or above), the
7
safety and effectiveness of this OTS has been assessed and evaluated through the software testing (compatibility) action and also the usability test (summative evaluation). All the functions operate normally and successfully under this OTS framework.
The function includes:
-
- Imaging procedure review
-
- Worklist settings
-
- Detector connection settings
-
- Calibration
-
- Image processing
Both software level of concern is determined to be basic based on the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; and the cybersecurity risks have also been addressed to assure that no new or increased cybersecurity risks were introduced as a part of device risk analysis. These risks are defined as sequence of events leading to a hazardous situation, and the controls for these risks were treated and implemented as proposed in the risk analysis (e.g., requirements, verification).
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Yushan X-Ray Flat Panel Detector (model: V14C, V14G, F14C, F14G, V17C, V17G, V17Ge, V17Ce) has the same Indications for Use, and very similar functional and technical requirements as the model V14C, V14G, V17G, V17G, V17Ge in K201528, F14C, F14G in K210988, V17Ce in K201528. The comparison of technological characteristics are listed in the following table. Yushan X-Ray Flat Panel Detector has been successfully tested and validated.
8
| Product name | Yushan X-Ray Flat Panel
Detector | Yushan X-Ray Flat Panel
Detector with DROC | Yushan X-Ray Flat Panel
Detector with DROC | Yushan X-Ray Flat Panel
Detector with DROC |
|--------------|-------------------------------------|-----------------------------------------------|-----------------------------------------------|-----------------------------------------------|
| Model name | V14C | V14C | - | - |
| | V14G | V14G | - | - |
| | V17C | V17C | - | - |
| | V17G | V17G | - | - |
| | V17Ge | V17Ge | - | - |
| | F14C | - | F14C | - |
| | F14G | - | F14G | - |
| | V17Ce | - | - | V17Ce |
| Manufacturer | InnoCare Optoelectronics
Corp. | InnoCare Optoelectronics
Corp. | InnoCare Optoelectronics
Corp. | InnoCare Optoelectronics
Corp. |
| | Qualified
number | (Subject Device) | K201528 | K210988 |
| Clinical | | | | |
9
| Indications for Use | Pixel Pitch | 140 μm | 140 μm | 140 μm | 140 μm | ||||
|---|---|---|---|---|---|---|---|---|---|
| The Wireless (V14C, V14G, | |||||||||
| F14C, F14G, V17C, | |||||||||
| V17G)/Wired (V14C, V14G, | |||||||||
| F14C, F14G, V17C, V17G, | |||||||||
| V17Ge, V17Ce) Yushan X- | |||||||||
| Ray Flat Panel Detector is in- | |||||||||
| tended to capture for display | |||||||||
| radiographic images of hu- | |||||||||
| man anatomy. It is intended | |||||||||
| for use in general projection | |||||||||
| radiographic applications | |||||||||
| wherever conventional | |||||||||
| film/screen or CR systems | |||||||||
| may be used. The Yushan X- | |||||||||
| Ray Flat Panel Detector is | |||||||||
| not intended for mammogra- | |||||||||
| phy, fluoroscopy, tomogra- | |||||||||
| phy, and angiography appli- | |||||||||
| cations. The use of this prod- | |||||||||
| uct is not recommended for | The Wireless (V14C, V14G, | ||||||||
| V17C, V17G)/ Wired (V14C, | |||||||||
| V14G, V17C, V17G, | |||||||||
| V17Ge) Yushan X-Ray Flat | |||||||||
| Panel Detector with DROC is | |||||||||
| intended to capture for | |||||||||
| display radiographic images | |||||||||
| of human anatomy. It is in- | |||||||||
| tended for use in general pro- | |||||||||
| jection radiographic applica- | |||||||||
| tions wherever conventional | |||||||||
| film/screen or CR systems | |||||||||
| may be used. The Yushan X- | |||||||||
| Ray Flat Panel Detector with | |||||||||
| DROC is not intended for | |||||||||
| mammography, fluoroscopy, | |||||||||
| tomography, and angi- | |||||||||
| ography applications. | The Wireless/Wired Yushan | ||||||||
| X-Ray Flat Panel Detector | |||||||||
| with DROC is intended to | |||||||||
| capture for display radio- | |||||||||
| graphic images of human | |||||||||
| anatomy. It is intended for | |||||||||
| use in general | |||||||||
| projection radiographic ap- | |||||||||
| plications wherever conven- | |||||||||
| tional film/screen or CR sys- | |||||||||
| tems may be used. The | |||||||||
| Yushan X-Ray Flat Panel De- | |||||||||
| tector with DROC is not in- | |||||||||
| tended for mammography, | |||||||||
| fluoroscopy, tomography, | |||||||||
| and angiography applica- | |||||||||
| tions. | The Wired Yushan X-Ray | ||||||||
| Flat Panel Detector is in- | |||||||||
| tended to capture for display | |||||||||
| radiographic images of hu- | |||||||||
| man anatomy. It is intended | |||||||||
| for use in general projection | |||||||||
| radiographic applications | |||||||||
| wherever conventional | |||||||||
| film/screen or CR systems | |||||||||
| may be used. The Yushan X- | |||||||||
| Ray Flat Panel Detector is | |||||||||
| not intended for mammogra- | |||||||||
| phy, fluoroscopy, tomogra- | |||||||||
| phy, and angiography | |||||||||
| applications. The use of this | |||||||||
| product is not recommended | |||||||||
| for pregnant women and the | |||||||||
| risk of | |||||||||
| radioactivity must be evalu- | |||||||||
| ated by a physician. | DQE | V series: | |||||||
| GOS: at 1 lp/mm, RQA5 is | |||||||||
| 0.27 | |||||||||
| CsI: at 1 lp/mm, RQA5 is | |||||||||
| 0.48 | |||||||||
| F series: | |||||||||
| GOS: at 1 lp/mm, RQA5 is | |||||||||
| 0.27 | |||||||||
| CsI: at 1 lp/mm, RQA5 is | |||||||||
| 0.50 | GOS: at 1 lp/mm, RQA5 is | ||||||||
| 0.27 | |||||||||
| CsI: at 1 lp/mm, RQA5 is | |||||||||
| 0.48 | GOS: at 1 lp/mm, RQA5 is | ||||||||
| 0.27 | |||||||||
| CsI: at 1 lp/mm, RQA5 is | |||||||||
| 0.50 | CsI: at 1 lp/mm, RQA5 is | ||||||||
| 0.48 | |||||||||
| Technical | pregnant women and the risk | ||||||||
| of radioactivity must be eval- | |||||||||
| uated by a physician. | MTF | ||||||||
| Max. | |||||||||
| resolution | CsI: at 1 lp/mm, RQA5 is | ||||||||
| 0.64 |
GOS: 3.57 lp/mm
CsI: 3.57 lp/mm | GOS: at 1 lp/mm, RQA5 is
0.52
CsI: at 1 lp/mm, RQA5 is
0.69
GOS: 3.57 lp/mm
CsI: 3.57 lp/mm | GOS: at 1 lp/mm, RQA5 is
0.52
CsI: at 1 lp/mm, RQA5 is
0.63
GOS: 3.57 lp/mm
CsI: 3.57 lp/mm | CsI: at 1 lp/mm, RQA5 is
0.69
CsI: 3.57 lp/mm | |
| Dimensions
(mm) | V14G:
460(W)×383(L)×15(H)
V14C:
460(W)×383(L)×15(H)
V17G:
460(W)×460(L)×15(H)
V17C:
460(W)×460(L)×15(H)
V17Ge:
460(W)×460(L)×15(H)
F14G:
460(W)×383(L)×15(H)
F14C:
460(W)×383(L)×15(H)
V17Ce:
460(W)×460(L)×15(H) | V14G:
460(W)×383(L)×15(H)
V14C:
460(W)×383(L)×15(H)
V17G:
460(W)×460(L)×15(H)
V17C:
460(W)×460(L)×15(H)
V17Ge:
460(W)×460(L)×15(H) | F14G:
460(W)×383(L)×15(H)
F14C:
460(W)×383(L)×15(H) | V17Ce:
460(W)×460(L)×15(H) | A/D Conversion | 16 bit | 16 bit | 16 bit | 16 bit |
| Weight (Kg) | V14G: 2.7
V14C: 2.7
V17G: 3.2
V17C: 3.2
V17Ge: 3.5
F14G: 2.3
F14C: 2.5
V17Ce: 3.6 | V14G: 2.7
V14C: 2.7
V17G: 3.2
V17C: 3.2
V17Ge: 3.5 | F14G: 2.3
F14C: 2.5 | V17Ce: 3.6 | | | | | |
| Substrate | Glass: For V series
Non-Glass
(polyethylene terephthalate
laminate): For F series | Glass | Non-Glass
(polyethylene terephthalate
laminate) | Glass | | | | | |
| Scintillator | V14G: GOS
V14C: CsI
V17G: GOS
V17C: CsI
V17Ge: GOS
F14G: GOS
F14C: CsI
V17Ce: CsI | V14G: GOS
V14C: CsI
V17G: GOS
V17C: CsI
V17Ge: GOS | F14G: GOS
F14C: CsI | V17Ce: CsI | | | | | |
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| Pixels | V14G: 2500 x 3052
V14C: 2500 x 3052
V17G: 3072 x 3072
V17C: 3072 x 3072
V17Ge: 3072 x 3072
F14G: 2500 x 3052
F14C: 2500 x 3052
V17Ce: 3072 x 3072 | V14G: 2500 x 3052
V14C: 2500 x 3052
V17G: 3072 x 3072
V17C: 3072 x 3072
V17Ge: 3072 x 3072 | F14G: 2500 x 3052
F14C: 2500 x 3052 | V17Ce: 3072 x 3072 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Interface | Wired: Gigabit Ethernet
(100BASE-TX or
10BASE-T)
Wireless: IEEE802.11 ac
/a/g/n
- V17Ge, V17Ce is not ap-
plicable for wireless func-
tion. | Wired: Gigabit Ethernet
(100BASE-TX or
10BASE-T)
Wireless: IEEE802.11 ac
/a/g/n - V17Ge is not applicable
for wireless function. | Wired: Gigabit Ethernet
(100BASE-TX or
10BASE-T)
Wireless: IEEE802.11 ac
/a/g/n | Not applicable |
| Power Source | Rechargeable Lithium
Battery - V17Ge, V17Ce is not
applicable for wireless
function. | Rechargeable Lithium
Battery
*not applicable on model
V17Ge | Rechargeable Lithium
Battery | Rechargeable Lithium
Battery
*not applicable on model
V17Ge |
| Biological | | | | |
| Biological
safety | All material contact with
patients are in accordance
with ISO 10993. | All material contact with
patients are in accordance
with ISO 10993. | All material contact with
patients are in accordance
with ISO 10993. | All material contact with
patients are in accordance
with ISO 10993. |
| Others | | | | |
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| Accessories | ||||||||
|---|---|---|---|---|---|---|---|---|
| - | Battery (Optional) | - | Battery (Optional)* | |||||
| V17Ge is not appli-cable | - | Battery (Optional) | - | Power supply | ||||
| (Adapter) | ||||||||
| - | Power supply | |||||||
| (Adapter) | - | Power supply | ||||||
| (Adapter) | - | Power supply | ||||||
| (Adapter) | - | SE cable (Back-up | ||||||
| cable) | ||||||||
| - | SE cable (Back-up | |||||||
| cable) | - | SE cable (Back-up | ||||||
| cable) | - | SE cable (Back-up | ||||||
| cable) | - | Power Cord | ||||||
| - | Power Cord | - | Power Cord | - | Power Cord (Optional) | |||
| - | Xresta Dongle (Optional) | - | Charger (Optional) | |||||
| - | DR Console (Optional) | - | Charger Adapter (Optional) | |||||
| - | DROC Dongle (Optional) |
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Non-clinical Performance Data: Yushan X-Ray Flat Panel Detector confirms to the voluntary standards such as AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 60601-1-6, ANSI AAMI IEC 62366-1 and ANSI/AAMI HE75. In addition, the FDA's Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices (issued on September 1, 2016) was followed to describe the detector characteristics; Content of Premarket Submissions for Device Software Functions (issued on June 14, 2023) was followed to evaluate the level of concern as basic; Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (issued on September 27, 2023) was also followed to consider issues related to cybersecurity in the design and development process of this device. Additionally, the risk analysis, necessary verification and validation activities were performed. Load-bearing characteristics and protection against ingress of water were tested and passed. The internal circuit design was demonstrated through EMC emission testing: IEC60601-1-2 and the results were satisfactory. Biocompatibilities were demonstrated through ISO 10993 series to prove the using material safe and effective. Furthermore, the image quality evaluation confirmed that the image quality of the Yushan X-Ray Flat Panel Detector is substantially equivalent to that of the predicate device.
Clinical Performance Data: No clinical study has been performed. The substantial equivalence has been demonstrated by non-clinical studies.
VIII. CONCLUSIONS
Based upon the supporting data provided, we concluded the 2 newly user interface applicable to Yushan X-Ray Flat Panel Detector is as safe and effective, which do not raise additional safety and effectiveness issues.
Yushan X-Ray Flat Panel Detector is substantially equivalent to the predicate device in technical characteristics, design features, operating principles, functional and performance characteristics, and for the intended uses in the stated medical specialties. Yushan X-Ray Flat Panel Detector is designed to comply with applicable federal and
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international safety and performance standards.
Based upon the supporting data summarized above, we concluded the 2 newly user interface applicable to Yushan X-Ray Flat Panel Detector is as safe and effective as the legally marketed device Yushan X-Ray Flat Panel Detector (K201528, K210988, K220510), and do not raise different questions of safety and effectiveness.