Yushan X-Ray Flat Panel Detector by InnoCare Optoelectronics Corp.

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.

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:

1. Detector status update
1. Xray exposure workflow
1. Image viewer and measurement.
1. Post image process and DICOM file I/O
1. Image database: DROC support the necessary DICOM Services to allow a smooth integration into the clinical network

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:

1. Imaging procedure review
1. Worklist settings
1. Detector connection settings
1. Calibration
1. Image processing

AI/ML Overview

The provided document is a 510(k) summary for the Yushan X-Ray Flat Panel Detector. It outlines the device's technical characteristics and compares it to predicate devices to establish substantial equivalence. However, it does not describe a clinical study that proves the device meets specific acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity for a particular condition).

Instead, the document focuses on non-clinical performance data to demonstrate substantial equivalence, primarily by showing that the device adheres to recognized voluntary standards and exhibits comparable physical and image quality characteristics to previously cleared devices.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria for diagnostic performance (e.g., a specific sensitivity or specificity target for a clinical task) and the device's performance against those criteria. It focuses on technical specifications and compliance with standards.

The closest to "acceptance criteria" are the technical specifications listed for the subject device and the predicate devices, implying that meeting or being comparable to these specifications is considered acceptable for substantial equivalence.

Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Subject Device)
Indications for Use	"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 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 with DROC is not intended for mammography, fluoroscopy, tomography, and angiography applications." (Similar for all predicates)	"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."
Pixel Pitch	140 μm	140 μm
DQE (at 1 lp/mm, RQA5)	GOS: 0.27, CsI: 0.48 (predicate K201528) / GOS: 0.27, CsI: 0.50 (predicate K210988) / CsI: 0.48 (predicate K220510)	V series: GOS: 0.27, CsI: 0.48; F series: GOS: 0.27, CsI: 0.50
MTF (at 1 lp/mm, RQA5)	GOS: 0.52, CsI: 0.69 (predicate K201528) / GOS: 0.52, CsI: 0.63 (predicate K210988) / CsI: 0.69 (predicate K220510)	CsI: 0.64 (V series); GOS: 0.52, CsI: 0.63 (F series)
Max. Resolution	3.57 lp/mm (for both GOS and CsI in predicates)	3.57 lp/mm (for both GOS and CsI in subject device)
A/D Conversion	16 bit	16 bit
Biological Safety	All material contact with patients are in accordance with ISO 10993.	All material contact with patients are in accordance with ISO 10993.
EMC Emission	Satisfactory results from IEC60601-1-2 testing (implied by non-clinical performance section)	Results were satisfactory as per IEC60601-1-2 testing.
Image Quality	Substantially equivalent to predicate device (implied by non-clinical performance section)	Confirmed to be substantially equivalent to that of the predicate device.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not applicable in the context of a clinical performance study. The document states: "No clinical study has been performed."
Data Provenance: Not applicable. The evaluation relies on non-clinical (laboratory/technical) testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no clinical study with expert ground truth was performed.

4. Adjudication method for the test set

Not applicable, as no clinical study with a test set requiring adjudication was performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. This device is an X-ray flat panel detector, not an AI software intended to assist human readers.

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

Not applicable. This is a hardware device (X-ray detector) with associated software for image processing and display, not an AI algorithm. Its performance is inherent in its image acquisition capabilities. The "standalone" performance here refers to the detector's physical performance metrics (DQE, MTF, resolution).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the image quality evaluation mentioned: The ground truth implicitly refers to the ideal image quality parameters as defined by industry standards (e.g., IEC standards for DQE, MTF) and the performance of the legally marketed predicate devices. It is not a clinical ground truth for diagnostic accuracy.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning model that requires a distinct training set in the typical sense. Its "training" would be the engineering and manufacturing processes to ensure it meets its design specifications.

9. How the ground truth for the training set was established

Not applicable, as there is no training set in the context of an AI model for this device. The "ground truth" for the device's development would be its design requirements and engineering specifications validated through non-clinical testing.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" referenced in the document is a compilation of non-clinical performance tests and adherence to voluntary standards.

Non-clinical Performance Data: The device conforms to 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.
FDA Guidance adherence: The "FDA's Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" (September 1, 2016) was followed to describe detector characteristics. Guidance documents for software (June 14, 2023) and cybersecurity (September 27, 2023) were also followed.
Specific Tests Conducted:
- Risk analysis, verification, and validation activities.
- Load-bearing characteristics and protection against ingress of water (passed).
- EMC emission testing (IEC60601-1-2) – results satisfactory.
- Biocompatibility testing (ISO 10993 series) for materials in contact with patients.
- 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. This is the key "performance" study, demonstrating that the new device's images are comparable to those produced by already-cleared devices, implying acceptable clinical usability for its stated indications.

Conclusion stated in the document: Based on these non-clinical studies and comparisons, the manufacturer concluded that the device is "as safe and effective" as the legally marketed predicate devices and does not raise "different questions of safety and effectiveness."

Summary

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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.

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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.

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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

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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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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

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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

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V. DESCRIPTION OF THE DEVICE SUBJECT TO PREMERKET NOTIFI-CATION

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:

1. Detector status update
1. Xray exposure workflow
1. Image viewer and measurement.
1. Post image process and DICOM file I/O
1. 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

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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:

1. Imaging procedure review
1. Worklist settings
1. Detector connection settings
1. Calibration
1. 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.

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Product name	Yushan X-Ray Flat PanelDetector	Yushan X-Ray Flat PanelDetector with DROC	Yushan X-Ray Flat PanelDetector with DROC	Yushan X-Ray Flat PanelDetector with DROC
Model name	V14C	V14C	-	-
	V14G	V14G	-	-
	V17C	V17C	-	-
	V17G	V17G	-	-
	V17Ge	V17Ge	-	-
	F14C	-	F14C	-
	F14G	-	F14G	-
	V17Ce	-	-	V17Ce
Manufacturer	InnoCare OptoelectronicsCorp.	InnoCare OptoelectronicsCorp.	InnoCare OptoelectronicsCorp.	InnoCare OptoelectronicsCorp.
	Qualifiednumber	(Subject Device)	K201528	K210988
Clinical

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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 displayradiographic images of hu-man anatomy. It is intendedfor use in general projectionradiographic applicationswherever conventionalfilm/screen or CR systemsmay be used. The Yushan X-Ray Flat Panel Detector isnot 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 FlatPanel Detector with DROC isintended to capture fordisplay radiographic imagesof human anatomy. It is in-tended for use in general pro-jection radiographic applica-tions wherever conventionalfilm/screen or CR systemsmay be used. The Yushan X-Ray Flat Panel Detector withDROC is not intended formammography, fluoroscopy,tomography, and angi-ography applications.	The Wireless/Wired YushanX-Ray Flat Panel Detectorwith DROC is intended tocapture for display radio-graphic images of humananatomy. It is intended foruse in generalprojection radiographic ap-plications wherever conven-tional film/screen or CR sys-tems may be used. TheYushan X-Ray Flat Panel De-tector with DROC is not in-tended for mammography,fluoroscopy, tomography,and angiography applica-tions.	The Wired Yushan X-RayFlat Panel Detector is in-tended to capture for displayradiographic images of hu-man anatomy. It is intendedfor use in general projectionradiographic applicationswherever conventionalfilm/screen or CR systemsmay be used. The Yushan X-Ray Flat Panel Detector isnot intended for mammogra-phy, fluoroscopy, tomogra-phy, and angiographyapplications. The use of thisproduct is not recommendedfor pregnant women and therisk ofradioactivity must be evalu-ated by a physician.	DQE	V series:GOS: at 1 lp/mm, RQA5 is0.27CsI: at 1 lp/mm, RQA5 is0.48F series:GOS: at 1 lp/mm, RQA5 is0.27CsI: at 1 lp/mm, RQA5 is0.50	GOS: at 1 lp/mm, RQA5 is0.27CsI: at 1 lp/mm, RQA5 is0.48	GOS: at 1 lp/mm, RQA5 is0.27CsI: at 1 lp/mm, RQA5 is0.50	CsI: at 1 lp/mm, RQA5 is0.48
Technical	pregnant women and the riskof radioactivity must be eval-uated by a physician.			MTFMax.resolution	CsI: at 1 lp/mm, RQA5 is0.64GOS: 3.57 lp/mmCsI: 3.57 lp/mm	GOS: at 1 lp/mm, RQA5 is0.52CsI: at 1 lp/mm, RQA5 is0.69GOS: 3.57 lp/mmCsI: 3.57 lp/mm	GOS: at 1 lp/mm, RQA5 is0.52CsI: at 1 lp/mm, RQA5 is0.63GOS: 3.57 lp/mmCsI: 3.57 lp/mm	CsI: at 1 lp/mm, RQA5 is0.69CsI: 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: 2.7V14C: 2.7V17G: 3.2V17C: 3.2V17Ge: 3.5F14G: 2.3F14C: 2.5V17Ce: 3.6	V14G: 2.7V14C: 2.7V17G: 3.2V17C: 3.2V17Ge: 3.5	F14G: 2.3F14C: 2.5	V17Ce: 3.6
Substrate	Glass: For V seriesNon-Glass(polyethylene terephthalatelaminate): For F series	Glass	Non-Glass(polyethylene terephthalatelaminate)	Glass
Scintillator	V14G: GOSV14C: CsIV17G: GOSV17C: CsIV17Ge: GOSF14G: GOSF14C: CsIV17Ce: CsI	V14G: GOSV14C: CsIV17G: GOSV17C: CsIV17Ge: GOS	F14G: GOSF14C: CsI	V17Ce: CsI

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Pixels	V14G: 2500 x 3052V14C: 2500 x 3052V17G: 3072 x 3072V17C: 3072 x 3072V17Ge: 3072 x 3072F14G: 2500 x 3052F14C: 2500 x 3052V17Ce: 3072 x 3072	V14G: 2500 x 3052V14C: 2500 x 3052V17G: 3072 x 3072V17C: 3072 x 3072V17Ge: 3072 x 3072	F14G: 2500 x 3052F14C: 2500 x 3052	V17Ce: 3072 x 3072
Interface	Wired: Gigabit Ethernet(100BASE-TX or10BASE-T)Wireless: IEEE802.11 ac/a/g/n* V17Ge, V17Ce is not ap-plicable for wireless func-tion.	Wired: Gigabit Ethernet(100BASE-TX or10BASE-T)Wireless: IEEE802.11 ac/a/g/n* V17Ge is not applicablefor wireless function.	Wired: Gigabit Ethernet(100BASE-TX or10BASE-T)Wireless: IEEE802.11 ac/a/g/n	Not applicable
Power Source	Rechargeable LithiumBattery* V17Ge, V17Ce is notapplicable for wirelessfunction.	Rechargeable LithiumBattery*not applicable on modelV17Ge	Rechargeable LithiumBattery	Rechargeable LithiumBattery*not applicable on modelV17Ge
Biological
Biologicalsafety	All material contact withpatients are in accordancewith ISO 10993.	All material contact withpatients are in accordancewith ISO 10993.	All material contact withpatients are in accordancewith ISO 10993.	All material contact withpatients are in accordancewith ISO 10993.
Others

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-	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-upcable)
-	SE cable (Back-upcable)	-	SE cable (Back-upcable)	-	SE cable (Back-upcable)	-	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.

Regulation Number and Section

§ 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.