The Wireless and Wired 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 is static digital x-ray detector, model V14C PLUS, F14C PLUS, V17C PLUS are portable (wireless/ wired) detectors, while V17Ce PLUS is a non-portable (wired) detector. The Subject Device is equivalent to it's predicate device K243171, K201528, K210988, and K220510.

The Subject Device 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. The Subject Device has memory exposure mode, and extended image readout feature. 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.The Detector is currently indicated for general projection radiographic applications and the scintillator material is cesium iodide (CsI).

The Subject Device can automatically collect x-ray images from an x-ray source. It collects x-rays and digitizes the images for their transfer and display to a computer. The x-ray generator (an integral part of a fully-functional diagnostic system) is not part of the device. The sensor includes a flat panel for x-ray acquisition and digitization and a computer (including proprietary processing software) for processing, annotating and storing x-ray images.

The Subject Device is working by using DROC (Digital Radiography Operating Console), Xresta or DR console, which are unchanged from the predicate device, cleared under K201528 for DROC and K243171 for Xresta and DR console. The DROC or Xresta is a software running on a Windows PC/Laptop as a 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 or Xresta supports 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:

Imaging procedure review
Worklist settings
Detector connection settings
Calibration
Image processing

The software level of concern for the Yushan X-Ray Flat Panel Detector with DROC, Xresta, or DR Console has been determined to be basic based on the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"; and the cybersecurity risks of the Yushan X-Ray Flat Panel Detector with DROC, Xresta, or DR Console 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).

AI/ML Overview

Acceptance Criteria and Study for Yushan X-Ray Flat Panel Detector (K250211)

This documentation describes the acceptance criteria and the study conducted for the Yushan X-Ray Flat Panel Detector (models V14C PLUS, F14C PLUS, V17C PLUS, V17Ce PLUS). The device has received 510(k) clearance (K250211) based on substantial equivalence to predicate devices (K243171, K201528, K210988, K220510).

The primary change in the subject device compared to its predicates is an increase in the CsI scintillator thickness from 400µm (in some predicate CsI models) to 600µm. This change impacts image quality metrics but, according to the manufacturer, does not introduce new safety or effectiveness concerns.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating that the changes in scintillator thickness do not negatively impact safety or effectiveness, and ideally, improve image quality. The primary performance metrics affected by the scintillator change are DQE, MTF, and Sensitivity.

Performance Metric	Acceptance Criteria (Implicit: No degradation in clinical utility compared to predicate, ideally improvement)	Reported Device Performance (Subject Device - 600µm CsI)	Predicate Device (CsI Models - 400µm CsI) Performance
DQE (Detective Quantum Efficiency) @ 1 lp/mm, RQA5	Maintain or improve upon predicate's CsI DQE value.	0.60 (Typical)	0.48 - 0.50
DQE (Detective Quantum Efficiency) @ 2 lp/mm	(Not explicitly stated for acceptance, but shown for performance)	0.45 (Typical)	Not explicitly listed for predicate
MTF (Modulation Transfer Function) @ 1 lp/mm, RQA5	Maintain comparable MTF to predicate's CsI MTF (acknowledging potential trade-offs for improved DQE).	0.64 (Typical)	0.63 - 0.69
MTF (Modulation Transfer Function) @ 2 lp/mm	(Not explicitly stated for acceptance, but shown for performance)	0.34 (Typical)	Not explicitly listed for predicate
Sensitivity	(Not explicitly stated for acceptance, but shown for performance)	715 lsb/uGy	Not explicitly listed for predicate
Noise Performance	Superior noise performance compared to predicate.	Superior noise performance	Inferior to subject device
Image Smoothness	Smoother image quality compared to predicate.	Smoother image quality	Inferior to subject device
Compliance with Standards	Conformance to relevant safety and performance standards (e.g., IEC 60601 series, ISO 10993).	All specified standards met.	All specified standards met.
Basic Software Level of Concern	Maintained as basic.	Level of concern remains basic.	Level of concern remains basic.
Cybersecurity Risks	No new or increased cybersecurity risks introduced.	Risks addressed, no new or increased risks.	Risks addressed.
Load-Bearing Characteristics	Pass specified tests.	Passed.	Passed.
Protection against ingress of water	Pass specified tests.	Passed.	Passed.
Biocompatibility	Demonstrated through ISO 10993 series.	Demonstrated.	Demonstrated.

Summary of Device Performance vs. Acceptance:
The subject device demonstrates improved DQE, superior noise performance, and smoother images compared to the predicate device (specifically, CsI models), while maintaining comparable MTF and meeting all other safety and performance standards. The slight reduction in MTF compared to the highest performing predicate CsI model (0.69 vs 0.64 at 1 lp/mm) is likely considered an acceptable trade-off given the improvements in DQE and noise, and it is still significantly higher than GOS models.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample size for the test set used for the performance evaluation of the image quality metrics (DQE, MTF, Sensitivity, noise, smoothness). These metrics are typically derived from physical measurements on a controlled test setup rather than a clinical image dataset.

Data Provenance: Not explicitly stated regarding country of origin or retrospective/prospective nature. However, the evaluation results for image quality metrics, noise, and smoothness are generated internally by the manufacturer during design verification and validation activities.

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

Not applicable. The ground truth for DQE, MTF, and Sensitivity measurements is established through standardized physical phantom measurements (e.g., using RQA5 beam quality) rather than expert consensus on clinical images. These are quantifiable engineering parameters.

4. Adjudication Method for the Test Set

Not applicable. The evaluation of DQE, MTF, and Sensitivity is based on objective instrumental measurements, not on reader interpretations or consensus methods.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed as part of this 510(k) submission. The submission focuses on demonstrating substantial equivalence based on technical specifications and physical performance measurements rather than a clinical trial assessing reader performance.

6. Standalone Performance Study

Yes, a standalone performance evaluation was conducted for the device. The reported DQE, MTF, and Sensitivity values, as well as the assessments of noise performance and image smoothness, are measures of the algorithm's (and the underlying detector hardware's) intrinsic performance without human-in-the-loop assistance. The comparison of these metrics between the subject device and the predicate device forms the basis of the standalone performance study.

7. Type of Ground Truth Used

The ground truth used for the performance evaluations (DQE, MTF, Sensitivity, noise, smoothness) is based on objective physical measurements and standardized phantom evaluations. These are quantitative technical specifications derived under controlled laboratory conditions, not expert consensus on pathology, clinical outcomes, or interpretations of patient images.

8. Sample Size for the Training Set

Not applicable. This device is an X-ray flat panel detector, a hardware component that captures images. While it includes embedded software (firmware, image processing algorithms), the document does not indicate that these algorithms rely on a "training set" in the context of machine learning. The image processing algorithms are likely deterministic or parameter-tuned, not learned from a large dataset like an AI model for diagnosis.

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

Not applicable, as there is no indication of a machine learning "training set" as described in the context of AI models. The ground truth for the development and validation of the detector's physical performance characteristics is established through established metrology and engineering testing protocols.

Summary

U.S. Food & Drug Administration 510(k) Clearance Letter

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

July 22, 2025

InnoCare Optoelectronics Corp.
℅ Christy Huang
Quality Engineer
InnoCare Optoelectronics Corp.
Rm. B, No. 2, Sec. 2, Huanxi Rd., Southern Taiwan Science Park
Xinshi Dist., Tainan 741
TAIWAN

Re: K250211
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: MQB
Dated: January 22, 2025
Received: June 23, 2025

Dear Christy Huang:

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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K250211 - Christy Huang Page 2

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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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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K250211 - Christy Huang Page 3

See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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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FORM FDA 3881 (8/23) Page 1 of 1

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K250211

Device Name: Yushan x-ray flat panel detector

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

K250211

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 # 21520
Email: regulatoryaffairs@innocare-x.com
Contact Person: Christy Huang/ Quality Engineer
Date Prepared: January 22, 2025

II. DEVICE

Trade name: Yushan X-Ray Flat Panel Detector
Model name: V14C PLUS, F14C PLUS, V17C PLUS, V17Ce PLUS
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
FDA 510(k) clearance number: K243171
Manufacturer: InnoCare Optoelectronics Corp.
Regulation description: Stationary x-ray system.
Review panel: Radiology
Product code: MQB
Regulation number: 21 CFR 892.1680
Device class: Class II

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b.

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
Device class: Class II

c.

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
Device class: Class II

d.

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
Device class: Class II

IV. INDICATIONS FOR USE

The Wireless and Wired Yushan X-Ray Flat Panel Detector is intended to capture for display radio-

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graphic 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.

V. DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION

Detector status update
Xray exposure workflow
Image viewer and measurement

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Post image process and DICOM file I/O
Image database: DROC or Xresta supports the necessary DICOM Services to allow a smooth integration into the clinical network

Imaging procedure review
Worklist settings
Detector connection settings
Calibration
Image processing

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Compare to the predicate device, The Subject Device only made changes in the CsI scintillator thickness, DQE, MTF, and Sensitivity. Other portion, such as the software DROC, Xresta, DR Console are unchanged compare to the predicate device (K243171, K201528), the circuit design, operating principle, mechanism design...etc. are also unchanged compare to the predicate device (K243171). Change in the thickness of Scintillator trigger differences in image quality metrics (DQE, MTF, Sensitivity) in the Subject Device as compared to the Predicate Device (K243171, K201528). The details of changes to The Subject Device include:

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DQE (Detective Quantum Efficiency)

0.60 @ 1 lp/mm (Typical)
0.45 @ 2 lp/mm (Typical)

MTF (Modulation Transfer Function)

0.64 @ 1 lp/mm (Typical)
0.34 @ 2 lp/mm (Typical)

Sensitivity

715 lsb/uGy

Thickness of Scintillator

Thickness of Scintillator: 600um

The Subject Device has the higher DQE ratio than the predicate device, that means the better SNR (signal to noise ration) and reflect to the image quality. The Subject Device has the slightly less MTF than the CsI model of predicate device but the significantly higher MTF than the GOS model of predicate device. These changes on The Subject Device would not change the intended use, indications for use, and there are no new safety and effectiveness issues being raised, compared to the predicate device.

The comparisons of technological characteristics are listed in the following table below

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Feature	Subject Device	Predicate Device	Predicate Device
510(K)	K250211	K243171	K201528, K210988, K220510
Product name	Yushan X-Ray Flat Panel Detector with DROC, Xresta, DR Console	Yushan X-Ray Flat Panel Detector with Xresta, DR Console	Yushan X-Ray Flat Panel Detector with DROC
Model Name	V14C PLUS	V14C	V14C(K201528)
	-	V14G	V14G(K201528)
	V17C PLUS	V17C	V17C(K201528)
	-	V17G	V17G(K201528)
	-	V17Ge	V17Ge(K201528)
	F14C PLUS	F14C	F14C(K210988)
	-	F14G	F14G(K210988)
	V17Ce PLUS	V17Ce	V17Ce(K220510)
Manufacturer	InnoCare Optoelectronics Corp.	InnoCare Optoelectronics Corp.	InnoCare Optoelectronics Corp.

Feature	Subject Device	Predicate Device	Predicate Device
Indications for Use	The Wireless and Wired 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	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 human anatomy. It is intended for use in general projection radiographic applications	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 projection radiographic applications wherever

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Feature	Subject Device	Predicate Device	Predicate Device
	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.	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.	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.
Dimensions (mm)	V14C PLUS:460(W)×383(L)×15(H), V17C PLUS:460(W)×460(L)×15(H), F14C PLUS: 460(W)×383(L)×15(H), V17Ce PLUS:460(W)×460(L)×15(H)	V14C:460(W)×383(L)×15(H), V14G:460(W)×383(L)×15(H), V17C:460(W)×460(L)×15(H), V17G:460(W)×460(L)×15(H), V17Ge:460(W)×460(L)×15(H), F14C:460(W)×383(L)×15(H), F14G:460(W)×383(L)×15(H), V17Ce:460(W)×460(L)×15(H)	V14C:460(W)×383(L)×15(H), V14G:460(W)×383(L)×15(H), V17C:460(W)×460(L)×15(H), V17G:460(W)×460(L)×15(H), V17Ge:460(W)×460(L)×15(H), F14C:460(W)×383(L)×15(H), F14G:460(W)×383(L)×15(H), V17Ce:460(W)×460(L)×15(H)
Weight (Kg)	V14C PLUS: 2.9, V17C PLUS: 3.55, F14C PLUS: 2.9, V17Ce PLUS: 3.9	V14C: 2.7, V14G: 2.7, V17C: 3.2, V17G: 3.2, V17Ge: 3.5, F14C: 2.3, F14G: 2.5, V17Ce: 3.6	V14C: 2.7, V14G: 2.7, V17C: 3.2, V17G: 3.2, V17Ge: 3.5, F14C: 2.3, F14G: 2.5, V17Ce: 3.6
Substrate	Glass: For V series, Non-Glass (polyethylene terephthalate laminate): For F series	Glass: For V series, Non-Glass (polyethylene terephthalate laminate): For F series	Glass: For V series, Non-Glass (polyethylene terephthalate laminate): For F series
Scintillator	CsI	V14C: CsI, V14G: GOS, V17C: CsI, V17G: GOS	V14C: CsI, V14G: GOS, V17C: CsI, V17G: GOS

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	V17Ge: GOS, F14C: CsI, F14G: GOS, V17Ce: CsI	V17Ge: GOS, F14C: CsI, F14G: GOS, V17Ce: CsI
Pixel Pitch	140 μm	140 μm
DQE	CsI: at 1 lp/mm, RQA5 is 0.60	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
MTF	CsI: at 1 lp/mm, RQA5 is 0.64	V series: GOS: at 1 lp/mm, RQA5 is 0.52, CsI: at 1 lp/mm, RQA5 is 0.69, F series: GOS: at 1 lp/mm, RQA5 is 0.27, CsI: at 1 lp/mm, RQA5 is 0.63
Max. resolution	3.57 lp/mm	3.57 lp/mm
A/D Conversion	16 bit	16 bit
Pixels	V14C PLUS:2500 x 3052, V17C PLUS:3072 x 3072, F14C PLUS:2500 x 3052	V14C: 2500 x 3052, V14G: 2500 x 3052, V17C: 3072 x 3072, V17G: 3072 x 3072, V17Ge: 3072 x 3072, F14C: 2500 x 3052, F14G: 2500 x 3052

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	V17Ce PLUS:3072 x 3072	V17Ce: 3072 x 3072	V17Ce: 3072 x 3072
Interface	Wired: Gigabit Ethernet (100BASE-TX or 10BASE-T), Wireless: IEEE802.11 ac /a/g/n, * V17Ce PLUS is not applicable for wireless function.	Wired: Gigabit Ethernet (100BASE-TX or 10BASE-T), Wireless: IEEE802.11 ac /a/g/n, * V17Ge, V17Ce is not applicable for wireless function.	Wired: Gigabit Ethernet (100BASE-TX or 10BASE-T), Wireless: IEEE802.11 ac /a/g/n, * V17Ge, V17Ce is not applicable for wireless function.
Power Source	Rechargeable Lithium Battery, *not applicable on model V17Ce PLUS	Rechargeable Lithium Battery, *not applicable on model V17Ge, V17Ce	Rechargeable Lithium Battery, *not applicable on model V17Ge, V17Ce
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.
Accessories	- Battery (Not applicable to V17Ce PLUS), - Power supply (Adapter), - SE cable (Back-up cable), - Power Cord, - Charger (Not applicable to V17Ce PLUS), - Charger Adapter (Not applicable to V17Ce PLUS), - DROC Dongle (Optional), - Xresta Dongle (Optional), - DR Console (Optional)	- Battery (Not applicable to V17Ge, V17Ce), - Power supply (Adapter), - SE cable (Back-up cable), - Power Cord, - Charger (Not applicable to V17Ge, V17Ce), - Charger Adapter (Not applicable to 17Ge, V17Ce), - Xresta Dongle (Optional), - DR Console (Optional)	- Battery (Not applicable to V17Ge, V17Ce), - Power supply (Adapter), - SE cable (Back-up cable), - Power Cord, - Charger (Not applicable to V17Ge, V17Ce), - Charger Adapter (Not applicable to 17Ge, V17Ce), - DROC Dongle (Optional)

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VII. PERFORMANCE DATA

Yushan X-Ray Flat Panel Detector (V14C PLUS, F14C PLUS, V17C PLUS, V17Ce PLUS) conforms 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; Guidance for the 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 the device. 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. Additionally, the risk analysis, necessary verification and validation activities were performed.

In the Substantial Equivalence Comparison, the evaluation of the impact of different scintillator thicknesses on the image quality of FPDs shows the Subject Device provides lower noise performance and a smoother image compared to that of the predicate device. The comparisons of technological characteristics show the thicker CsI scintillator only change in DQE, MTF, Sensitivity and due to this change there are no new safety and effectiveness issues being raised. These testing result and image quality evaluation support the claims of substantial equivalence to that of the predicate device.

VIII. CONCLUSIONS

The modification of the 600μm CsI scintillator has been thoroughly evaluated and is deemed acceptable, as it does not significantly impact the safety, effectiveness, or intended use of the cleared model. Yushan X-Ray Flat Panel Detector (V14C PLUS, F14C PLUS, V17C PLUS, V17Ce PLUS) is designed to comply with applicable federal and international safety and performance standards. Experimental results also confirm that the 600μm CsI provides superior noise performance and smoother image quality compared to the 400μm CsI, without clinically significant degradation of details or edges. Based upon the supporting data summarized above, we concluded the Yushan X-Ray Flat Panel Detector (V14C PLUS, F14C PLUS, V17C PLUS, V17Ce PLUS) is as safe and effective as the legally marketed device Yushan X-Ray Flat Panel Detector (K243171, K201528, K210988, K220510), and do not

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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.