Yushan X-Ray Flat Panel Detector

{0} FDA U.S. FOOD & DRUG ADMINISTRATION 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} 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. {2} 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, 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} FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | 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) | | | 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. | | | 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." | | {4} INCA # 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 {5} INCX 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- {6} INCA 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 PREMERKET NOTIFICATION 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 (Csl). 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: 1. Detector status update 2. Xray exposure workflow 3. Image viewer and measurement 3 of 11 {7} INCA 4. Post image process and DICOM file I/O 5. 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: 1. Imaging procedure review 2. Worklist settings 3. Detector connection settings 4. Calibration 5. 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). # 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: {8} INCA ## 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 {9} INCA | 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 wherever | 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 | 6 of 11 {10} INCA | | 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) V17Ge: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) 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 | Csl | V14C: Csl V14G: GOS V17C: Csl V17G: GOS | V14C: Csl V14G: GOS V17C: Csl V17G: GOS | 7 of 11 {11} INCA | | | V17Ge: GOS F14C: Csl F14G: GOS V17Ce: Csl | V17Ge: GOS F14C: Csl F14G: GOS V17Ce: Csl | | --- | --- | --- | --- | | Pixel Pitch | 140 μm | 140 μm | 140 μm | | DQE | Csl: at 1 lp/mm, RQA5 is 0.60 | V series: GOS: at 1 lp/mm, RQA5 is 0.27 Csl: at 1 lp/mm, RQA5 is 0.48 F series: GOS: at 1 lp/mm, RQA5 is 0.27 Csl: at 1 lp/mm, RQA5 is 0.50 | V series: GOS: at 1 lp/mm, RQA5 is 0.27 Csl: at 1 lp/mm, RQA5 is 0.48 F series: GOS: at 1 lp/mm, RQA5 is 0.27 Csl: at 1 lp/mm, RQA5 is 0.50 | | MTF | Csl: at 1 lp/mm, RQA5 is 0.64 | V series: GOS: at 1 lp/mm, RQA5 is 0.52 Csl: at 1 lp/mm, RQA5 is 0.69 F series: GOS: at 1 lp/mm, RQA5 is 0.27 Csl: at 1 lp/mm, RQA5 is 0.63 | V series: GOS: at 1 lp/mm, RQA5 is 0.52 Csl: at 1 lp/mm, RQA5 is 0.69 F series: GOS: at 1 lp/mm, RQA5 is 0.27 Csl: at 1 lp/mm, RQA5 is 0.63 | | Max. resolution | 3.57 lp/mm | 3.57 lp/mm | 3.57 lp/mm | | A/D Conversion | 16 bit | 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 | 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 | 8 of 11 {12} INCA | | 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) | 9 of 11 {13} INCX # 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. # VII. CONCLUSIONS The modification of the $600\mu \mathrm{m}$ 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 $600\mu \mathrm{m}$ CsI provides superior noise performance and smoother image quality compared to the $400\mu \mathrm{m}$ 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 mar-keted device Yushan X-Ray Flat Panel Detector (K243171, K201528, K210988, K220510), and do not {14} 11 of 11 # INCX raise different questions of safety and effectiveness.