Lux HD 35 Detector and Lux HD 43 Detector are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general-purpose diagnostic procedures. Lux HD 35 Detector and Lux HD 43 Detector are not intended for mammography or dental applications.

Device Description

Lux HD 35 Detector and Lux HD 43 Detector are digital flat panel detector. They support the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 35cm×43cm (Lux HD 35 Detector)/42.67cm × 42.67cm (Lux HD 43 Detector) .The differences between two models are overall change in the dimensions of the image receptor. The sensor plate of Lux HD 35 Detector and Lux HD 43 Detector is direct-deposited with CsI scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics, consequently to form a panel image by transmitting to PC through the user interface. The major function of the Lux HD 35 Detector and Lux HD 43 Detector is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. Both kinds of detectors are the key component of DR system. The Digital Radiographic Imaging Acquisition Software Platform - DR is part of the system, it is used to acquire, enhance, view image from Lux HD 35 Detector and Lux HD 43 Detector.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Lux HD 35 Detector and Lux HD 43 Detector). It details the device's characteristics, intended use, and comparison to a predicate device to demonstrate substantial equivalence.

However, the provided document does not contain information about the acceptance criteria nor a study that proves the device meets specific performance criteria through a clinical evaluation involving human readers, ground truth establishment, or sample sizes related to AI/algorithm performance.

The "Non-clinical study" section primarily discusses:

Electrical Safety and EMC testing: Adherence to IEC/ES 60601-1 and IEC 60601-1-2.
Biological Evaluation: Evaluation of materials contacting operators/patients based on FDA guidance.
Non-clinical Considerations: Stating substantial equivalence to the predicate device for non-clinical aspects mentioned in FDA guidance for solid-state X-ray imaging devices.
Clinical Consideration: Stating that intended use, fundamental scientific technology, regulatory requirements, non-clinical performance, labeling, and quality-assurance programs are the same as the predicate device. It explicitly mentions: "There is no any negative change about clinical performance from predicate device."
Wireless testing: Compliance with ANSI IEEE C63.27-2017.
Cybersecurity testing: Compliance with section 524B(b)(2) of the Federal Food, Drug, and Cosmetics Act.

This submission clearly relies on demonstrating substantial equivalence to a predicate device (Carestream Health, Inc. Focus HD 43 Detector, K213529) through technical and safety comparisons, rather than presenting a performance study with acceptance criteria and results for an AI/algorithm.

Therefore, I cannot populate the table or answer the specific questions about "acceptance criteria and the study that proves the device meets the acceptance criteria" as they pertain to AI/algorithm performance, ground truth, expert adjudication, or MRMC studies. The document does not describe such a study.

The crucial information regarding acceptance criteria and performance data for an AI/algorithm, as requested in your prompt, is absent from the provided text. The document is a 510(k) a summary for a hardware device (X-ray detector) and focuses on the safety and performance equivalency to a predicate hardware device. It does not provide data on AI/algorithm performance against a clinical ground truth.

If this device were to include an AI component that required such a study for its clearance, that information would typically be detailed in a separate section of the 510(k) submission, outlining the AI's intended use, performance metrics, validation strategy, and results against a defined ground truth. This document does not contain that.

Summary

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March 18, 2025

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and name on the right. The FDA part of the logo is in blue, with the acronym in a square and the name "U.S. Food & Drug Administration" written out next to it.

iRay Imaging Technology (Haining) Limited % Junjie Oian Registration & Regulatory Affairs Engineer No. 2, Caohejing Rd. Haining 314499 JIAXING, ZHEJIANG CHINA

Re: K243556

Trade/Device Name: Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: MQB Dated: August 20, 2024 Received: December 31, 2024

Dear Junjie Qian:

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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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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,

Digitally signed by for Gabriela M. Rodal -S Gabriela M. Rodal -5/7

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

Submission Number (if known)

K243556

Device Name

Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)

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)

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iRay Imaging Technology ( Haining ) Limited [510(k)] Application

510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

(As Required by 21 CFR 807.92)

1. Date Prepared [21 CFR 807.92(a)(1)]
  August 13, 2024

2. Submitter's Information [21 CFR 807.92(a)(1)]

Company Name:	iRay Imaging Technology (Haining) Limited
Company Address:	No. 2, Caohejing RD., Haining 314499, Jiaxing, Zhejiang, China
Contact Person:	Junjie Qian
Phone:	0573-87399739
Email:	Junjie.qian@iraygroup.com

3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

Trade Name:	Lux HD 35 Detector (Lux HD 35
	Lux HD 43 Detector (Lux HD 43
Common Name:	Solid State X-Ray Imager
Model Name:	Lux HD 35
	Lux HD 43
Classification Name:	Stationary X-Ray System
Product Code:	MQB
Regulation Number:	21 CFR 892.1680
Device Class:	Class II

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4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)[

The identification predicates within this submission are as follows:

Manufacturer:	Carestream Health, Inc
Trade Name:	Focus HD 43 Detector
Model Name:	Focus HD 43
Product Code:	MQB
Classification Name:	Stationary X-Ray System
Regulation Number:	21 CFR 892.1680
Device Class:	Class II
FDA 510 (k) #:	K213529

5. Description of the Device [21 CFR 807.92(a)(4)]

The sensor plate of Lux HD 35 Detector and Lux HD 43 Detector is direct-deposited with CsI scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics, consequently to form a panel image by transmitting to PC through the user interface.

The major function of the Lux HD 35 Detector and Lux HD 43 Detector is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. Both kinds of detectors are the key component of DR system.

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The Digital Radiographic Imaging Acquisition Software Platform - DR is part of the system, it is used to acquire, enhance, view image from Lux HD 35 Detector and Lux HD 43 Detector. Based on the risks and intended use, documentation level of the software is basic

6. Intended Use [21 CFR 807.92(a)(5)]

6.1. Indications for use

6.2. Suitable patient

Lux HD 35 Detector and Lux HD 43 Detector are suitable for providing digital Xray imaging for DR system to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients, but not intended for mammography or dental applications. The remaining notes depend on the DR system.

6.3. Processing of input and output

When Lux HD 35 Detector and Lux HD 43 Detector work continuously, it can automatically distinguish X-ray and output an imaging for diagnosis of disease, injury, or of any applicable health problem.

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Item	Predicate Device:	Proposed Device:	Reference device
	Focus HD 43 Detector	Lux HD 35 Detector	Mars1417V-PSI
		Lux HD 43 Detector
510(K)Number	K213529	K243556	K161730
Intended Use	The Focus HD 43 Detector isindicated for digital imagingsolution designed forproviding general radiographicsystem in all general-purposediagnostic procedures.	Same	Same
Indicationsfor Use	Focus HD 43 Detector isindicated for digital imagingsolutions designed to providegeneral radiographic diagnosisfor human anatomy includingboth adult and pediatricpatients. It is intended toreplace film/screen systems inall general-purpose diagnosticprocedures. The device is notintended for mammography ordental applications.	Lux HD 35 Detector andLux HD 43 Detector areindicated for digital imagingsolutions designed toprovide general radiographicdiagnosis for humananatomy including bothadult and pediatric patients.They are intended to replacefilm/screen systems in allgeneral-purpose diagnosticprocedures.The devices are not intendedfor mammography or dentalapplications.	Mars1417V-PSIWireless Digital FlatPanel Detector isindicated for digitalimaging solutiondesigned for providinggeneral radiographicdiagnosis of humananatomy.It is intended toreplace radiographicfilm/screen systems inall general-purposediagnostic procedures.This device is notintended formammography ordental applications.

7. Technological Characteristic [21 CFR 807.92(a)(6)]

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Predicate Device: Proposed Device: Reference device Item Lux HD 35 Detector Focus HD 43 Detector Mars1417V-PSI Lux HD 43 Detector Classification Stationary X-ray system Same Same Name Product Code MQB Same Same Regulation 21 CFR 892.1680 Same Same Number Panel Radiology Same Same Classification II Same Same X-Ray Gd2O2S CsI CSI Absorber (Scintillator) Installation Wireless, Portable Wireless or Wired Wireless, Portable Type Readout Thin Film Transistor Same Same Mechanism Lux HD 35 Detector: 2304 × 2800 pixels Image Matrix 4267 × 4267 pixels 3500 × 4300pixels Size Lux HD 43 Detector: 4267 × 4267 pixels Pixel Size 100um 100um 150um ADC 16 bit 16 bit 14 bit Digitization Effective Lux HD 35 Detector: 426.7 mm × 426.7mm 355 mm × 434mm Imaging Area 350mm×430mm Lux HD 43 Detector: 426.7 mm × 426.7mm

[510(k)] Application iRay Imaging Technology (Haining)Limited

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Item	Predicate Device:Focus HD 43 Detector	Proposed Device:Lux HD 35 DetectorLux HD 43 Detector	Reference deviceMars1417V-PSI
SpatialResolution	5.0 lp/mm	5.0 lp/mm	3.4 lp/mm
DetectiveQuantumEfficiency(DQE)	0.54 at 1 lp/mm (RQA5,2.5µGy)	0.54 at 1 lp/mm (RQA5,2.5µGy)	0.27 at 0.5 lp/mm(RQA5, 3.2µGy)
PowerConsumption	Max. 42W	Lux HD 35 Detector:Max. 30WLux HD 43 Detector:Max. 30W	Max. 13W
Communications	a) Wired (only for service) : GigabitEthernet (1000BASE-T)b) Wireless: IEEE802.11a/b/g/n/ac (2.4 GHz / 5 GHz)	a) Wired: Gigabit Ethernet (1000BASE-T)b) Wireless: IEEE802.11a/b/g/n/ac/ax (2.4 GHz / 5 GHz)	a) Wired: GigabitEthernet(1000BASE-T)b) Wireless: IEEE802.11a/b/g/n (2.4GHz / 5 GHz)
Imagingprotect Plate	Carbon Fiber Plate	Same	Same
Cooling	Air cooling	Same	Same
Dimensions	460 mm × 460 mm × 15mm	Lux HD 35 Detector384mm× 460 mm × 15mmLux HD 43 Detector460mm× 460 mm × 15mm	384 mm × 460 mm ×15mm
Detector IPgrade	IP56	IP67	/
Item	Predicate Device:Focus HD 43 Detector	Proposed Device:Lux HD 35 DetectorLux HD 43 Detector	Reference deviceMars1417V-PSI
Power inputport	10 pin port	10 pin port	4 Pin port
Framematerial	Aluminum alloy	Carbon fiber	Aluminum alloy
Surfacepressure	Uniform load: 300 kg overthe whole area of the surface;Local load: 100 kg on an area4 cm diameter of center	Uniform load: 300 kg overthe whole area of thesurface;Local load: 150 kg on anarea 4 cm diameter of center	/
Operation	Temperature: +5 ~ +35°CHumidity: 5 ~ 90%(Non-Condensing)Atmospheric pressure: 70 ~106 kPaAltitude: Max. 3000 meters	Temperature: +5 ~ +35°CHumidity: 5 ~ 90%(Non-Condensing)Atmospheric pressure: 70 ~106 kPaAltitude: Max. 3000 meters	Temperature: +5 ~+35°CHumidity: 30 ~ 75%(Non-Condensing)Atmospheric pressure:70 ~ 106 kPaAltitude: Max. 3000meters
Storage andTransportation:( detector )	Temperature: -20 ~ +55°CHumidity: 5 ~ 95%(Non-Condensing)Atmospheric pressure: 70 ~106 kPaAltitude: Max. 3000 meters	Temperature: -10 to + 60°C.(Excluding battery)Relative Humidity: 5 to95%, non-condensing.Atmosphere: 700mBar~1060mBarAltitude: Max. 3000 meter	Temperature: -20 ~+55°CHumidity: 10 ~ 90%(Non-Condensing)Atmospheric pressure:70 ~ 106 kPaAltitude: Max. 3000meters
Item	Predicate Device:Focus HD 43 Detector	Proposed Device:Lux HD 35 DetectorLux HD 43 Detector	Reference deviceMars1417V-PSI
Software	SDK(include iDetector)The software is intend tosupply API interface for DRsystem manufacturers. DRsystem manufacturer controlthe detector by SDK interface.SDK is not intend to usedirectly by other users besideDR system manufacturers.	Digital RadiographicImaging AcquisitionSoftware Platform – DRThe software used forgetting Digital X-rayradiography images fromthe flat panel detectors.The software is used tohandle the DICOM protocol(DICOM 3.0).The software is responsiblefor the DR equipmentmanagement, acquisitionand processing functions, toprovide patient registration,scanning, image processingand other functions.	iRayDRThe software used forgetting Digital X-rayradiography imagesfrom the flat paneldetectors.The software is usedto handle the DICOMprotocol (DICOM3.0).The software isresponsible for the DRequipmentmanagement,acquisition andprocessing functions,to provide patient
			registration, scanning,image processing,image forwarding,image printing andother functions.
Item	Predicate Device:	Proposed Device:	Reference device
	Focus HD 43 Detector	Lux HD 35 DetectorLux HD 43 Detector	Mars1417V-PSI
Utilized FDAguidancedocuments	1. Guidance for theSubmission of 510(k)'s forSolid State X-ray ImagingDevices;	Same	/
	2. The 510(k) Program:Evaluating SubstantialEquivalence in PremarketNotifications[510(k)];	Additionally, the followingFDA guidance documentsare applied1. Content of PremarketSubmissions for DeviceSoftware FunctionsGuidance for Industryand Food and DrugAdministration StaffJune 20232. Pediatric Informationfor X-ray ImagingDevice PremarketNotifications Guidancefor Industry and Foodand DrugAdministration StaffNovember 20173. Cybersecurity inMedical Devices:Quality SystemConsiderations andContent of Premarket
	3. Content of PremarketSubmissions forManagement ofCybersecurity in MedicalDevices;
	4. Radio Frequency WirelessTechnology in MedicalDevices.
	5. Guidance for “PremarketAssessment of PediatricMedical Devices”;
	6. Guidance for “PediatricInformation for X-rayImaging Device PremarketNotifications”.
	7. Design Control GuidanceFor Medical DeviceManufacturers
Item	Predicate Device:	Proposed Device:	Reference device
	Focus HD 43 Detector	Lux HD 35 Detector	Mars1417V-PSI
		Lux HD 43 Detector
8.	Appropriate Use ofVoluntary ConsensusStandards in PremarketSubmissions for MedicalDevices.	Submissions Guidancefor Industry and Foodand DrugAdministration StaffSeptember 2023
9.	The Special 510(k)Program

[510(k)] Application iRay Imaging Technology ( Haining ) Limited

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iRay Imaging Technology ( Haining ) Limited [510(k)] Application

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[510(k)] Application iRay Imaging Technology ( Haining ) Limited

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iRay Imaging Technology ( Haining ) Limited [510(k)] Application

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iRay Imaging Technology ( Haining ) Limited [510(k)] Application

8. System requirements to operate with other radiographic system components

1. Recommended Generator Specification:
  Energy range: 40~150kVp

mA range: 10~1000mA (depending on the generator power)

ms range: 10~~6300ms to produce 0.1~~1000mAs (depending on the generator power) Note: To our best knowledge, the detector is compatible with the X-ray generators with the specifications described above. If you have any questions regarding the compatibility issue for other generators, please contact the distributor or manufacturer's service office.

1. Minimum configuration: Lux HD 43 Detector and Lux HD 35 Detector connected via wireless and wired communication.

Operating System:	Windows 11
CPU:	Intel Core i3- 8100 3.6GHz 4C 65W
Memory:	16GB (2x8GB) DDR4 2666 DIMM
Hard Disk:	1TB

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1. X-ray exposure mode
  The AED trigger module is a unit can connect X-ray signal in the Lux HD 35 Detector and Lux HD 43 Detector. Once there is X-ray generator exposure exist, the AED trigger module will detect the X-ray radiation and output signal to the detector. Until the exposure finished, the detector will receive a signal which represent the end of exposure from the inner trigger module and begin to acquire the image.

9. Non-clinical study

Electrical Safety and EMC testing: 1)
Electrical, mechanical, environmental safety according to IEC/ES 60601-1 was performed, and EMC testing was also conducted in accordance with IEC 60601-1-2. All test results are meet the standard requirements.
1. Biological Evaluation:
  The materials of the detector which contact operators' or patients' skin have been evaluated with the FDA guidance "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". And the evaluation result assured the biological safety.
1. Non-clinical Considerations:
  The non-clinical studies have been performed and the results have shown that sections of the non-clinical consideration mentioned in the 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices' are substantially equivalent to the non-clinical consideration of predicate device on the Market (Focus HD 43 detector, K213529).
1. Clinical Consideration:
  Intended use, fundamental scientific technology, regulatory requirement, non-clinical performance, labeling, quality-assurance program keep the same with those of predicate device. Software keep the same with that of reference device except "image forwarding, image printing" function and literal name. There is no any negative change about clinical performance from predicate device.

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1. Wireless testing
  Wireless functionality and wireless coexistence testing in accordance with ANSI IEEE C63.27-2017 was performed. All test results are meet the standard requirements.
1. Cybersecurity testing
  Cybersecurity threat modeling, risk assessment, and controls and testing were performed to comply with requirements specified in section 524B(b)(2) of the Federal Food, Drug, and Cosmetics Act to provide a reasonable assurance that the subject device with its wireless capabilities are cybersecure.

10. Conclusion [21 CFR 807.92(b)(3)]

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, applicant concludes that Lux HD 35 Detector and Lux HD 43 Detector are substantially equivalent to predicate device with regards to 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.