(120 days)
No
The description focuses on the hardware (detector) and basic image acquisition and processing software, with no mention of AI, ML, or related concepts.
No
The device is a digital X-ray detector intended for diagnostic imaging, not for treating diseases or conditions.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the detectors are "intended for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy".
No
The device description clearly states that the Lux HD 35 Detector and Lux HD 43 Detector are digital flat panel detectors with physical components like TFT/PD image sensors, CsI scintillators, and scanning/readout electronics, indicating it is a hardware device with accompanying software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "digital imaging solutions designed to provide general radiographic diagnosis for human anatomy". This describes a device used for imaging the body, not for examining specimens derived from the body (like blood, urine, or tissue samples) outside of the body.
- Device Description: The description details a digital flat panel detector that converts X-rays into digital images. This is consistent with a medical imaging device, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Detecting or measuring substances in biological samples.
- Providing information about a patient's health status based on in vitro analysis.
Therefore, the Lux HD 35 Detector and Lux HD 43 Detector are medical imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes
MQB
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. Based on the risks and intended use, documentation level of the software is basic
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Electrical Safety and EMC testing: 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.
- 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.
- 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).
- 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.
- 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.
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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
2
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
3
Indications for Use
Submission Number (if known)
Device Name
Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over The-Counter Use (21 CFR 801 Subpart C)
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4
iRay Imaging Technology ( Haining ) Limited [510(k)] Application
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
(As Required by 21 CFR 807.92)
-
- Date Prepared [21 CFR 807.92(a)(1)]
August 13, 2024
- Date Prepared [21 CFR 807.92(a)(1)]
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 |
5
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)]
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.
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6
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
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.
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.
7
| 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 is | ||
| indicated for digital imaging | |||
| solution designed for | |||
| providing general radiographic | |||
| system in all general-purpose | |||
| diagnostic procedures. | Same | Same | |
| Indications | |||
| for Use | Focus HD 43 Detector is | ||
| indicated for digital imaging | |||
| solutions designed to provide | |||
| general radiographic diagnosis | |||
| for human anatomy including | |||
| both adult and pediatric | |||
| patients. It is intended to | |||
| replace film/screen systems in | |||
| all general-purpose diagnostic | |||
| procedures. The device is not | |||
| intended for mammography or | |||
| dental applications. | 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. | |||
| The devices are not intended | |||
| for mammography or dental | |||
| applications. | Mars1417V-PSI | ||
| Wireless Digital Flat | |||
| Panel Detector is | |||
| indicated for digital | |||
| imaging solution | |||
| designed for providing | |||
| general radiographic | |||
| diagnosis of human | |||
| anatomy. | |||
| It is intended to | |||
| replace radiographic | |||
| film/screen systems in | |||
| all general-purpose | |||
| diagnostic procedures. | |||
| This device is not | |||
| intended for | |||
| mammography or | |||
| dental applications. |
7. Technological Characteristic [21 CFR 807.92(a)(6)]
8
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
9
| Item | Predicate Device:
Focus HD 43 Detector | Proposed Device:
Lux HD 35 Detector
Lux HD 43 Detector | Reference device
Mars1417V-PSI |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Spatial
Resolution | 5.0 lp/mm | 5.0 lp/mm | 3.4 lp/mm |
| Detective
Quantum
Efficiency
(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) |
| Power
Consumption | Max. 42W | Lux HD 35 Detector:
Max. 30W
Lux HD 43 Detector:
Max. 30W | Max. 13W |
| Communicati
ons | a) Wired (only for service) : Gigabit
Ethernet (1000BASE-T)
b) Wireless: IEEE
802.11a/b/g/n/ac (2.4 GHz / 5 GHz) | a) Wired: Gigabit Ethernet (1000BASE-T)
b) Wireless: IEEE
802.11a/b/g/n/ac/ax (2.4 GHz / 5 GHz) | a) Wired: Gigabit
Ethernet
(1000BASE-T)
b) Wireless: IEEE
802.11a/b/g/n (2.4
GHz / 5 GHz) |
| Imaging
protect Plate | Carbon Fiber Plate | Same | Same |
| Cooling | Air cooling | Same | Same |
| Dimensions | 460 mm × 460 mm × 15mm | Lux HD 35 Detector
384mm× 460 mm × 15mm
Lux HD 43 Detector
460mm× 460 mm × 15mm | 384 mm × 460 mm ×
15mm |
| Detector IP
grade | IP56 | IP67 | / |
| Item | Predicate Device:
Focus HD 43 Detector | Proposed Device:
Lux HD 35 Detector
Lux HD 43 Detector | Reference device
Mars1417V-PSI |
| Power input
port | 10 pin port | 10 pin port | 4 Pin port |
| Frame
material | Aluminum alloy | Carbon fiber | Aluminum alloy |
| Surface
pressure | Uniform load: 300 kg over
the whole area of the surface;
Local load: 100 kg on an area
4 cm diameter of center | Uniform load: 300 kg over
the whole area of the
surface;
Local load: 150 kg on an
area 4 cm diameter of center | / |
| Operation | Temperature: +5 ~ +35°C
Humidity: 5 ~ 90%
(Non-Condensing)
Atmospheric pressure: 70 ~
106 kPa
Altitude: Max. 3000 meters | Temperature: +5 ~ +35°C
Humidity: 5 ~ 90%
(Non-Condensing)
Atmospheric pressure: 70 ~
106 kPa
Altitude: Max. 3000 meters | Temperature: +5 ~
+35°C
Humidity: 30 ~ 75%
(Non-Condensing)
Atmospheric pressure:
70 ~ 106 kPa
Altitude: Max. 3000
meters |
| Storage and
Transportation:
( detector ) | Temperature: -20 ~ +55°C
Humidity: 5 ~ 95%
(Non-Condensing)
Atmospheric pressure: 70 ~
106 kPa
Altitude: Max. 3000 meters | Temperature: -10 to + 60°C.
(Excluding battery)
Relative Humidity: 5 to
95%, non-condensing.
Atmosphere: 700mBar
~1060mBar
Altitude: Max. 3000 meter | Temperature: -20 ~
+55°C
Humidity: 10 ~ 90%
(Non-Condensing)
Atmospheric pressure:
70 ~ 106 kPa
Altitude: Max. 3000
meters |
| Item | Predicate Device:
Focus HD 43 Detector | Proposed Device:
Lux HD 35 Detector
Lux HD 43 Detector | Reference device
Mars1417V-PSI |
| Software | SDK(include iDetector)
The software is intend to
supply API interface for DR
system manufacturers. DR
system manufacturer control
the detector by SDK interface.
SDK is not intend to use
directly by other users beside
DR system manufacturers. | Digital Radiographic
Imaging Acquisition
Software Platform – DR
The software used for
getting Digital X-ray
radiography images from
the flat panel detectors.
The software is used to
handle the DICOM protocol
(DICOM 3.0).
The software is responsible
for the DR equipment
management, acquisition
and processing functions, to
provide patient registration,
scanning, image processing
and other functions. | iRayDR
The software used for
getting Digital X-ray
radiography images
from the flat panel
detectors.
The software is used
to handle the DICOM
protocol (DICOM
3.0).
The software is
responsible for the DR
equipment
management,
acquisition and
processing functions,
to provide patient |
| | | | registration, scanning,
image processing,
image forwarding,
image printing and
other functions. |
| Item | Predicate Device: | Proposed Device: | Reference device |
| | Focus HD 43 Detector | Lux HD 35 Detector
Lux HD 43 Detector | Mars1417V-PSI |
| Utilized FDA
guidance
documents | 1. Guidance for the
Submission of 510(k)'s for
Solid State X-ray Imaging
Devices; | Same | / |
| | 2. The 510(k) Program:
Evaluating Substantial
Equivalence in Premarket
Notifications[510(k)]; | Additionally, the following
FDA guidance documents
are applied
-
Content of Premarket
Submissions for Device
Software Functions
Guidance for Industry
and Food and Drug
Administration Staff
June 2023 -
Pediatric Information
for X-ray Imaging
Device Premarket
Notifications Guidance
for Industry and Food
and Drug
Administration Staff
November 2017 -
Cybersecurity in
Medical Devices:
Quality System
Considerations and
Content of Premarket | |
| | 3. Content of Premarket
Submissions for
Management of
Cybersecurity in Medical
Devices; | | |
| | 4. Radio Frequency Wireless
Technology in Medical
Devices. | | |
| | 5. Guidance for “Premarket
Assessment of Pediatric
Medical Devices”; | | |
| | 6. Guidance for “Pediatric
Information for X-ray
Imaging Device Premarket
Notifications”. | | |
| | 7. Design Control Guidance
For Medical Device
Manufacturers | | |
| Item | Predicate Device: | Proposed Device: | Reference device |
| | Focus HD 43 Detector | Lux HD 35 Detector | Mars1417V-PSI |
| | | Lux HD 43 Detector | |
| 8. | Appropriate Use of
Voluntary Consensus
Standards in Premarket
Submissions for Medical
Devices. | Submissions Guidance
for Industry and Food
and Drug
Administration Staff
September 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
13
iRay Imaging Technology ( Haining ) Limited [510(k)] Application
8. System requirements to operate with other radiographic system components
-
- Recommended Generator Specification:
Energy range: 40~150kVp
- Recommended Generator Specification:
mA range: 10~1000mA (depending on the generator power)
ms range: 106300ms to produce 0.11000mAs (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.
-
- 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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-
- 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.
- X-ray exposure mode
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. -
- 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.
- Biological Evaluation:
-
- 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).
- Non-clinical Considerations:
-
- 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.
- Clinical Consideration:
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-
- 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.
- Wireless testing
-
- 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.
- Cybersecurity testing
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.