(30 days)
No
The description focuses on the hardware and basic image processing for converting X-ray to digital images. There is no mention of AI, ML, or advanced algorithms for image analysis or interpretation.
No
This device is a diagnostic tool designed for obtaining digital radiographic images, not for providing therapy. It converts X-rays into digital images for diagnosis.
Yes
The device is described as "designed for providing general radiographic diagnosis of human anatomy," and its purpose is to "convert the X-ray to digital image" which is then used for imaging. This explicitly states its role in diagnosis.
No
The device description clearly details hardware components like a TFT/PD image sensor flat panel, scintillator, diode capacitor array, scanning and readout electronics, and a physical detector that converts X-ray to a digital image. While it mentions software as part of a larger DR system, the device itself is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it is for "digital imaging solution designed for providing general radiographic diagnosis of human anatomy." This involves imaging the internal structures of the body using X-rays, which is an in vivo (within the living body) diagnostic procedure, not in vitro (outside the living body, typically involving samples like blood or tissue).
- Device Description: The description details how the device converts X-rays into digital images of the human anatomy. This aligns with medical imaging, not laboratory testing of samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with IVD devices.
Therefore, the Mars1417XF-GSI Wireless Digital Flat Panel Detector is a medical imaging device used for in vivo diagnosis, not an IVD.
N/A
Intended Use / Indications for Use
Mars1417XF-GSI 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.
Product codes
MQB
Device Description
Mars1417XF-GSI Wireless Digital Flat Panel Detector is a kind of wireless digital flat panel detector. It supports the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 35.04cm×42.54cm.
The sensor plate of Mars1417XF-GSI Wireless Digital Flat Panel Detector is direct-deposited with Gd2O2S 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 Mars1417XF-GSI Wireless Digital Flat Panel Detector is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. This detector is the key component of DR system, enables to complete the digitalization of the medical X-ray imaging with the DR system software.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found
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)
Nonclinical studies were performed to evaluate the substantial equivalence of the Mars1417XF-GSI wireless digital X-ray flat panel detector to the predicate device Mars1417V-PSI (K161730). These studies included:
- Electrical Safety and EMC testing: Performed according to IEC/ES 60601-1 and IEC 60601-1-2. All test results met standard requirements.
- Biological Evaluation: Materials of the detector that contact operators' or patients' skin were evaluated with ISO 10993-1. Evaluation results and test results assured the same safety as the predicate device.
- Nonclinical Considerations: The nonclinical studies have shown that the Mars1417XF-GSI is substantially equivalent to the predicate device Mars1417V-PSI (K161730) for: Detective quantum efficiency (DQE), Quantum limited performance, Modulation transfer function (MTF), Effects of aliasing, Sensitivity linearity, Lag, Change in detection sensitivity, Dose requirement and reciprocity changes, Stability of device characteristics with time, Uniformity of device characteristic, Noise power spectrum (NPS), Spatial resolution, Image Acquisition time, and Black level.
- Software: According to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, the software SDK classifies the hazards, defines requirements specification and design specification. All specifications passed 16 test cases and complied with the intended design specification.
- Clinical Consideration: Nonclinical information was sufficient to support substantial equivalence without the need for additional clinical data, as the only changes were in ADC Digitization, software, and removal of wired communication function.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
iRay Technology Taicang Ltd. Meng Li Registration and Regulatory Affairs Engineer No. 33 Xinggang Rd., Taicang Port Economic & Technological Development Zone TAICANG, JIANGSU 215434 CN
October 17, 2018
Re: K182550
Trade/Device Name: Wireless Digital Flat Panel Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: September 13, 2018 Received: September 17, 2018
Dear Meng Li:
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 (Act) that do not require approval of a premarket approval application (PMA). You mav, 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 avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael D'Hara For
Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K182550
Device Name
Wireless Digital Flat Panel Detector
Indications for Use (Describe)
Mars1417XF-GSI 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.
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------ | ----------------------------------------------- |
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Type of Use (Select one or both, as applicable)
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
3
[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 1st, 2018
2. Submitter;s Information [21 CFR 807.92(a)(1)]
| Company Name: | iRay Technology Taicang Ltd. |
|---|---|
| Company Address: | No.33 Xinggang Road, Taicang Port Economic and |
| Technological Development Zone, Jiangsu, China 215434 | |
| Contact Person: | Meng Li |
| Phone: | 0512-53690872 |
| Fax: | 0512-53690872 |
| Email: | meng.li@iraychina.com |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade Name: | Wireless Digital Flat Panel Detector |
|---|---|
| Common Name: | Solid State X-Ray Imager |
| Model Name: | Mars1417XF-GSI |
| Classification Name: | Stationary X-Ray System |
| Product Code: | MQB |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |
4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)[
The identification predicates within this submission are as follows: Manufacturer: iRay Technology Co.,Ltd.
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4
K182550
iRay Technology Taicang Ltd.
| Trade Name: | Wireless Digital Flat Panel Detector |
|---|---|
| Model Name: | Mars1417V-PSI |
| Product Code: | MQB |
| Classification Name: | Stationary X-Ray System |
| FDA 510 (k) #: | K161730 |
5. Description of the Device [21 CFR 807.92(a)(4)]
Mars1417XF-GSI Wireless Digital Flat Panel Detector is a kind of wireless digital flat panel detector. It supports the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 35.04cm×42.54cm.
The sensor plate of Mars1417XF-GSI Wireless Digital Flat Panel Detector is directdeposited with Gd2O2S 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 Mars1417XF-GSI Wireless Digital Flat Panel Detector is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. This detector is the key component of DR system, enables to complete the digitalization of the medical X-ray imaging with the DR system software.
6. Intended Use [21 CFR 807.92(a)(5)]
6.1. Intended Use
Mars1417XF-GSI 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 generalpurpose diagnostic procedures. This device is not intended for mammography or dental applications.
[510(k)] Application
5
6.2. Suitable patient
It is suitable for providing digital X-ray imaging for DR system conventional photography but not intended for mammography or dental applications. The remaining notes depend on the DR system.
6.3. Processing of input and output
When flat panel detector works continuously, it can automatically distinguish Xray and output an imaging for diagnosis of disease, injury, or of any applicable health problem.
| Item | Predicate Device:
Wireless Digital Flat Panel
Detector | Proposed Device:
Wireless Digital Flat Panel
Detector | | |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K)
Number | K161730 | To be assigned | | |
| Intended Use | The Mars1417V-PSI
Wireless Digital Flat Panel
Detector is indicated for
digital imaging solution
designed for providing
general radiographic
system in all general
purpose diagnostic
procedures. | Same | | |
| Classification
Name | Stationary X-ray system | Same | | |
| Product Code | MQB | Same | | |
| Regulation
Number | 21 CFR 892.1680 | Same | | |
| | Predicate Device: | Proposed Device: | | |
| Item | Wireless Digital Flat Panel
Detector | Wireless Digital Flat Panel
Detector | | |
| Panel: | Radiology | Same | | |
| Classification: | II | Same | | |
| X-Ray Absorber
(Scintillator): | Gd2O2S | Same | | |
| Installation Type: | Wireless, Portable | Same | | |
| Readout
Mechanism: | Thin Film Transistor | Same | | |
| Image Matrix
Size: | 2304 × 2800 pixels | 2336× 2836 pixels | | |
| Pixel Pitch: | 150μm | Same | | |
| ADC Digitization | 14 bit | 16 bit | | |
| Effective
Imaging Area: | 355 mm × 434 mm | 350.4 mm × 425.4 mm | | |
| Spatial
Resolution: | Min. 3.4lp/mm | Min. 3.3lp/mm | | |
| Modulation
Transfer
Function
(MTF) | 0.75 at 0.5lp/mm | 0.84 at 1 lp/mm | | |
| Detective
Quantum
Efficiency
(DQE) | 0.27 at 0.5 lp/mm (RQA5,
3.2μGy) | 0.43 at 1 lp/mm (RQA5,
2.5μGy) | | |
| Power
Consumption: | Max. 13W | Max. 19W | | |
| Item | Predicate Device:
Wireless Digital Flat Panel
Detector | Proposed Device:
Wireless Digital Flat Panel
Detector | | |
| Communications: | Wired: Gigabit Ethernet
(1000BASE-T)
Wireless: IEEE
802.11a/b/g/n (2.4 GHz / 5 GHz) | Wireless: IEEE
802.11a/b/g/n (2.4 GHz / 5 GHz) | | |
| | Imaging protect
Plate: | Carbon Fiber Plate | Same | |
| | Cooling: | Air cooling | Same | |
| Dimensions: | 384 mm × 460 mm × 15 mm | Same | | |
| Operation: | Temperature: +5 ~ +35°C
Humidity: 30 ~ 75%
(Non-Condensing)
Atmospheric pressure: 70 ~ 106 kPa
Altitude: Max. 3000 meters | Temperature: +5 ~ +30°C
Humidity: 10 ~ 80%
(Non-Condensing)
Atmospheric pressure: 70 ~ 106 kPa
Altitude: Max. 3000 meters | | |
| | Storage and
Transportation:
(detector) | Temperature: -20 ~ +55°C
Humidity: 10 ~ 90%
(Non-Condensing)
Atmospheric pressure: 70 ~ 106 kPa
Altitude: Max. 3000 meters | Temperature: -20 ~ +50°C
Humidity: 10 ~ 90%
(Non-Condensing)
Atmospheric pressure: 70 ~ 106 kPa
Altitude: Max. 3000 meters | |
| | | Software | iRay DR
The iRay DR used for
getting Digital X -ray | iRay SDK(include
iDetector) is intend to
supply API interface for |
| | | Item | Predicate Device:
Wireless Digital Flat Panel
Detector | Proposed Device:
Wireless Digital Flat Panel
Detector |
| | | | radiography images from
the flat panel detectors.
iRay DR is used to handle
the DICOM protocol
(DICOM 3.0),
iRay DR 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. | 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. |
7. Technological Characteristic [21 CFR 807.92(a)(6)]
6
[510(k)] Application
7
[510(k)] Application
8
[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 your distributor or iRay's service office.
-
- Application Program Interface (API) for system integration manufacturer Peripheral hardware: Mars1417XF-GSI detector connected via wireless communication.
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9
K182550
[510(k)] Application
iRay Technology Taicang Ltd.
| Operating System: | Windows XP/7 32/64bit |
|---|---|
| CPU: | Intel Core i5 3.6G |
| Memory: | 8G DDR3 |
| Hard Disk: | 640 G |
| LAN Card: | Intel Pro EXP9301CT PRO |
| Gigabit Network Adapter with PCIe interface |
3) X-ray exposure mode
The AED trigger module is a unit can connect X-ray signal in the Mars1417XF-GSI. Once there is X-ray generator exposure exist, the inner 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. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)]
-
- Electrical Safety and EMC testing:
Electrical, mechanical, environmental safety and performance testing 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.
- Electrical Safety and EMC testing:
-
- Biological Evaluation:
The materials of the detector which contact operators' or patient's skin have been evaluated with the ISO 10993-1. And the evaluation results and test result assured the safety the same as the predicate device.
- Biological Evaluation:
-
- Nonclinical Considerations:
The non-clinical studies have been performed and the results have shown that the Mars1417XF-GSI wireless digital X-ray flat panel detector is substantially equivalent to the predicate devices on the Market (Mars1417V-PSI, K161730 ): Detective quantum efficiency (DQE), Quantum limited performance, Modulation transfer function (MTF), Effects of aliasing, Sensitivity linearity, Lag, Change in detection sensitivity, Dose requirement and reciprocity changes, Stability of device
- Nonclinical Considerations:
10
[510(k)] Application
characteristics with time, Uniformity of device characteristic, Noise power spectrum(NPS), Spatial resolution, Image Acquisition time, and Black level. According to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, the software SDK classifies the hazards, defines requirements specification and design specification, all the specification pass the 16 test cases and complies the intended design specification.
4) Clinical Consideration:
Nonclinical information of Mars1417XF-GSI is sufficient to support the substantial equivalence of a subject to a predicate device (Mars1417V-PSI, K161730 ) for its modifications without the need to provide additional clinical data. The only change for the Mars1417XF-GSI is in the ADC Digitization and software. And for the communication function, the Mars1417XF-GSI reduce the wired communication function.
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, iRay Technology Taicang Ltd. Concludes that iRay Mars1417XF-GSI Wireless Digital Flat Panel Detectors is substantially equivalent to predicate device with regards to safety and effectiveness.