(30 days)
Not Found
No
The summary describes a standard digital X-ray detector and its image processing functions, but there is no mention of AI or ML being used for image analysis, interpretation, or any other function.
No
This device is a digital flat panel detector used for capturing radiographic images, not for treating diseases or conditions.
Yes.
The device is indicated for "general radiographic diagnosis of human anatomy," which directly refers to its use in diagnosing medical conditions through imaging.
No
The device is described as a "Wireless Digital Flat Panel Detector" and includes physical components like a TFT/PD image sensor flat panel, CsI scintillator, diode capacitor array, and scanning/readout electronics, indicating it is a hardware device with associated 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 it's for "general radiographic diagnosis of human anatomy" and is intended to "replace radiographic film/screen systems." This describes an imaging device used to capture images of the body, not a device used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body.
- Device Description: The description focuses on the conversion of X-rays to digital images and its role as a component in a DR system for medical X-ray imaging. This aligns with an imaging device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting specific analytes, or providing diagnostic information based on the analysis of specimens.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to capture images of the internal structure of the body using X-rays.
N/A
Intended Use / Indications for Use
Mars1417XF-CSI 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 (comma separated list FDA assigned to the subject device)
MQB
Device Description
Mars1417XF-CSI 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-CSI Wireless Digital Flat Panel 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 Mars1417XF-CSI 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)
Clinical Consideration:
A concurrence study of 30 images was conducted to compare the performance of the Mars1417XF-CSI to that of the predicate device (Mars1417V-PSI, K161730 ). Phantom images were provided; these images were not necessary to establish substantial equivalence based on the differences from the predicate but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended.
There was no significant difference between the images of the Mars1417XF-CSI and those of the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
Re: K182551
Trade/Device Name: Wireless Digital Flat Panel Detector Mars 1417XF-CSI 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.
October 17, 2018
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. O'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)
Device Name
Wireless Digital Flat Panel Detector
Indications for Use (Describe)
Mars1417XF-CSI 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) | ||
|---|---|---|---|
| --------------------------------------------------- | ------------------------------------------------------------------------------------------------- | --------------------------------------------------- | ----------------------------------------------- |
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.
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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) 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-CSI |
| 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: iRay Technology Co.,Ltd. Manufacturer:
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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-CSI 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-CSI Wireless Digital Flat Panel Detector is directdeposited 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 Mars1417XF-CSI 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-CSI 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.
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[510(k)] Application
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[510(k)] Application
iRay Technology Taicang Ltd.
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 | | |
| Item | Predicate Device:
Wireless Digital Flat
Panel Detector | Proposed Device:
Wireless Digital Flat
Panel Detector | | |
| Regulation
Number | 21 CFR 892.1680 | Same | | |
| Panel: | Radiology | Same | | |
| Classification: | II | Same | | |
| X-Ray Absorber
(Scintillator): | Gd2O2S | CsI | | |
| 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) | 0.48 at 1 lp/mm | 0.5 at 1 lp/mm | | |
| Detective
Quantum
Efficiency
(DQE) | 0.20 at 1 lp/mm (RQA5,
3.2µGy) | 0.37 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: | $384 \text{ mm } \times 460 \text{ mm } \times 15 \text{ mm}$ | 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 | |
| | | Item | Predicate Device: | Proposed Device: |
| | | | Wireless Digital Flat | Wireless Digital Flat |
| | | | Panel Detector | Panel Detector |
| | | Software | iRay DR
The iRay DR used for
getting Digital X -ray
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. | iRay SDK(include
iDetector) 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. |
7. Technological Characteristic [21 CFR 807.92(a)(6)]
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iRay Technology Taicang Ltd.
[510(k)] Application
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iRay Technology Taicang Ltd.
[510(k)] Application
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iRay Technology Taicang Ltd.
[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
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[510(k)] Application
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-CSI detector connected via wireless communication.
| 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 |
-
- X-ray exposure mode
The AED trigger module is a unit can connect X-ray signal in the Mars1417XF-CSI. 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.
- X-ray exposure mode
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:
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[510(k)] Application
The non-clinical studies have been performed and the results have shown that the Mars1417XF-CSI 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 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:
A concurrence study of 30 images was conducted to compare the performance of the Mars1417XF-CSI to that of the predicate device (Mars1417V-PSI, K161730 ). Phantom images were provided; these images were not necessary to establish substantial equivalence based on the differences from the predicate but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended.
There was no significant difference between the images of the Mars1417XF-CSI and those of the predicate device.
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-CSI Wireless Digital Flat Panel Detectors is substantially equivalent to predicate device with regards to safety and effectiveness.