(22 days)
Not Found
No
The description focuses on the hardware components and basic image processing (conversion of X-ray to digital image) without mentioning any AI/ML algorithms for image analysis, interpretation, or enhancement beyond standard processing.
No
The device is described as being for "digital imaging solutions designed to provide general radiographic diagnosis," and its function is to "convert the X-ray to digital image." It is used for diagnosis, not treatment.
Yes
The "Intended Use / Indications for Use" section states that the devices "are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy". This explicitly indicates that the device is used for diagnostic purposes.
No
The device description clearly states that the device is a "Wireless Digital Flat Panel Detector" and describes its physical components (TFT/PD image sensor, CsI scintillator, diode capacitor array, scanning and readout electronics). This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "digital imaging solutions designed to provide general radiographic diagnosis for human anatomy". This describes an imaging device used to visualize internal structures of the body, not a device used to examine specimens derived from the human body (like blood, urine, or tissue) in vitro (outside the body).
- Device Description: The description details how the device converts X-rays into digital images. This is consistent with an imaging device, not an IVD.
- Input Imaging Modality: The input modality is X-ray, which is a form of medical imaging, not a method used for in vitro diagnostic testing.
- Anatomical Site: The device is used on "human anatomy", indicating it is applied directly to the patient for imaging.
IVD devices are specifically designed to perform tests on samples taken from the body to provide information about a person's health. This device's function is to capture images of the body using X-rays.
N/A
Intended Use / Indications for Use
Wireless Digital Flat Panel Detector (Model:Mars1717V-VSI, Mano4343W) are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatic patients. They are intended to replace film/screen systems in all general-purpose diagnostic procedures. These two devices are not intended for mammography, dental applications.
Product codes
MQB
Device Description
Mars1717V-VSI and Mano4343W Wireless Digital Panel Detectors (Hereinafter referred to as Mars1717V-VSI and Mano4343W) are the kind of wireless digital flat panel detectors. They support the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 427mm x 427mm. Two models Mars1717V-VSI and Mano4343W are totally same except for label and model name. The sensor plate of Mars1717V-VSI and Mano4343W 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 Mars1717V-VSI and Mano4343W 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, enable to complete the digitalization of the medical X-ray imaging with the DR system software.
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 intended to be used directly by other users beside DR system manufacturers. The iRay SDK is unchanged from the predicate device.
Mentions image processing
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.
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 test 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 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. -
Non-clinical Considerations:
One modification from the predicate device to Mars1717V-VSI and Mano4343W is geometric design, related to Amorphous Silicon (A-Si) panel size and structure size design. Another modification is wireless functionality, proposed device has higher wireless transmission speed.
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-consideration of predicate devices on the Market (Mars1717XF-CSI, K183713).
- Clinical Consideration:
Intended use, fundamental scientific technology, regulatory requirement, non-clinical performance, labeling, quality-assurance program and software keep the same with those of predicate device. Additionally, as mentioned in clinical considerations in 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices', clinical consideration may not necessary for changes in the pixel size and resolution with the same x-ray detection material and may not necessary for changes in the wireless functionality if non-clinical information is sufficient to support the substantial equivalence.
There was no significant difference between the images of the Mars1717V-VSI/Mano4343W and those of the predicate device.
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 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 logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 12, 2020
iRay Technology Taicang Ltd. % Mr. Junjie Qian Registration & Regulation Affairs Engineer No. 33 Xinggang Rd., Taicang Port Economic & Technological Development Zone Taicang, Jiangsu 215434 CHINA
Re: K201043
Trade/Device Name: Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: April 8, 2020 Received: April 20, 2020
Dear Mr. 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 (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 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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/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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/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-regulatoryassistance/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,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201043
Device Name
Wireless Digital Flat Panel Detector (Model:Mars1717V-VSI, Mano4343W)
Indications for Use (Describe)
Wireless Digital Flat Panel Detector (Model:Mars1717V-VSI, Mano4343W) are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatic patients. They are intended to replace film/screen systems in all general-purpose diagnostic procedures. These two devices are not intended for mammography, dental applications.
There are no differences between the 2 models except the model name and label.
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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3
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
K201043
SECTION 6 - 1 of 12
4
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
(As Required by 21 CFR 807.92)
1. Date Prepared [21 CFR 807.92(a)(1)]
April 8th, 2020
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: | Junjie Qian |
| Phone: | 0512-53690872 |
| Fax: | 0512-53690872 |
| Email: | junjie.qian@iraygroup.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: | Mars1717V-VSI |
| Mano4343W | |
| 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: | iRay Technology Taicang Ltd. |
|---|---|
| Trade Name: | Wireless Digital Flat Panel Detector |
| Model Name: | Mars1717XF-CSI |
| Product Code: | MQB |
| Device Class: | Class II |
| Classification Name: | Stationary x-ray system |
| FDA 510 (k) #: | K183713 |
5. Description of the Device [21 CFR 807.92(a)(4)]
Mars1717V-VSI and Mano4343W Wireless Digital Panel Detectors (Hereinafter referred to as Mars1717V-VSI and Mano4343W) are the kind of wireless digital flat panel detectors. They support the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 427mm x 427mm. Two models Mars1717V-VSI and Mano4343W are totally same except for label and model name. The sensor plate of Mars1717V-VSI and Mano4343W 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 Mars1717V-VSI and Mano4343W 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, enable to complete the digitalization of the medical X-ray imaging with the DR system software.
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 intended to be used directly by other users beside DR system manufacturers. The iRay SDK is unchanged from the predicate device.
SECTION 6 - 3 of 12
6
6. Intended Use [21 CFR 807.92(a)(5)]
6.1. Indications for use
Mars1717V-VSI and Mano4343W 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. These two devices are not intended for mammography, dental applications. There are no differences between the 2 models except the model name and label.
6.2. Suitable patient
They are suitable for providing digital X-ray 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 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 | K183713 | K201043 |
| Intended Use | The Mars1717XF-CSI Wireless
Digital Flat Panel Detector is
indicated for digital imaging | same |
| Item | Predicate Device:
Wireless Digital Flat Panel
Detector | Proposed Device:
Wireless Digital Flat Panel
Detector |
| | solution designed for providing
general radiographic system in all
general-purpose diagnostic
procedures. | |
| Indications for
Use | Mars1717XF-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.
We understand the Agency has
become aware of situations where
solid state detectors inserted into
radiographic systems adversely
impacted device performance due
to improper integration
(reference:http://www.fda.gov/do
wnloads/MedicalDevices/Resourc | Same with Mars1717XF-CSI,
additionally, in the
consideration of patient size
(i.e., height, weight, body part
thickness) and usable dose
range, the detector could be
used for general X ray
diagnosis of usual body part
for adults and pediatric
patients.
. |
| Item | Predicate Device: | Proposed Device: |
| | Wireless Digital Flat Panel
Detector | Wireless Digital Flat Panel
Detector |
| | esforYou/Industry/UCM385149.pdf). | |
| | Below is a summary of the
information from the
Mars1717XF-CSI user manuals
covering key electromechanical
and computer requirements
needed for X-ray system interface
and integration.
- Mechanical interface
requirements. - Computer requirements
- Data communication interface
requirements - Electrical power requirements
- X-ray trigger interface
requirements | |
| | Neither the Mars1717XF-CSI
detector nor its software act as an
X-ray generator controller, and
therefore, the device is not subject
to Electronic Product Radiation
Control (EPRC) performance
standards and reporting
requirements. | |
| | Predicate Device: | Proposed Device: |
| Item | Wireless Digital Flat Panel
Detector | Wireless Digital Flat Panel
Detector |
| Classification
Name | Stationary x-ray system | Same |
| Product Code | MQB | Same |
| Regulation
Number | 21 CFR 892.1680 | Same |
| Panel: | Radiology | Same |
| Classification: | II | Same |
| X-Ray Absorber
(Scintillator): | CsI | Same |
| Installation
Type: | Wireless, Portable | Same |
| Readout
Mechanism: | Thin Film Transistor | Same |
| Image Matrix
Size: | 2832×2836 pixels | 3072 ×3072 pixels |
| Pixel Pitch: | 150μm | 139μm |
| ADC
Digitization | 16 bit | Same |
| Effective
Imaging Area: | 424.8 mm × 425.4 mm | 427 mm x 427 mm |
| Spatial
Resolution: | 3.3lp/mm | 3.6lp/mm |
| Modulation
Transfer
Function
(MTF) | 0.49 at 1 lp/mm | 0.65 at 1 lp/mm |
| | Predicate Device: | Proposed Device: |
| Item | Wireless Digital Flat Panel
Detector | Wireless Digital Flat Panel
Detector |
| Detective
Quantum
Efficiency
(DQE) | $0.40 \text{ at } 1 \text{ lp/mm (RQA5, } 2.5\mu\text{Gy)}$ | Same |
| Power
Consumption: | Max. 20W | Max. 30W |
| Communication
s:
(Wireless
functionality) | Wireless: IEEE 802.11a/b/g/n (2.4 GHz / 5 GHz) | a) Wired (only for service) : Gigabit
Ethernet (1000BASE-T)
b) Wireless: IEEE
802.11a/b/g/n/ac (2.4 GHz / 5 GHz) |
| Imaging protect
Plate: | Carbon Fiber Plate | Same |
| Cooling: | Air cooling | Same |
| Dimensions: | 460 mm × 460 mm × 15 mm | 460 mm × 460 mm × 15.3 mm |
| Operation: | Temperature: +5 ~ +30 °C | Temperature: +5 ~ +35 °C |
| | Humidity: 10 ~ 80%
(Non-Condensing) | Humidity: 5 ~ 95%
(Non-Condensing) |
| | Atmospheric pressure: 70 ~ 106 kPa | Atmospheric pressure: 55 ~ 106 kPa |
| | Altitude: Max. 3000 meters | Altitude: Max. 3000 meters |
| Storage and
Transportation: | Temperature: -20 ~ +50 °C | Temperature: -10 ~ +55 °C |
| | Humidity: 10 ~ 90% | Humidity: 5 ~ 95% |
| Item | Predicate Device:
Wireless Digital Flat Panel
Detector | Proposed Device:
Wireless Digital Flat Panel
Detector |
| ( detector ) | (Non-Condensing)
Atmospheric pressure: 70 ~ 106 kPa
Altitude: Max. 3000 meters | (Non-Condensing)
Atmospheric pressure: 55 ~ 106 kPa
Altitude: Max. 3000 meters |
| Software | 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 intended to use directly by
other users beside DR system
manufacturers. | Same |
| Utilized FDA
guidance
documents | 1. Guidance for the Submission
of 510(k)'s for Solid State X-
ray Imaging Devices; - The 510(k) Program:
Evaluating Substantial
Equivalence in Premarket
Notifications[510(k)]; - Content of Premarket
Submissions for Management
of Cybersecurity in Medical
Devices; - Radio Frequency Wireless
Technology in Medical
Devices. | Same with Mars1717XF-CSI,
additionally: - Guidance for "Premarket
Assessment of Pediatric
Medical Devices"; - Guidance for "Pediatric
Information for X-ray
Imaging Device Premarket
Notifications". |
7. Technological Characteristic [21 CFR 807.92(a)(6)]
SECTION 6 - 4 of 12
7
SECTION 6 - 5 of 12
8
SECTION 6 - 6 of 12
9
iRay Technology Taicang Ltd.
[510(k)] Application
SECTION 6 - 7 of 12
10
iRay Technology Taicang Ltd.
[510(k)] Application
SECTION 6 - 8 of 12
11
SECTION 6 - 9 of 12
12
8. System requirements to operate with other radiographic system components
-
- Recommended Generator Specification:
Energy range: 40~150keV
- 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: Mars1717V-VSI and Mano4343W are connected via wireless communication.
recommended computer hardware requirement is :
- Application Program Interface (API) for system integration manufacturer Peripheral hardware: Mars1717V-VSI and Mano4343W are connected via wireless communication.
-
Windows 7 32/64 bit
-
•Intel Core i7 3.6G
-
•4G DDR3
-
•640 G
-
· 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 Mars1717V-VSI and Mano4343W. 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.
SECTION 6 - 10 of 12
13
9. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)]
-
Electrical Safety and EMC testing: 1)
Electrical, mechanical, environmental safety test 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 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:
-
- Non-clinical Considerations:
One modification from the predicate device to Mars1717V-VSI and Mano4343W is geometric design, related to Amorphous Silicon (A-Si) panel size and structure size design. Another modification is wireless functionality, proposed device has higher wireless transmission speed.
- 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-consideration of predicate devices on the Market (Mars1717XF-CSI, K183713).
-
- Clinical Consideration:
Intended use, fundamental scientific technology, regulatory requirement, non-clinical performance, labeling, quality-assurance program and software keep the same with those of predicate device. Additionally, as mentioned in clinical considerations in 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices', clinical consideration may not necessary for changes in the pixel size and resolution with the same x-ray detection material and may not necessary for changes in the wireless functionality if non-clinical information is sufficient to support the substantial equivalence.
- Clinical Consideration:
There was no significant difference between the images of the Mars1717V-VSI/Mano4343W and those of the predicate device.
SECTION 6 - 11 of 12
14
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 Mars1717V-VSI and Mano4343W are substantially equivalent to predicate device with regards to safety and effectiveness.