(15 days)
Not Found
No
The summary describes a standard digital flat panel X-ray detector and its components. There is no mention of AI, ML, or any advanced image processing beyond basic signal conversion and composition.
No
The device is described as a "digital imaging solution" for "general radiographic diagnosis" and is intended to "replace film/screen systems," indicating its use for diagnostic imaging rather than therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices "are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy."
No
The device description clearly states it is a wireless digital flat panel detector, which is a hardware component that converts X-rays to digital images. While it includes software (iRay SDK), the core device is hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "digital imaging solutions designed to provide general radiographic diagnosis for human anatomy". This involves capturing images of the internal structure of the body using X-rays.
- Device Description: The device is a "wireless digital flat panel detector" that converts X-rays into digital images.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device is a medical imaging device used for diagnostic purposes, but it falls under the category of radiology equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Mars1417V-TSI wireless digital flat panel detector and Mano4336W wireless digital flat panel 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 device is not intended for mammography or dental applications.
Product codes
MQB
Device Description
Mars1417V-TSI and Mano4336W Wireless Digital Flat Panel Detectors (Hereinafter referred to as Mars1417V-TSI and Mano4336W) 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: 34.56cm×42.00cm. Mars1417V-TSI and Mano4336W are totally same except for label and model name.
The sensor plate of Mars1417V-TSI and Mano4336W 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 Mars1417V-TSI and Mano4336W 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 intend to be used directly by other users beside DR system manufacturers.
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 explicitly stated, but implies use by DR system manufacturers and medical professionals for general radiographic diagnosis.
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)
Non-clinical studies were performed to assess electrical safety, EMC, and biological evaluation according to IEC/ES 60601-1, IEC 60601-1-2, and ISO 10993-1. The results met standard requirements and showed safety. Non-clinical studies also confirmed substantial equivalence to the predicate device regarding non-clinical considerations mentioned in the 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices', despite modifications in geometric design (Amorphous Silicon (A-Si) panel size) and wireless functionality (predicate device has higher wireless transmission speed).
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
May 1, 2020
Image /page/0/Picture/1 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA, featuring a stylized caduceus. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
iRay Technology Taicang Ltd. % Meng Li Registration & Regulation Affairs Engineer No. 33 Xinggang Rd., Taicang Port Economic & Technological Development Zone Taicang, Jiangsu 215434 CHINA
Re: K201004
Trade/Device Name: Wireless Digital Flat Panel Detector (Models, Mars1417V-TSI, Mano4336W) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: April 10, 2020 Received: April 23, 2020
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 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 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
1
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
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)
Mars 1417V-TSI wireless digital flat panel detector and Mano436W wireless digital flat panel 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 device is 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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3
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
(As Required by 21 CFR 807.92)
-
- Date Prepared [21 CFR 807.92(a)(1)]
April 29th, 2020
- Date Prepared [21 CFR 807.92(a)(1)]
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@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: | Mars1417V-TSI |
| Mano4336W | |
| Classification Name: | Stationary X-Ray System |
| Product Code: | MQB |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |
4
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: | Mars1417XF-CSI |
| Product Code: | MQB |
| Classification Name: | Stationary X-Ray System |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |
| FDA 510 (k) #: | K182551 |
5. Description of the Device [21 CFR 807.92(a)(4)]
Mars1417V-TSI and Mano4336W Wireless Digital Flat Panel Detectors (Hereinafter referred to as Mars1417V-TSI and Mano4336W) 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: 34.56cm×42.00cm. Mars1417V-TSI and Mano4336W are totally same except for label and model name.
The sensor plate of Mars1417V-TSI and Mano4336W 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 Mars1417V-TSI and Mano4336W 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 intend to be used directly by other users beside DR system manufacturers.
5
6. Intended Use [21 CFR 807.92(a)(5)]
6.1. Indications for use
Mars1417V-TSI wireless digital flat panel detector and Mano4336W wireless digital flat panel 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 device is not intended for mammography or dental applications.
6.2. Suitable patient
It is 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: | Proposed Device: |
|---|---|---|
| Wireless Digital Flat Panel | ||
| Detector | Wireless Digital Flat Panel | |
| Detector | ||
| 510(K) Number | K182551 | To be assigned |
| Intended Use | The Mars1417XF-CSI | |
| Wireless Digital Flat Panel | ||
| Detector is indicated for digital | ||
| imaging solution designed for | ||
| providing general radiographic | same | |
| Predicate Device: | Proposed Device: | |
| Item | Wireless Digital Flat Panel | |
| Detector | Wireless Digital Flat Panel | |
| Detector | ||
| Indications for | ||
| Use | system in all general-purpose | |
| diagnostic procedures. | ||
| The Mars1417XF-CSI | ||
| Wireless Digital Flat Panel | ||
| Detector is indicated for digital | ||
| imaging solution designed for | ||
| providing general radiographic | ||
| diagnosis of human anatomy. | ||
| 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/ | ||
| downloads/MedicalDevices/Re | ||
| sourcesforYou/Industry/UCM3 | ||
| 85149.pdf ). | ||
| Below is a summary of the | ||
| information from the | ||
| Mars1417XF-CSI user | ||
| manuals covering key | ||
| electromechanical | Same with Mars1417XF-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 | ||
| both adults and pediatric | ||
| patients. | ||
| Item | Predicate Device: | Proposed Device: |
| Wireless Digital Flat Panel | ||
| Detector | Wireless Digital Flat Panel | |
| Detector | ||
| 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 Mars1417XF-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. | |
| Classification
Name | Stationary X-ray system | Same |
| Product Code | MQB | Same |
| Regulation
Number | 21 CFR 892.1680 | Same |
| Panel: | Radiology | Same |
| | Predicate Device:
Wireless Digital Flat Panel
Detector | Proposed Device:
Wireless Digital Flat Panel
Detector |
| Item | | |
| Classification: | II | Same |
| X-Ray Absorber
(Scintillator): | CsI | Same |
| Installation Type: | Wireless, Portable | Same |
| Readout
Mechanism: | Thin Film Transistor | Same |
| Image Matrix
Size: | 2336× 2836 pixels | 2304 × 2800 pixels |
| Pixel Pitch: | 150μm | Same |
| ADC Digitization | 16 bit | Same |
| Effective Imaging
Area: | 350.4 mm × 425.4 mm | 345.6 mm × 420.0 mm |
| Spatial
Resolution: | Min. 3.3lp/mm | Same |
| Modulation
Transfer
Function
(MTF) | 0.5 at 1 lp/mm | 0.68 at 1 lp/mm |
| Detective
Quantum
Efficiency
(DQE) | 0.37 at 1 lp/mm (RQA5,
2.5µGy) | 0.36 at 1 lp/mm (RQA5,
2.5µGy) |
| Power
Consumption: | Max. 19W | Max. 18W |
| Item | Predicate Device:
Wireless Digital Flat Panel
Detector | Proposed Device:
Wireless Digital Flat Panel
Detector |
| Communications:
(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: | 384 mm × 460 mm × 15 mm | Same |
| Operation: | Temperature: +5 ~ +30°C
Humidity: 10 ~ 80%
(Non-Condensing)
Atmospheric pressure: 70 ~
106 kPa
Altitude: Max. 3000 meters | Temperature: +5 ~ +35°C
Humidity: 10 ~ 90%
(Non-Condensing)
Atmospheric pressure: 70 ~ 106
kPa
Altitude: Max. 3000 meters |
| Storage and
Transportation:
( detector ) | Temperature: -20 ~ +50°C
Humidity: 10 ~ 90%
(Non-Condensing)
Atmospheric pressure: 70 ~
106 kPa
Altitude: Max. 3000 meters | Temperature: -20 ~ +55°C
Humidity: 5 ~ 95%
(Non-Condensing)
Atmospheric pressure: 70 ~ 106
kPa
Altitude: Max. 3000 meters |
| Software | iRay SDK(include iDetector) is
intend to supply API interface
for DR system manufacturers.
DR system manufacturer | Same |
| | Predicate Device: | Proposed Device: |
| Item | Wireless Digital Flat Panel
Detector | Wireless Digital Flat Panel
Detector |
| | control the detector by SDK
interface. SDK is not intend to
use directly by other users
beside DR system
manufacturers. | |
| 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 Mars1417XF-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)]
6
7
8
9
10
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)
11
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 iRay's service office.
-
- Application Program Interface (API) for system integration manufacturer Peripheral hardware: Mars1417V-TSI and Mano4336W connected via wireless communication.
| Operating System: | Windows 7 32/64bit |
|---|---|
| CPU: | Intel Core i7 3.6G |
| Memory: | 4G 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 Mars1417V-TSI/Mano4336W. 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. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)|
-
- 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:
12
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 Mars1417V-TSI and Mano4336W is geometric design, related to Amorphous Silicon (A-Si) panel size. Another modification is wireless functionality, predicate 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 (Mars1417XF-CSI, K182551).
-
- 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 dimensions of the image receptor with otherwise identical materials if non-clinical information is sufficient to support the substantial equivalence.
- Clinical Consideration:
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 Mars1417V-TSI and Mano4336W are substantially equivalent to predicate device with regards to safety and effectiveness.