(30 days)
No
The description focuses on the hardware components and basic image processing for converting X-ray to a digital image. There is no mention of AI, ML, or advanced algorithms for image analysis or interpretation.
No
This device is a digital flat panel detector that converts X-rays into digital images for diagnostic purposes, not for providing therapy.
Yes
The "Intended Use / Indications for Use" states that the device is "indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy." This clearly indicates its role in diagnosis.
No
The device description clearly outlines hardware components like a TFT/PD image sensor, scintillator, scanning and readout electronics, and a physical flat panel detector, 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:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Mars 1717XF-GSI Wireless Digital Flat Panel Detector is an imaging device that converts X-rays to digital images for general radiographic diagnosis of human anatomy. It works by capturing X-rays that pass through the body, not by analyzing samples taken from the body.
- Intended Use: The intended use is for "general radiographic diagnosis of human anatomy," which is a form of medical imaging, not in vitro testing.
Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Mars 1717XF-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, Additionally, it is not intended for mammography, dental applications, pediatric, pregnant women and fluoroscopy.
Product codes
MQB
Device Description
Mars1717XF-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 (Thin Film Transistor)/PD (Photo Diode) image sensor flat panel of active area: 42.48cm×42.54cm.
The sensor plate of Mars1717XF-GSI Wireless Digital Flat Panel Detector is coated with Gd2O2S (GOS) 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 Mars1717XF-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
Adult
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 and performance testing according to IEC/ES 60601-1 was performed, and EMC testing was also conducted in accordance with IEC/EN 60601-1-2. All test results are meet standard requirements.
- Biological Evaluation: The materials of the detector which contact operators' 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: The only modification from the predicate device to Mars1717XF-GSI is the panel dimension, related to Amorphous Silicon (A-Si) panel size and structure size design. 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-GSI, K182550).
- Clinical Consideration: The only modification from the predicate device to Mars1717XF-GSI is the panel dimension, related to Amorphous Silicon (a-Si) panel size and structure size design. 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, which is described details in '009 Substantial Equivalence Discussion' in this submission.
There was no significant difference between the images of the Mars1717XF-GSI 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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features 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 & Regulation Affairs Engineer No. 33 Xinggang Rd., Taicang Port Economic & Technological Development Zone Taicang, Jiangsu 215434 CHINA
Re: K183422
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: November 1, 2018 Received: December 10, 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
January 9, 2019
1
requirements, including, but not limited to: registration and listing (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 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K183422
Device Name Wireless Digital Flat Panel Detector
Indications for Use (Describe)
Mars 1717XF-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,
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/ResourcesforYou/Industry/UCM385149.pdf ).
Below is a summary of the information from the Mars1717XF-GSI 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-GSI 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.
| 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)
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! *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
(As Required by 21 CFR 807.92)
1. Date Prepared [21 CFR 807.92(a)(1)]
November 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@iraygroup.com |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| 510(k) Number: | K183422 |
|---|---|
| Trade Name: | Wireless Digital Flat Panel Detector |
| Common Name: | Solid State X-Ray Imager |
| Model Name: | Mars1717XF-GSI |
| Classification Name: | Stationary X-Ray System |
| Product Code: | MQB |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |
SECTION 6 - 2 of 12
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-GSI |
| Product Code: | MQB |
| Classification Name: | Stationary X-Ray System |
| FDA 510 (k) #: | K182550 |
5. Description of the Device [21 CFR 807.92(a)(4)]
Mars1717XF-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 (Thin Film Transistor)/PD (Photo Diode) image sensor flat panel of active area: 42.48cm×42.54cm.
The sensor plate of Mars1717XF-GSI Wireless Digital Flat Panel Detector is coated with Gd2O2S (GOS) 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 Mars1717XF-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
Mars1717XF-GSI Wireless Digital Flat Panel Detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human
SECTION 6 - 3 of 12
5
anatomy. It is intended to replace radiographic film/screen systems in all generalpurpose diagnostic procedures. This device is not intended for mammography, dental applications, pediatric, pregnant women and fluoroscopy.
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 | K182550 | To be assigned |
| Intended Use | The Mars1417XF-GSI Wireless
Digital Flat Panel Detector is
indicated for digital imaging
solution designed for providing
general radiographic system in all
general purpose diagnostic
procedures. | Same with
Mars1417XF-
GSI,
additionally, it is
not intended for
mammography,
dental |
| | Predicate Device: | Proposed
Device: |
| Item | Wireless Digital Flat Panel
Detector | Wireless Digital
Flat Panel
Detector |
| 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.
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/dow
nloads/MedicalDevices/Resourcesf
orYou/Industry/UCM385149.pdf). | applications,
pediatric,
pregnant women
and fluoroscopy.
Same with
Mars1417XF-
GSI,
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 adult. |
| Item | Predicate Device: | Proposed
Device: |
| | Wireless Digital Flat Panel
Detector | Wireless Digital
Flat Panel
Detector |
| | Below is a summary of the
information from the Mars1417XF-
GSI 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 Mars1417XF-GSI
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 |
| Item | Predicate Device:
Wireless Digital Flat Panel
Detector | Proposed Device:
Wireless Digital
Flat Panel
Detector |
| Product Code | MQB | Same |
| Regulation Number | 21 CFR 892.1680 | Same |
| Panel: | Radiology | Same |
| Classification: | II | Same |
| X-Ray Absorber
(Scintillator): | Gd2O2S (GOS) | Same |
| Installation Type: | Wireless, Portable | Same |
| Readout Mechanism: | Thin Film Transistor | Same |
| Image Matrix Size: | 2336 × 2836 pixels | 2832× 2836 pixels |
| Pixel Pitch: | 150μm | Same |
| ADC Digitization | 16 bit | Same |
| Effective Imaging Area: | 350.4 mm × 425.4 mm | 424.8 mm × 425.4 mm |
| Spatial Resolution: | Min. 3.3lp/mm | Same |
| Modulation Transfer Function (MTF) | 0.45 at 1 lp/mm | 0.44 at 1 lp/mm |
| Detective Quantum Efficiency | 0.22 at 1 lp/mm | 0.23 at 1 lp/mm |
| Item
(DQE) | Predicate Device:
Wireless Digital Flat Panel
Detector | Proposed
Device:
Wireless Digital
Flat Panel
Detector |
| (RQA5, 3.2µGy) | | |
| Power
Consumption: | Max. 19W | Max. 20W |
| Communications:
(Wireless
functionality) | Wireless: IEEE 802.11a/b/g/n (2.4
GHz / 5 GHz) | Same |
| Communications: | Wireless: IEEE 802.11a/b/g/n (2.4
GHz / 5 GHz) | Same |
| Imaging
protect
Plate: | Carbon Fiber Plate | Same |
| Cooling: | Air cooling | Same |
| Dimensions: | 384 mm × 460 mm × 15 mm | 460 mm × 460
mm×15 mm |
| Operation:
Storage and | Temperature: +5 ~ +30 ℃
Humidity: 10 ~ 80%
(Non-Condensing)
Atmospheric pressure: 70 ~ 106
kPa
Altitude: Max. 3000 meters | Same |
| Transportation:
( detector ) | Temperature: -20 ~ +50 ℃
Humidity: 10 ~ 90%
(Non-Condensing) | Same |
| Item | Predicate Device: | Proposed
Device: |
| | Wireless Digital Flat Panel
Detector | Wireless Digital
Flat Panel
Detector |
| | 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 control the
detector by SDK interface. SDK is
not intend 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 |
7. Technological Characteristic [21 CFR 807.92(a)(6)]
SECTION 6 - 4 of 12
6
SECTION 6 - 5 of 12
7
SECTION 6 - 6 of 12
8
SECTION 6 - 7 of 12
9
SECTION 6 - 8 of 12
10
SECTION 6 - 9 of 12
11
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 still having 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: Mars1717XF-GSI 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 |
3) X-ray exposure mode
The AED trigger module is a unit can connect X-ray signal in the Mars1717XF-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: 1)
SECTION 6 - 10 of 12
12
iRay Technology Taicang Ltd.
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/EN 60601-1-2. All test results are meet standard requirements.
-
- Biological Evaluation:
The materials of the detector which contact operators' 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:
The only modification from the predicate device to Mars1717XF-GSI is the panel dimension, related to Amorphous Silicon (A-Si) panel size and structure size design. 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-GSI, K182550).
- Non-clinical Considerations:
-
- Clinical Consideration:
The only modification from the predicate device to Mars1717XF-GSI is the panel dimension, related to Amorphous Silicon (a-Si) panel size and structure size design. 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, which is described details in '009 Substantial Equivalence Discussion' in this submission.
- Clinical Consideration:
There was no significant difference between the images of the Mars1717XF-GSI and those of the predicate device.
-
- Conclusion [21 CFR 807.92(b)(3)]
SECTION 6 - 11 of 12
13
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 Mars1717XF-GSI Wireless Digital Flat Panel Detectors is substantially equivalent to predicate device with regards to safety and effectiveness.