(25 days)
No
The description focuses on the hardware and basic image processing for converting X-ray signals to digital images. There is no mention of AI, ML, or advanced image analysis beyond basic signal processing.
No.
The device is a digital flat panel detector used for general radiographic diagnosis, converting X-rays into digital images; it does not directly treat or restore health.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy." This clearly identifies it as a diagnostic device.
No
The device description clearly details hardware components like a TFT/PD image sensor flat panel, CsI scintillator, scanning and readout electronics, and a physical detector that converts X-rays to digital images. While it mentions software (iRay SDK) used by manufacturers to control the detector, the core medical device is a physical flat panel detector.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring or compatibility purposes.
- Device Function: The Mars1013X Wireless Digital Flat Panel Detector is an imaging device that converts X-rays into digital images of the human anatomy. It is used in vivo (within the living body) to capture images for diagnostic purposes.
- Intended Use: The intended use clearly states it's for "digital imaging solutions designed to provide general radiographic diagnosis for human anatomy". This involves capturing images of the body itself, not analyzing specimens taken from the body.
Therefore, the device falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Wireless digital flat panel detector is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is 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
Mars1013X Wireless Digital Flat Panel Detector (Hereinafter referred to as Mars1013X) is the 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: 33.18cm×25.28cm
The sensor plate of Mars1013X is direct-deposited with CsI(Cesium Iodide) 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 Mars1013X 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 intended 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 Found - implied medical professionals/DR system manufacturers in a general radiography setting
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, mechanical, environmental safety according to IEC/ES 60601-1 and IEC 60601-2-54 was performed, and EMC testing was also conducted in accordance with IEC 60601-1-2. All test results are meet the standard requirements.
The materials of the detector which contact operators' or patient's skin have been evaluated with the ISO 10993-1.
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 (Mars1417X, K210316).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Min. 0.60 at 1 lp/mm (Modulation Transfer Function)
Min. 0.43 at 1 lp/mm (RQA5, 2.5µGy) (Detective Quantum Efficiency)
Predicate Device(s)
Reference Device(s)
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
April 1, 2022
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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. % Junjie Oian Registration & Regulation Affairs Engineer No. 33 Xinggang Rd. Taicang Port Economic Technological Development Zone Taicang, Jiangsu 215434 CHINA
Re: K220668
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 11, 2021 Received: March 7, 2022
Dear Mr. Junjie 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
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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,
Laurel Burk, Ph.D. Assistant Director Diagnostic X-ray Systems Team 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
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Indications for Use
510(k) Number (if known) K220668
Device Name Wireless Digital Flat Panel Detector
Indications for Use (Describe)
Wireless digital flat panel detector is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is 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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510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
(As Required by 21 CFR 807.92)
1. Date Prepared [21 CFR 807.92(a)(1)]
November 11, 2021
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 21543- | |
| 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: | Mars1013X |
| Classification Name: | Stationary X-Ray System |
| Product Code: | MQB |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |
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4. Identification of Predicate Device(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: | Mars1417X |
| Product Code: | MQB |
| Classification Name: | Stationary X-Ray System |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |
| FDA 510 (k) #: | K210316 |
5. Identification of Reference Device(s) [21 CFR 807.92(a)(3)[
| Manufacturer: | iRay Technology Taicang Ltd. |
|---|---|
| Trade Name: | Wireless Digital Flat Panel Detector |
| Model Name: | Mars1717XF-CSI |
| Product Code: | MQB |
| Classification Name: | Stationary X-Ray System |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |
| FDA 510 (k) #: | K183713 |
6. Description of the Device [21 CFR 807.92(a)(4)]
Mars1013X Wireless Digital Flat Panel Detector (Hereinafter referred to as Mars1013X) is the 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: 33.18cm×25.28cm
The sensor plate of Mars1013X is direct-deposited with CsI(Cesium Iodide) scintillator to achieve the conversion from X-ray to visible photon. The visible photons are
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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 Mars1013X 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 intended 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.
7. Intended Use [21 CFR 807.92(a)(5)]
7.1. Indications for use
Mars1013X wireless digital flat panel detector is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is 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 X ray and output an imaging for diagnosis of disease, injury, or of any applicable health problem.
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| Item | Predicate Device:
Mars1417X
Wireless Digital Flat
Panel Detector | Proposed Device:
Mars1013X
Wireless Digital Flat
Panel Detector | Reference Device:
Mars1717XF-CSI
Wireless Digital
Flat Panel Detector |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | K210316 | K220668 | K183713 |
| Intended Use | Mars1417X Wireless
Digital Flat Panel
Detector is indicated
for digital imaging
solution designed for
providing general
radiographic system in
all general-purpose
diagnostic procedures. | Same | Same |
| Indications for
Use | Mars1417X wireless
digital flat panel
detector is indicated
for digital imaging
solutions designed to
provide general
radiographic diagnosis
for human anatomy
including both adult
and pediatric patients.
It is intended to
replace film/screen
systems in all general-
purpose diagnostic | Same | Same |
| | Predicate Device: | Proposed Device: | Reference Device: |
| Item | Mars1417X
Wireless Digital Flat
Panel Detector | Mars1013X
Wireless Digital Flat
Panel Detector | Mars1717XF-CSI
Wireless Digital
Flat Panel Detector |
| | procedures. The
device is not intended
for mammography or
dental applications. | | |
| | | | |
| | | | |
| Classification
Name | Stationary X-ray
system | Same | Same |
| Product Code | MQB | Same | Same |
| Regulation
Number | 21 CFR 892.1680 | Same | Same |
| Panel: | Radiology | Same | Same |
| Classification: | II | Same | Same |
| X-Ray Absorber
(Scintillator): | CsI | Same | Same |
| Installation Type: | Wireless, Portable | same | Same |
| Readout
Mechanism: | Thin Film Transistor | Same | Same |
| Image Matrix
Size: | 3500 × 4300 pixels | 3318 × 2528 pixels | 2832 × 2836 pixels |
| Pixel Size: | 100μm | 100μm | 150μm |
| ADC Digitization | 16 bit | Same | Same |
| Effective Imaging
Area: | 350.0 mm × 430.0 mm | 331.8 mm × 252.8 mm | 424.8 mm × 425.4 mm |
| Spatial
Resolution: | Min. 4.3lp/mm | Min. 4.3lp/mm | Min. 3.3lp/mm |
| Item | Predicate Device:
Mars1417X
Wireless Digital Flat
Panel Detector | Proposed Device:
Mars1013X
Wireless Digital Flat
Panel Detector | Reference Device:
Mars1717XF-CSI
Wireless Digital Flat Panel Detector |
| Modulation
Transfer
Function
(MTF) | 0.65 at 1 lp/mm | Min. 0.60 at 1 lp/mm | 0.49 at 1 lp/mm |
| Detective
Quantum
Efficiency
(DQE) | 0.54 at 1 lp/mm
(RQA5, 2.5µGy) | Min. 0.43 at 1 lp/mm
(RQA5, 2.5µGy) | 0.40 at 1 lp/mm
(RQA5, 2.5µGy) |
| Power
Consumption: | Max. 19W | Max. 18W | Max. 20W |
| Communications:
(Wireless
functionality) | a) Wired (only for
service) : Gigabit
Ethernet
(1000BASE-T)
b) Wireless: IEEE
802.11a/b/g/n/ac
(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) | Wireless: IEEE
802.11a/b/g/n
(2.4 GHz / 5 GHz) |
| Imaging protect
Plate: | Carbon Fiber Plate | Same | Same |
| Cooling: | Air cooling | Same | Same |
| Dimensions: | 384 mm × 460 mm ×
15 mm | 362.1 mm × 269.2 mm
× 15.5 mm | 460 mm × 460mm
× 15 mm |
| | Predicate Device: | Proposed Device: | Reference Device: |
| Item | Mars1417X
Wireless Digital Flat | Mars1013X
Wireless Digital Flat | Mars1717XF-CSI
Wireless Digital
Flat Panel Detector |
| | Panel Detector | Panel Detector | |
| Detector IP grade | IP56 | IPX5 | IPX4 |
| | adapter port input : | adapter port input : | adapter port input : |
| | 24Vdc 1.46A | 24Vdc 0.75A | 24Vdc 1.25A |
| Power input | Battery port input: | Battery port input: | Battery port input: |
| | 11.55Vdc 1.6A | 11.55Vdc 1.6A | 7.6Vdc 3500mAh |
| Surface pressure | Uniform load: 300 kg
over the whole area of
the surface;
Local load: 150 kg
on an area 4 cm
diameter of center | Uniform load: 150 kg
over the whole area of
the surface;
Local load: 100 kg on
an area 4 cm diameter
of center | Uniform load:
150 kg over the
whole area of the
surface;
Local load: 100
kg on an area 4 cm
diameter of center |
| Operation: | Temperature: +10 ~
+35°C
Humidity: 5 ~ 90%
(Non-Condensing)
Atmospheric pressure:
70 ~ 106 kPa
Altitude: Max. 3000
meters | Temperature: +10 ~
+35°C
Humidity: 5 ~ 90%
(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 |
| Item | Predicate Device: | Proposed Device: | Reference Device: |
| | Mars1417X
Wireless Digital Flat
Panel Detector | Mars1013X
Wireless Digital Flat
Panel Detector | Mars1717XF-CSI
Wireless Digital
Flat Panel Detector |
| Storage and
Transportation:
(detector) | Temperature: -20 ~ +55°C
Humidity: 5 ~ 95%
(Non-Condensing)
Atmospheric pressure: 60 ~ 106 kPa
Altitude: Max. 3000 meters | Temperature: -20 ~ +55°C
Humidity: 5 ~ 95%
(Non-Condensing)
Atmospheric pressure: 60 ~ 106 kPa
Altitude: Max. 3000 meters | Temperature: -20 ~ +50°C
Humidity: 10 ~ 90%
(Non-Condensing)
Atmospheric pressure: 70 ~ 106 kPa
Altitude: Max. 3000 meters |
| Software | 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 | Same |
8. Technological Characteristic [21 CFR 807.92(a)(6)]
7
8
9
10
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9. System requirements to operate with other radiographic system components
9.1. Recommended Generator Specification:
Energy range: 40~150kVp
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 the distributor or iRay's service office.
9.2. Application Program Interface (API) for system integration manufacturer Peripheral hardware: Mars1013X connected via wireless communication.
| Operating System: | Windows 10, 32/64bit |
|---|---|
| CPU: | Intel Core i7 3.6G |
| Memory: | 8G DDR3 |
| Hard Disk: | 640 G |
| LAN Card: | Intel Pro EXP9301CT PRO |
| Gigabit Network Adapter with PCIe interface |
9.3. X-ray exposure mode
The AED trigger module is a unit can connect X-ray signal in the Mars1013X. 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.
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10. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)]
10.1. Electrical Safety and EMC testing:
Electrical, mechanical, environmental safety according to IEC/ES 60601-1 and IEC 60601-2-54 was performed, and EMC testing was also conducted in accordance with IEC 60601-1-2. All test results are meet the standard requirements.
10.2. 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: 10.3.
One main modification from the predicate device is Amorphous Silicon (a-Si) panel size design, related to Amorphous Silicon (A-Si) panel size. Another main modification is structure design with different IP grade and different surface pressure performance.
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 (Mars1417X, K210316).
10.4. 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.
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11. 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 Mars1013X is substantially equivalent to predicate device with regards to safety and effectiveness.