Flat Panel Detector

K221714 · Iray Technology Taicang , Ltd. · MQB · Jun 29, 2022 · Radiology

Device Facts

• Record ID: K221714
• Device Name: Flat Panel Detector
• Applicant: Iray Technology Taicang , Ltd.
• Product Code: MQB · Radiology
• Decision Date: Jun 29, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

Venu1717X is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including adults only. It is intended to replace film/screen systems in all general-purpose diagnostic procedures. This equipment provides digital X-ray imaging for diagnosis of disease, injury, or any applicable health problem. The image is obtained as the result of X-ray passing through the human body and detected by the equipment. iRay will provide equipment and software support for integration of system.

Device Story

Venu1717X is a cassette-size tethered X-ray flat panel detector using amorphous silicon TFT technology and a CsI scintillator. It captures X-ray radiation passing through the human body, converting it into digital radiographic images. The device supports multiple trigger modes for integration into general or retrofit DR systems. Operated by technicians or physicians in clinical settings, the detector connects via Gigabit Ethernet to a workstation running iRay SDK/iDetector software. The system provides high-quality images for the diagnosis of disease or injury. The device benefits patients by reducing exposure dose compared to traditional film/screen systems while providing digital diagnostic capabilities.

Clinical Evidence

Clinical evidence consisted of a concurrence study of 30 clinical images comparing the Venu1717X to the predicate device (Mars1717V-VSI). Results showed no significant difference between the images produced by the subject and predicate devices. Extensive bench testing was also performed, including dose-to-output signal transfer, SNR, uniformity, MTF, spatial resolution, and low-contrast resolution, all confirming substantial equivalence.

Technological Characteristics

Amorphous silicon TFT flat panel detector with CsI scintillator. Active matrix 3070x3070, 139um pixel pitch. Wired connectivity (Gigabit Ethernet). IPX1 ingress protection. Operating temperature +5 to +35°C. Software includes iDetector SDK for system integration. Complies with IEC/ES 60601-1, IEC 60601-2-54, and IEC 60601-1-2.

Indications for Use

Indicated for digital radiographic diagnosis of human anatomy in adult patients. Intended to replace film/screen systems in general-purpose diagnostic procedures. Not intended for mammography or dental applications; not recommended for pregnant women or newborns.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Wireless Digital Flat Panel Detector (Mars1717V-VSI) (K201043)

Submission Summary (Full Text)

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June 29, 2022

iRay Technology Taicang Ltd. % Guo Wu Registration & Regulation Affairs Engineer No. 33 Xinggang Rd. Taicang Port Economic & Technological Development Zone Taicang, Jiangsu 215434 CHINA

Re: K221714

Trade/Device Name: Flat Panel Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: MQB Dated: May 10, 2022 Received: June 13, 2022

Dear Guo Wu:

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K221714

Device Name Flat Panel Detector

Indications for Use (Describe)

Venul 717X 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 general-purpose diagnostic procedures.

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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# K221714 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

(As Required by 21 CFR 807.92)

#### 1. Date Prepared [21 CFR 807.92(a)(1)]

April 15, 2022

#### 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<br>Technological Development Zone, Jiangsu, China 215434 |
| Contact Person: | Guo Wu |
| Phone: | 0512- 50720539 |
| Fax: | 0512- 50720539 |
| Email: | [e-mail] |

#### 3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

| Trade Name: | Flat Panel Detector |
|----------------------|--------------------------|
| Common Name: | Solid State X-Ray Imager |
| Model Name: | Venu1717X |
| Classification Name: | Stationary x-ray system |
| Product Code: | MQB |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |

### 4. Identification of Predicate Devices(s)[21 CFR 807.92(a)(3)]

The identification predicates within this submission are as follows:

| Manufacturer: | iRay Technology Taicang Ltd. |
|---------------|--------------------------------------|
| Trade Name: | Wireless Digital Flat Panel Detector |
| Model Name: | Mars1717V-VSI |
| Product Code: | MQB |

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Classification Name: Stationary x-ray system FDA 510 (k) #: K201043

#### 5. Description of the Device [21 CFR 807.92(a)(4)]

Venu1717X is a cassette-size tethered X-ray flat panel detector based on amorphous silicon thin-film transistor technology. It is designed to provide the high quality radiographic image which contains an active matrix of 3070×3070 with 139um pixel pitch. The scintillator of Venu1717X is CsI(Caesium Iodide). The technology of CsI direct growth reduces the exposure dose and improves the image quality. Since Venu1717X supports multiple trigger modes, it can satisfy both of the general DR system and retrofit DR system.

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.

## 6. Intended Use [21 CFR 807.92(a)(5)]

#### 6.1. Intended Use

Venu1717X is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including adults only. It is intended to replace film/screen systems in all general-purpose diagnostic procedures. This equipment provides digital X-ray imaging for diagnosis of disease, injury, or any applicable health problem. The image is obtained as the result of X-ray passing through the human body and detected by the equipment.

iRay will provide equipment and software support for integration of system.

#### 6.2. Suitable patient

This panel is not intended for mammography or dental applications, and not recommend for pregnant women and new born.

#### 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

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health problem.

## 7. Technological Characteristic [21 CFR 807.92(a)(6)]

| Item | Predicate Device:<br>Wireless Digital Flat Panel<br>Detector | Proposed Device:<br>Flat Panel Detector |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | K201043 | K221714 |
| Intended Use | The Mars1717V-VSI Wireless<br>Digital Flat Panel Detector is<br>indicated for digital imaging<br>solution designed for providing<br>general radiographic system in<br>allgeneral-purpose diagnostic<br>procedures. | This equipment provides digital X-<br>ray imaging for diagnosis of<br>disease, injury, or any applicable<br>health problem. The image is<br>obtained as the result of X-ray<br>passing through the human body<br>and detected by the equipment.<br>iRay will provide equipment and<br>software support for integration of<br>system. |
| Indications for<br>Use | Mars1717V-VSI is indicated for<br>digital imaging solutions<br>designed to provide general<br>radiographic diagnosis for human<br>anatomy including both adult and<br>pediatric patients. It is intended to<br>replace film/screen systems in all<br>general-purpose diagnostic<br>procedures. | Venu1717X is indicated for digital<br>imaging solutions<br>designed to provide general<br>radiographic diagnosis for human<br>anatomy including adults only. It is<br>intended to replace film/screen<br>systems in all general-purpose<br>diagnostic procedures. |
| Classification<br>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<br>(Scintillator): | CsI | Same |
| Installation Type: | Wireless, Portable | Wired, Portable |
| Detector structure: | Amorphous silicon TFT | Same |
| | Predicate Device: | |
| Item | Wireless Digital Flat Panel | Proposed Device: |
| | Detector | Flat Panel Detector |
| Dimensions: | 460 mm× 460 mm × 15 mm | Same |
| Image Matrix Size: | 3072 × 3072 pixels | Same |
| Pixel Pitch: | 139μm | Same |
| Effective<br>Imaging<br>Area: | 427mm×427mm | Same |
| ADC<br>Digitization | 16 bit | Same |
| Spatial Resolution | Min. 3.6lp/mm | Min. 3.4 lp/mm |
| Modulation<br>Transfer<br>Function (MTF) | 0.65 at 1 lp/mm | 0.66 at 1 lp/mm |
| Detective<br>Quantum<br>Efficiency<br>(DQE) | 0.40 at 1 lp/mm (RQA5, 2.5µGy) | 0.28 at 1 lp/mm (RQA5, 2.5µGy) |
| Imaging protect<br>Plate: | Carbon Fiber Plate | Same |
| Power Consumption: | Max. 30W | Max. 20W |
| Communications: | a) Wired (only for<br>service): Gigabit<br>Ethernet (1000BASE-T)<br>b) Wireless: IEEE<br>802.11a/b/g/n/ac (2.4 GHz<br>/ 5 GHz) | Wired: Gigabit<br>Ethernet (1000BASE-T) |
| Cooling: | Air cooling | Same |
| Protection against<br>matter/Water | IPX1 | IPX1 |
| Protection against<br>shock | Type B applied part | Same |
| Operation: | Temperature: +5 ~ +35°C<br>Humidity: 5 ~ 95%<br>(Non-Condensing)<br>Atmospheric pressure: 55 ~<br>106 kPa<br>Altitude: Max. 3000 meters | Temperature: +5 ~ +35°C<br>Humidity: 30 ~ 80%<br>(Non-Condensing)<br>Atmospheric pressure: 70 ~ 106<br>kPa<br>Altitude: Max. 3000 meters |
| Storage and<br>Transportation:<br>( detector ) | Temperature: -10 ~ +55°C<br>Humidity: 5 ~ 95%<br>(Non-Condensing) | Temperature: 10 to 55°C<br>Humidity: 10 ~ 90%<br>(Non-Condensing) |
| Item | Predicate Device:<br>Wireless Digital Flat Panel<br>Detector | Proposed Device:<br>Flat Panel Detector |
| | Atmospheric pressure: 55 ~<br>106 kPa<br>Altitude: Max. 3000 meters | Atmospheric pressure: 70 ~ 106<br>kPa<br>Altitude: Max. 3000 meters |
| Software | iDetector | iDetector |

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## iRay Technology Taicang Ltd.

## [510(k)] Application

### 8. System requirements to operate with other radiographic system components

- 1) Recommended Generator Specification:
Energy range: 40~150kV

mA range: 10~1000mA (depending on the generator power)

ms range: 10~6300ms to produce 0.1~1000mAs (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.

- 2) Application Program Interface (API) for system integration manufacturer
Peripheral hardware: Venu1717X connected via wired communication.

| Operating System: | Windows 10 or above 32/64bit |
|-------------------|------------------------------------------------------------------|
| CPU: | Intel Core i7 dual core, or even higher |
| Memory: | 4G or higher |
| Hard Disk: | 160 G or higher |
| LAN Card: | Intel Gigabit CT adapter Network Interface Card<br>or equivalent |

- 3) X-ray exposure mode
The inner trigger module is a unit can connect X-ray signal in the Venu1717X. 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.

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#### 9. Nonclinical study

- 1) Electrical Safety and EMC testing:
Electrical, mechanical, environmental safety and performance testing according to IEC/ES 60601-1 and IEC60601-2-54 were performed, and EMC testing was also conducted in accordance with IEC 60601-1-2. All test results are meet the standard requirements.

- 2) Biological Evaluation:
The top cover surface film and painting materials of the detector may contact patients'skin, this has been evaluated with the ISO 10993-1. And the evaluation results and test result assured the safety the same as the predicate device.

- 3) Nonclinical Considerations:
According to the Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices, the non-clinical studies have been performed and the results have shown that the Venu1717X is substantially equivalent to the predicate devices on the Market (K201043):

Dose to output signal transfer function, Signal to noise ratio, uniformity, Defect, Minimum triggering dose rate, Modulation transfer function (MTF), Spatial resolution, Low contrast resolution and Image Acquisition time. According to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, the software SDK(contains iDetector) classifies the hazards, defines requirements specification and design specification, all the specification pass all the test cases and complies the intended design specification.

- 4) Clinical Consideration:
A concurrence study of 30 clinical images was conducted to compare the performance of the Venul 717X to that of the predicate device (Mars 1717V-VSI, K201043).

Clinical images were provided; these images were not necessary to establish substantial equivalence based on the differences from the predicate but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended.

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There was no significant difference between the images of the Venu1717X and those of the predicate device.

- 5) Cybersecurity:
According to the Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, the Venu1717X had passed the assessment related to Cybersecurity.

## 10. Conclusion

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 Venu1717X is substantially equivalent to predicate device with regards to safety and effectiveness.