Who is the manufacturer of Mercu 1717V?

Iray Technology Taicang , Ltd. filed the 510(k) submission for Mercu 1717V (K222886).

What is the FDA product code for Mercu 1717V?

MQB. It is classified under 21 CFR 892.1680 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Mercu 1717V?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like Mercu 1717V?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Mercu 1717V

K222886 · Iray Technology Taicang , Ltd. · MQB · Oct 20, 2022 · Radiology

Device Facts

Record ID	K222886
Device Name	Mercu 1717V
Applicant	Iray Technology Taicang , Ltd.
Product Code	MQB · Radiology
Decision Date	Oct 20, 2022
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.1680
Device Class	Class 2
Attributes	Pediatric

Intended Use

Mercu1717V 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.

Device Story

Mercu1717V is a stationary digital flat panel detector for general-purpose radiographic imaging. It utilizes a direct-deposited CsI scintillator to convert X-rays into visible photons, which are then transformed into electron signals by a TFT diode capacitor array. The device connects via wired Gigabit Ethernet to a PC running iRayDR software. It supports both static and dynamic imaging. The system is operated by healthcare professionals in clinical settings. The iRayDR software handles DICOM 3.0 communication, image acquisition, enhancement, and archiving. Output images are reviewed by clinicians to support diagnosis of disease or injury. The device replaces traditional film/screen systems, offering digital workflow benefits including image processing, measurement tools, and electronic storage.

Clinical Evidence

Bench testing only. No clinical data provided. Performance evaluated via image quality metrics including MTF, DQE, and spatial resolution compared to predicate. Software validated per FDA guidance for software in medical devices.

Technological Characteristics

Materials: CsI scintillator, TFT panel, carbon fiber protective plate. Connectivity: Wired Gigabit Ethernet. Power: 18W. Dimensions: 460x460x15mm. Environmental: IPX1 rating. Software: iRayDR (Moderate level of concern). Standards: IEC/ES 60601-1 (electrical/mechanical/environmental), IEC 60601-1-2 (EMC).

Indications for Use

Indicated for digital radiographic diagnosis of human anatomy in adult and pediatric patients. Not for mammography or dental applications.

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

Venu1717X (K221714)

Reference Devices

CareView 3600RF (K202995)

Related Devices

K221714 — Flat Panel Detector · Iray Technology Taicang , Ltd. · Jun 29, 2022
K220510 — Yushan X-Ray Flat Panel Detector with DROC · Innocare Optoelectronics Corp. · Apr 14, 2022
K212051 — RFA-1717DIG, RFA-1717DIC · Astel, Inc. · Aug 25, 2021
K171420 — 1717SCC_127um and 1717SCC_140um · Rayence Co., Ltd. · Jun 9, 2017
K161730 — Wireless Digital Flat Panel Detector · Iray Technology (Shanghai) , Ltd. · Dec 8, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ October 20, 2022 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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 Qian Registration & Regulation Affairs Engineer No. 33 Xinggang Rd., Taicang Port Economic Technological Development Zone Taicang, Jiangsu 215434 CHINA Re: K222886 Trade/Device Name: Mercu1717V Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: September 13, 2022 Received: September 23, 2022 Dear 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 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 {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K222886 Device Name Mercu1717V Indications for Use (Describe) Mercul 717V 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) | #### 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) K222886 ### 1. Date Prepared [21 CFR 807.92(a)(1)] July 13, 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 Technological Development Zone, Jiangsu, China 215434 | | Contact Person: | Junjie. Qian | | Phone: | 0512-53690872 | | Fax: | 0512-53690872 | | Email: | junjie.qian@iraygroup.com | ### 3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] | Trade Name: | Digital Flat Panel Detector | |----------------------|-----------------------------| | Common Name: | Solid State X-Ray Imager | | Model Name: | Mercu1717V | | 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 Co., Ltd. | |----------------------|---------------------------| | Trade Name: | Flat Panel Detectors | | Model Name: | Venu1717X | | Product Code: | MQB | | Classification Name: | Stationary X-Ray System | | Regulation Number: | 21 CFR 892.1680 | | Device Class: | Class II | | FDA 510 (k) #: | K221714 | ### 5. Identification of Reference Devices(s) [21 CFR 807.92(a)(3)[ | Manufacturer: | CareRay Digital Medical Technology Co., Ltd. | |----------------------|----------------------------------------------| | Trade Name: | X-ray Flat Panel Detectors | | Model Name: | CareView 3600RF | | Product Code: | MQB | | Classification Name: | Stationary X-Ray System | | Regulation Number: | 21 CFR 892.1680 | | Device Class: | Class II | | FDA 510 (k) #: | K202995 | #### 6. Description of the Device [21 CFR 807.92(a)(4)] Mercu1717V Digital Flat Panel Detectors (Hereinafter referred to as Mercu1717V) supports dynamic imaging and static imaging. The sensor plate of Mercu1717V 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 cable. {5}------------------------------------------------ The major function of the Mercu1717V is to convert the X-ray to digital image, with the application of high-resolution X-ray imaging. Mercu1717V can get single image and it also can get dynamic image. 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. The iRay DR used for digital X-ray radiography image from the digital flat panel detectors. iRay DR is used to handle the DICOM protocol (DICOM 3.0). iRay DR has many functions such as image acquisition, image enhancement processing and editing image or information. ### 7. Intended Use [21 CFR 807.92(a)(5)] ### 7.1. Indications for use Mercu1717V 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 Mercu1717V Digital flat panel detector get signal from high-voltage generator, and then it gets ready to output radiographic imaging for diagnosis of disease, injury, or of any applicable health problem to iRayDR installed in PC. iRayDR get raw image and output clinical image after enhancement processing for raw image is finished. {6}------------------------------------------------ | Item | Predicate Device: Venu1717X Digital Flat Panel Detector | Reference Device: CareView 3600RF X-ray Flat Panel Detector | Proposed Device: Mercu1717V Digital Flat Panel Detector | |------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(K) Number | K221714 | K202995 | K222886 | | Intended Use | 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. | The CareView 3600RF 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 product is not intended for mammography applications. | Mercu1717V Digital Flat Panel Detector is indicated for digital imaging solution designed for providing general radiographic system in all general-purpose diagnostic procedures. | | Indications for 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 | / | Mercu1717V 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 | | | Predicate Device: | Reference Device: | Proposed Device: | | Item | Venu1717X Digital Flat Panel Detector all general-purpose diagnostic procedures. | CareView 3600RF X-ray Flat Panel Detector | Mercu1717V Digital Flat Panel Detector mammography or dental applications. | | Classification Name | Stationary X-ray system | Stationary X-ray system | Same | | Product Code | MQB | MQB | Same | | Regulation Number | 21 CFR 892.1680 | 21 CFR 892.1680 | Same | | Panel: | Radiology | Radiology | Same | | Classification: | II | II | Same | | X-Ray Absorber (Scintillator): | CSI | GOS | CSI | | Installation Type: | Wired | Same | Same | | Readout Mechanism: | Thin Film Transistor | Same | Same | | Image Matrix Size: | 3072 × 3072 pixels | 5632 × 2816 pixels | Min. 1024 × 1024 pixels (@binning 3×3) Max.3072 ×3072 pixels (@binning 1×1) | | Pixel Size: | 139μm | 154 μm | 139μm | | ADC Digitization | 16 bit | Same | Same | | Effective Imaging Area: | 427mm×427mm | 867.5mm × 433.1 mm | Min.285mm×285mm (@zoom on) Max.427mm × 427mm (@zoom off) | | Spatial Resolution: | Min. 3.4 lp/mm | Same | Same | | | Predicate Device: Venu1717X Digital Flat Panel Detector | Reference Device: CareView 3600RF X-ray Flat Panel Detector | Proposed Device: Mercu1717V Digital Flat Panel Detector | | Item | | | | | MTF | 0.66 at 1 lp/mm | 0.75 at 0.5lp/mm 0.5 at 1lp/mm | 0.78 at 0.5lp/mm 0.55 at 1lp/mm | | Detective Quantum Efficiency (DQE) | 0.28 at 1 lp/mm (RQA5, 2.5µGy) | 0.28 at 0.5 lp/mm 0.20 at 1 lp/mm (RQA5, 3.2µGy) | 0.4 at 0.5 lp/mm 0.35 at 1 lp/mm (RQA5, 2.5µGy) | | Power Consumption: | Max. 20W | ~50W | 18 W | | Communications: | Gigabit Ethernet | Same | Same | | Imaging protect Plate: | Carbon Fiber Plate | Same | Same | | Cooling: | Air cooling | Same | Same | | Protection against matter/water | IPX1 | / | IPX1 | | Dimensions: | 460 mm × 460 mm × 15 mm | 916.9 mm × 486.4 mm × 42.8 mm | 460 mm × 460 mm × 15mm | | Frame rate | / | 3.5fps@1×1 15fps@2×2 25fps@4×4 | 5fps@1×1 20fps@2×2 30fps@3×3 | | Operation: | Temperature: +5 ~ +35°C Humidity: 30 ~ 80% (Non-Condensing) Atmospheric pressure: 70 ~ 106 | Temperature: +10 ~ +40°C Humidity: 30 ~ 75% (Non-Condensing) Atmospheric pressure: 700 ~ 1060 hPa | Temperature: +10 ~ +35°C Humidity: 20 ~ 90% (Non-Condensing) Atmospheric pressure: 700 ~ 1060 mbar Altitude: Max. 3000 meters | | Item | Predicate Device: Venu1717X Digital Flat Panel Detector | Reference Device: CareView 3600RF X-ray Flat Panel Detector | Proposed Device: Mercu1717V Digital Flat Panel Detector | | Storage and Transportation: ( detector ) | Temperature: 10 ~ +55℃ Humidity: 10 ~ 90% (Non-Condensing) Atmospheric pressure: 70 ~ 106 kPa Altitude: Max. 3000 meters | Temperature: -20 ~ +55℃ Humidity: 10 ~ 90% (Non-Condensing) Atmospheric pressure: 700 ~ 1060 hPa Altitude: Max. 3000 meters | Temperature: -10 ~ +55℃ Humidity: 10 ~ 95% (Non-Condensing) Atmospheric pressure: 700 ~ 1060 mbar Altitude: Max. 3000 meters | | Software | iDetector | CareRay software provides a set of predefined APIs ( Application Programming Interfaces ) , an adapter layer between a CareView 3600RF detector and an upstream program on the client side, commonly known as DROC (Digital Radiography Operator Console ) DROC communicates with the CareRay | The Mercu1717V Digital Flat Panel Detector is supported by software, named iRayDR. The iRayDR used for getting digital X-ray radiography images from the digital flat panel detectors. iRay DR is used to handle the DICOM protocol (DICOM 3.0). iRay DR has many functions such as patient registration, image acquisition, image display, image processing and image archiving. | | | Predicate Device: | Reference Device: | Proposed Device: | | Item | Venu1717X Digital Flat Panel Detector | CareView 3600RF X-ray Flat Panel Detector | Mercu1717V Digital Flat Panel Detector | | | | detectors via APIs. In general, APIs are provided in the form of DLL (Dynamic-Link Libraries) files. The upstream program imports these DLL files and calls relevant API commands to manipulate a CareView 3600RF detector-query status, select application mode, calibrate detector, acquire images, and preprocess images-without caring about the implementation details of the algorithm or workflow under the hood. | Image processing refers to some post-processing tools for the acquired image, including three parts of the common tools, the image post-processing tools and the measurement tools. Common tools: zoom, rotate, etc. Post-processing tools: adjust image contrast, brightness, etc. Measurement tools: line measurement, angle measurement. iRayDR software is of Moderate level of concern. | ### 8. Technological Characteristic [21 CFR 807.92(a)(6)] {7}------------------------------------------------ ## iRay Technology Taicang Ltd. # [510(k)] Application {8}------------------------------------------------ ### iRay Technology Taicang Ltd. # [510(k)] Application {9}------------------------------------------------ {10}------------------------------------------------ ### iRay Technology Taicang Ltd. ### [510(k)] Application ### 9. System requirements to operate with other radiographic system components - 1) Recommended Generator Specification: Energy range: 40~150kVp mA range: 10~1000mA (depending on the generator power) ms range: 10~6300ms to produce 0.1~1000mAs (depending on the generator power) {11}------------------------------------------------ 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. - 2) Peripheral hardware: Mercu1717V connected via wired communication. | Operating System: | Windows 10, 64bit | |-------------------|------------------------------------------------------------------------| | CPU: | Intel Core i5 8400 2.8G | | Memory: | 16G DDR4 | | Hard Disk: | 1T SSD | | LAN Card: | Intel Pro EXP9301CT PRO Gigabit Network Adapter with PCIe interface | - 3) X-ray exposure mode The digital flat panel detector gets ready to output image after it receive signal form high-voltage generator. The digital flat panel detector stops outputting image when there is no signal from high-voltage generator ### 10. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)] - Electrical Safety and EMC testing: 1) 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. - 2) Biological Evaluation: The digital flat panel detector is not intended to be touched by patient, so evaluation of bio-compatibility is not necessary. - 3) Non-clinical Considerations: {12}------------------------------------------------ The non-clinical studies have been performed and the results have shown that the Mercu1717V digital flat panel detector is substantially equivalent to the predicate devices on the Market (K221714) Parameter about image quality is equal to or better than predicate device parameter According to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, the software iRayDR 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: Intended use, fundamental scientific technology, regulatory requirement, non-clinical performance, labeling, quality-assurance program 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', ### 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 Mercu1717V is substantially equivalent to predicate device with regards to safety and effectiveness.