Who is the manufacturer of Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))?

Shenzhen Sontu Medical Imaging Equipment Co., Ltd. filed the 510(k) submission for Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) (K242499).

What is the FDA product code for Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))?

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

What is the regulatory pathway for Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))?

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

What are the predicate devices for Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))?

MULTIX Impact E VB10 (K220919); MULTIX Impact (VA21) (K213700).

Who can help prepare an FDA 510(k) submission like Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))?

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.

Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))

K242499 · Shenzhen Sontu Medical Imaging Equipment Co., Ltd. · KPR · Jan 6, 2025 · Radiology

Device Facts

Record ID	K242499
Device Name	Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))
Applicant	Shenzhen Sontu Medical Imaging Equipment Co., Ltd.
Product Code	KPR · Radiology
Decision Date	Jan 6, 2025
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1680
Device Class	Class 2

Intended Use

The Digital radiography X-ray system is used in hospitals, clinics, and medical practices. The Digital radiography X-ray system enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on adult and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. It is not intended for mammographic applications. The Digital radiography X-ray system uses digital detectors for generating diagnostic images by converting X-rays into image signals.

Device Story

Digital Radiography X-ray System is a modular stationary X-ray system for hospitals and clinics. It utilizes an X-ray tube, high-frequency generator, and digital detectors (wireless or fixed) to capture radiographic images. The system supports patient positioning (sitting, standing, prone) for whole-body imaging. Operators (technicians/physicians) use the system to generate diagnostic images by converting X-rays into signals. Output is displayed for clinical review to assist in diagnostic decision-making. The device provides a range of configurations for different clinical needs, including manual or motorized components for tube and detector positioning.

Clinical Evidence

Bench testing only. Performance verified via non-clinical testing including electrical safety (IEC 60601-1, 1-2, 1-3, 1-6, 2-28, 2-54), EMC, and X-ray tube characteristics. Detector performance (MTF, DQE, spatial resolution) compared to predicates. Concurrence evaluation of clinical images (chest, spine, extremities, skull, pelvis) confirmed equivalent diagnostic capability.

Technological Characteristics

Stationary X-ray system; 50kW high-frequency generator; manual/motorized tube stands; fixed/wireless digital flat panel detectors. Materials/biocompatibility consistent with predicates. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-28, IEC 60601-2-54, IEC 60601-1-3, IEC 60613, IEC 60336, ASTM D4169, ANSI IEEE C63.27. Software level of concern: Basic.

Indications for Use

Indicated for radiographic exposures of the whole body (skull, chest, abdomen, extremities) in adult and bariatric patients. Not for mammography.

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

MULTIX Impact E VB10 (K220919)
MULTIX Impact (VA21) (K213700)

Related Devices

K141381 — DURADIAGNOST · Philips Healthcare (Suzhou) Co., Ltd. · Jun 12, 2014
K082604 — VIZTEK DR, MODELS: DR1000, DR3000, DR4000 · Viztek, Inc. · Nov 21, 2008
K190601 — MasteRad MX30 · Medicatech USA · Apr 25, 2019
K132921 — GALAXY PLUS · Medien International Co, Ltd. · Jan 17, 2014
K201640 — DuraDiagnost · Philips Healthcare (Suzhou) Co., Ltd. · Jul 9, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 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. January 6, 2025 Shenzhen SONTU Medical Imaging Equipment Co., Ltd. % Mike Gu RA Director Room 1001, Building 19, No. 3188 Renming Road Suzhou, Jiangsu 215031 CHINA Re: K242499 Trade/Device Name: Digital Radiography X-ray System (SONTU100-RAD (E), SONTU300-Mars (E)) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: KPR, MQB Dated: August 15, 2024 Received: December 6, 2024 Dear Mike Gu: 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 (the 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 available 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. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory {2}------------------------------------------------ assistance/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, Lu Jiang Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K242499 Device Name Digital Radiography X-Ray System (Sontu100-Rad(E), Sontu300-Mars(E)) #### Indications for Use (Describe) The Digital radiography X-ray system is used in hospitals, clinics, and medical practices. The Digital radiography X-ray system enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on adult and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. It is not intended for mammographic applications. The Digital radiography X-ray system uses digital detectors for generating diagnostic images by converting X-rays into image signals. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X 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." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a company name in Chinese characters. The company name is "深圳市深图医学影像设备有限公司". The characters are black and bolded, and they are arranged horizontally. The background is white. Image /page/4/Picture/1 description: The image shows the logo for SONTU Medical Imaging. The logo consists of a stack of overlapping circles in shades of blue and orange on the left, with the word "SONTU" in bold, black letters to the right. Below "SONTU" is the phrase "Medical Imaging" in a smaller, lighter font. Shenzhen SONTU Medical Imaging Equipment Co., LTD ## 510(k) Summary ## Submission: K242499 In accordance with 21 CFR 807.92 the following summary of information is provided: - 1. Sponsor Identification Shenzhen SONTU Medical Imaging Equipment Co.,LTD 101, 202, Building 1, Shenzhen Biomedicine Innovations Industrial Park, No. 14 Jinhui Road, Jinsha Community, Kengzi Street, Pingshan District, Shenzhen, Guangdong Province 518122, PEOPLE'S REPUBLIC OF CHINA. Contact Person: Lao Xiaomei RA manager Shenzhen SONTU Medical Imaging Equipment Co.,LTD. Tel: (+86) -15915809355 Email: laoxiaomei@sontu.com Date prepared July 30, 2024 - 2. Designated Submission Correspondent Mr. Mike Gu (Primary Contact Person) Suzhou Device Innovation Medical Consulting Co., Ltd Room 1001, Building 19, No. 3188 Renming Road, Suzhou, Jiangsu, 215031, China Tel: +86-13914019083, Email: gxzn008@126.com - 3. DEVICE Device Name: Digital Radiography X-ray System (Sontu100-Rad(E), Sontu300-Mars(E)) Common name: Stationary x-ray system Regulation number 21 CFR 892.1680 Regulation Class: Class II Product Code: KPR, MQB - 4. PREDICATE DEVICE {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for SONTU Medical Imaging. The logo features a stack of five rounded shapes in different colors on the left side. The colors of the shapes are light blue, dark blue, orange, and yellow. To the right of the shapes is the word "SONTU" in a bold, sans-serif font. Below "SONTU" is the phrase "Medical Imaging" in a smaller, lighter font. 深圳市深图医学影像设备有限公司 Shenzhen SONTU Medical Imaging Equipment Co., LTD | Device Name: | Digital Radiography X-ray System (K220919, MULTIX Impact E VB10 K213700, MULTIX Impact (VA21)) | |-------------------|---------------------------------------------------------------------------------------------------| | Common name: | Stationary x-ray system | | Regulation number | 21 CFR 892.1680 | | Regulation Class: | Class II | | Product Code: | KPR, MQB | #### 5. DEVICE DESCRIPTION The Digital Radiography X-ray System is a radiography X-ray system. It is designed as a modular system with components such as a ceiling suspension with an X-ray tube, Bucky wall stand, Bucky table, X-ray generator, portable wireless, and fixed integrated detectors that may be combined into different configurations to meet specific customer needs. Software is of Basic level of concern, which is also based on a predicate device. Table 1 Product models | System | Model | |----------------------------------|---------------------------------------------------------------------------------------------| | Digital Radiography X-ray System | SONTU100-RAD(E) including SONTU100-RAD(E)-A, SONTU100-RAD(E)-B, SONTU100-RAD(E)-C | | Digital Radiography X-ray System | SONTU300-Mars(E) including SONTU300-Mars (E)-A, SONTU300-Mars (E)-B, SONTU300-Mars (E)-C | | Model | Wireless/ wire | Automated Exposure Control function (AEC) | New or based on a predicate device | |-----------------|-------------------|-------------------------------------------------|---------------------------------------| | SONTU50-4343S-C | Wire | Yes | Based on a predicate device | | SONTU50-4343W-C | Wireless | Yes | Based on a predicate device | | SONTU50-4336W-C | Wireless | Yes | Based on a predicate device | | SONTU50-4336S-C | Wire | yes | Based on a predicate device | #### 6. INDICATIONS FOR USE The Digital radiography X-ray system is used in hospitals, clinics, and medical practices. The Digital radiography X-ray system enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on adult and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. It is not intended for mammographic applications. The Digital radiography X-ray system uses digital detectors for generating diagnostic images by converting X-rays into image signals. #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE 7. The subject device is the same as the predicate device in the intended use, material, {6}------------------------------------------------ Image /page/6/Picture/0 description: The image is a logo for SONTU Medical Imaging. The logo consists of a stack of colored discs on the left and the word "SONTU" in bold, black letters on the right. Below the word "SONTU" is the phrase "Medical Imaging" in a smaller, lighter font. The discs are stacked in a gradient of colors, from light blue at the top to yellow at the bottom. Shenzhen SONTU Medical Imaging Equipment Co., LTD biocompatibility, and similar in product style, design feature and dimension. So the subject device is similar to the predicate device. | Table 2: Comparison of the Digital Radiography X-ray System SONTU100-RAD(E) to the predicate | | |----------------------------------------------------------------------------------------------|--| | device. | | | ITEM | Proposed Device | Predicate Device K220919 | Remark | |-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | Digital Radiography X-ray System | Stationary x-ray system | / | | Model | SONTU100-RAD(E) | MULTIX Impact E | / | | Product Code | KPR, MQB | KPR, MQB | Same | | Regulation Number | 21 CFR 892.1680 | 21 CFR 892.1680 | Same | | Class | II | II | Same | | Indications for Use | The Digital radiography X-ray system is used in hospitals, clinics, and medical practices. The Digital radiography X-ray system enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on adult and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. It is not intended for mammographic applications. The Digital radiography X-ray system uses digital detectors for generating diagnostic images by converting X-rays into image signals. | MULTIX Impact E is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact E enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and obese patients. Exposures may be taken with the patient sitting, standing, or in the prone position. MULTIX Impact E uses digital detectors for generating diagnostic images by converting X- rays into image signals. MULTIX Impact E is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes. MULTIX Impact E is not intended for mammography. | Same SONTU100-RAD(E) covers the same target population for adult and bariatric patients as compared to the predicate device but excludes the pediatric. Safety and effectiveness of the system remains same as compared to the predicated device for stationary x-ray system. | | Generator | 50KW high frequency X-ray Generator with line voltage 3- phase, 380V (50/60Hz) and with line voltage 1- phase, 220V/110V (50/60Hz) NA | 50KW high frequency X-ray Generator with line voltage 3- phase, 380V / 400V / 440V (50/60Hz), 480 V (60Hz) 40KW high frequency X-ray Generator with line voltage 1- phase, 208-230V /(50/60Hz) | Same. The line voltage 3- phase of Predicate Device covers the range of Proposed Device, this difference doesn't raise the issue of the product's safety and effectiveness. | | | Voltage:40kV~150kV Current:10mA~630mA Current time product:0.1mAs~1000mAs Exposure time:1ms~10000ms | /(50/60Hz) Voltage:40kV~150kV Current:Max 50A Current time product:50 kW: 0.5 mAs to 800 mAs | For the line voltage 1- phase, voltage, current, Current time product, and exposure time, the proposed device has been tested and verified about the electrical safety according to IEC 60601- | | | | | 1:2005+A1:2012+A2:2020, IEC 60601-1- 3:2008+A1:2013+A2:2021, IEC 60601-2-28:2017 and IEC 60601-2-54:2022. EMC test also has been conducted according to IEC 60601-1-2:2020. This difference does not affect the safety and effectiveness of the product. | | X-ray Tube | LQ 16 tube with following key performance: -Heat capacity of anode: 212KJ (300kHU) -Input Power with Ref.355W:54KW -Anode rotary frequency: 50/60 Hz (2800/3200 rpm) E7843X tube with following key performance: -Heat capacity of anode: 111KJ (150kHU) -Input Power with Ref.142W:50KW -Anode rotary frequency: 50/60 Hz (2700/3200 rpm) E7252X tube with following key performance: -Heat capacity of anode: 210KJ (300kHU) -Input Power with Ref.142W:44.6KW -Anode rotary frequency: 50/60 Hz (2700/3200 rpm) | RAY-12_3S tube with following key performance: -Heat capacity of anode: 170KJ (230kHU) -Input Power with Ref.300W: 54KW -Anode rotary frequency: 50/60 Hz (3000/3600 rpm) | Similar. LQ 16 and E7252X have more heat capacity of anode heat capacity means it can continuous exposure of more images or exposure under higher conditions. So-the proposed device is more clinically-beneficial than Predicate Device. Performance for E7843X reduced for lower cost and low-end market. Proposed Device provides more options for market needs. This difference does not affect the safety and effectiveness of the product | | Collimator | Manual collimator with feedback following information to system: -Blade positions | Manual collimator with feedback following information to system: -Blade positions -Cu filter status | Similar. Proposed Device's collimator reduced Configuration for lower cost and low-end market. The collimator with system has been tested and verified about the electrical safety according to IEC 60601- 1:2005+A1:2012+A2:2020, IEC 60601-1- 3:2008+A1:2013+A2:2021, and IEC 60601-2-54:2022. Verification and Validation testing concluded no impact on safety and effectiveness. | | Detector | SONTU50-4343S-C SONTU50-4343W-C SONTU50-4336W-C | Wireless detector: Mars1717VS | Similar, Proposed Device's detector was tested compared with | | | | | | | | SONTU50-4336S-C | | Predicate Device's detector, verification and validation testing concluded Proposed Device's detector is equivalent to Predicate Device's detector 's detector. All the flat panel detectors have been tested with system. The system has been tested and a risk analysis performed. There is “No negative impact on safety or efficacy” and no new potential or increased safety risks concerning were raised because of this difference. | | Floor mounted tube stand | Table mounted tube stand Integrated fully manual TS - Manual tube tilting - Manual longitudinal movement - Manual tube lifting | Integrated fully manual TS - Manual tube tilting - Manual longitudinal movement - Manual tube lifting | Same | | Automatic Exposure Control (AEC) | 3 fields AEC chamber with analog interface to system | 3 fields AEC chamber with analog interface to system | Same | | Patient Table | Fixed table with integrated rail mounting tube stand | Fixed table with integrated rail mounting tube stand | Same | | Human Machine Interface (HMI) | Tube-side control module (TCM) with following functions: -SID display -Tube angle display -Release brakes | Tube-side control module (TCM) with following functions: -SID display -Tube angle display -Release brakes Touch User Interface module (TUI) | Same Configuration reduced for lower cost and low-end market. This difference does not affect the safety and effectiveness of the product. | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for SONTU Medical Imaging. The logo consists of a stack of six horizontally oriented ovals on the left side, with the top three ovals in shades of blue and the bottom three ovals in shades of orange. To the right of the ovals is the word "SONTU" in a bold, sans-serif font. Below the word "SONTU" is the phrase "Medical Imaging" in a smaller, lighter font. ## 深圳市深图医学影像设备有限公司 Shenzhen SONTU Medical Imaging Equipment Co., LTD {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for SONTU Medical Imaging. The logo consists of a stack of six rounded shapes in different shades of blue and orange on the left, with the word "SONTU" in bold, black letters to the right. Below "SONTU" is the phrase "Medical Imaging" in a smaller, lighter font. Shenzhen SONTU Medical Imaging Equipment Co., LTD ## Table 3 Comparison of the Digital Radiography X-ray System SONTU300-Mars(E) to the predicate device. | ITEM | Proposed Device | Predicate Device K213700 | Remark | |----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | Digital Radiography X-ray System | Stationary x-ray system | / | | Model | SONTU300-Mars(E) | MULTIX Impact; | / | | Product Code | KPR, MQB | KPR, MQB | Same | | Regulation Number | 21 CFR 892.1680 | 21 CFR 892.1680 | Same | | Class | II | II | Same | | Indications for Use | The Digital radiography X-ray system is used in hospitals, clinics, and medical practices. The Digital radiography X-ray | MULTIX Impact is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact | Similar SONTU300-Mars(E) covers the same target population for adult and | | | system enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on adult and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. It is not intended for mammographic applications. The Digital radiography X-ray system uses digital detectors for generating diagnostic images by converting X-rays into image signals. | enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. MULTIX Impact is not intended for mammography. MULTIX Impact uses digital detectors for generating diagnostic images by converting X- rays into image signals. MULTIX Impact is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes. | bariatric patients as compared to the predicate device but excludes the pediatric. Safety and effectiveness of the system remains same as compared to the predicated device for stationary x-ray system. | | Generator | 50KW high frequency X-ray Generator with line voltage 3- phase, 380V (50/60Hz), 50KW high frequency X-ray Generator with line voltage 1- phase, 220V/110V (50/60Hz) Voltage:40kV~150kV Current:10mA~630mA Current time product:0.1mAs~1000m mAs Exposure time:1ms~10000ms | Polydoros RFX 56 kW high frequency X-ray Generator with line voltage 3- phase,380 V/400 V/440 V (50/60 Hz); 480 V (60 Hz) Voltage:40kV~150kV Current:Max 50A Current time product:0.5 mAs to 800 mAs for 55 kW/65 kW 0.5 mAs to 1000 mAs for 80 kW | Similar Output Power of Proposed Device is similar to the predicate device. The line voltage 3- phase of Predicate Device covers the range of Proposed Device, this difference doesn't raise the issue of the product's safety and effectiveness. For the line voltage 1- phase, voltage, current, Current time product, and exposure time, the proposed device has been tested and verified about the electrical safety according to IEC 60601- 1:2005+A1:2012+A2:2020, IEC 60601-1- 3:2008+A1:2013+A2:2021, IEC 60601-2-28:2017 and IEC 60601-2-54:2022. EMC test also has been conducted according to IEC 60601-1-2:2020. This difference does not affect the safety and effectiveness of the | | | | | product. | | X-ray Tube | LQ 16 tube with following key performance: -Heat capacity of anode: 212KJ (300kHU) -Input Power with Ref.355W:54KW -Anode rotary frequency: 50/60 Hz (2800/3200 rpm) E7843X tube with following key performance: -Heat capacity of anode: 111KJ (150kHU) -Input Power with Ref.142W:50KW -Anode rotary frequency: 50/60 Hz (2700/3200 rpm) E7252X tube with following key performance: -Heat capacity of anode: 210KJ (300kHU) -Input Power with Ref.142W:44.6KW -Anode rotary frequency: 50/60 Hz (2700/3200 rpm) | RAY-14S_3F RAY-14S_3F tube with following key performance: -Heat capacity of anode: 260KJ (350kHU) -Input Power with Ref.300W: 78KW -Anode rotary frequency: 150/180 Hz(≈ 8500 to 10800 rpm) | Similar. LQ16, E7843X and E7252X are for lower cost andlow-end market. Proposed Device provides more options for market needs. | | Collimator | Manual collimator | Manual collimator - Collimator ML03 - Collimator ML04 - Collimator RFU Motorized collimator - Collimator ML04 - Collimator RFU | Same | | Detector | SONTU50-4343S-C SONTU50-4343W-C/ SONTU50-4336W-C/ SONTU50-4336S-C | Trixell Pixium 3543EZH (MAX wi-D) iRay Mars1717VS (Core XL) iRay Venu1717X (Core Static) | Similar. Proposed Device's detector was tested compared with Predicate Device's detector, verification and validation testing concluded Proposed Device's detector is equivalent to Predicate Device's detector 's detector. All the flat panel detectors have been tested with system. The system has been tested and a risk analysis performed. There is “No negative impact on safety or efficacy” and no new pot…