(137 days)
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.
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.
The provided documents describe the Digital Radiography X-ray System (Sontu100-Rad(E), Sontu300-Mars(E)) and its substantial equivalence to predicate devices (K220919 and K213700). However, the document does not contain specific acceptance criteria, reported device performance metrics in numerical form, details about a clinical study for comparative effectiveness, or information regarding ground truth establishment beyond comparison to predicate device characteristics and phantom/patient images.
Based on the information provided, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document mentions that "all the performance parameters of flat panel detector meet the requirements, and the performance parameters of proposed detector and predicate detector are the same." It also states that a "concurrence evaluation on a certain number of clinical images from the same phantom or patients" was performed, and the results "show the ability of the device to provide images with equivalent diagnostic capability to those of the cleared predicate devices."
However, specific quantitative acceptance criteria and their corresponding reported performance values are not provided in the document. The document primarily focuses on demonstrating substantial equivalence through component and technical characteristic comparisons with predicate devices and compliance with relevant IEC and ASTM standards.
2. Sample size used for the test set and the data provenance
The document mentions "a certain number of clinical images from the same phantom or patients" for the concurrence evaluation.
- Sample size: "a certain number" (specific number not provided).
- Data provenance: "clinical images from the same phantom or patients". The country of origin is not specified, nor is whether the data is retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document.
4. Adjudication method for the test set
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC study: The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study.
- AI assistance: The device described is a Digital Radiography X-ray System, which is hardware for generating images. There is no mention of AI assistance or an AI component in this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Since there is no mention of an AI algorithm or software component for image analysis (beyond the basic level of concern software managing the X-ray system), a standalone algorithm-only performance study like this is not applicable and not mentioned. The "performance data" refers to the overall X-ray system and its detector's image quality.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document indicates that the performance of the flat panel detectors was evaluated based on standard image quality metrics (Effect Image Area, Linear Dose Range, Linear Dynamic Range, Spatial Resolution, Low Contrast Resolution, Flat Uniformity, Modulation Transfer Function, Detective Quantum Efficiency, Artifact, Erasure Thoroughness) and comparison to predicate devices. For clinical images, a "concurrence evaluation" was performed to show "equivalent diagnostic capability to those of the cleared predicate devices." This suggests the ground truth was implied to be equivalent to the diagnostic output of the predicate devices, likely through comparison of images by human readers, but the specifics of how this diagnostic capability was established as ground truth (e.g., expert consensus) are not detailed.
8. The sample size for the training set
The document describes an X-ray imaging system, not a device that uses a training set for machine learning. Therefore, a "training set" in this context is not applicable and not mentioned.
9. How the ground truth for the training set was established
As there is no training set for this type of device, this information is not applicable.
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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.
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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
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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
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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)
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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:
-
- 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.
- Sponsor Identification
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
-
- 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
- Designated Submission Correspondent
-
- 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
- DEVICE
-
- PREDICATE DEVICE
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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 VB10K213700, 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 | AutomatedExposure Controlfunction (AEC) | New or based on a predicatedevice |
|---|---|---|---|
| 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,
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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 DeviceK220919 | 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 |
| RegulationNumber | 21 CFR 892.1680 | 21 CFR 892.1680 | Same |
| Class | II | II | Same |
| Indications forUse | The Digital radiography X-raysystem is used in hospitals,clinics, and medical practices.The Digital radiography X-raysystem enables radiographicexposures of the whole bodyincluding: skull, chest,abdomen, and extremities andmay be used on adult andbariatric patients. Exposuresmay be taken with the patientsitting, standing, or in theprone position. It is notintended for mammographicapplications.The Digital radiography X-raysystem uses digital detectorsfor generating diagnosticimages by converting X-raysinto image signals. | MULTIX Impact E is aradiographic system used inhospitals, clinics, and medicalpractices. MULTIX Impact Eenables radiographicexposures of the whole bodyincluding: skull, chest,abdomen, and extremities andmay be used on pediatric,adult and obese patients.Exposures may be taken withthe patient sitting, standing, orin the prone position.MULTIX Impact E uses digitaldetectors for generatingdiagnostic images byconverting X- rays into imagesignals. MULTIX Impact E isalso designed to be used withconventional film/screen orComputed Radiography (CR)cassettes.MULTIX Impact E is notintended for mammography. | SameSONTU100-RAD(E) coversthe same target populationfor adult and bariatricpatients as compared tothe predicate device butexcludes the pediatric.Safety and effectiveness ofthe system remains sameas compared to thepredicated device forstationary x-ray system. |
| Generator | 50KW high frequency X-rayGenerator with line voltage 3-phase, 380V (50/60Hz) and withline voltage 1- phase, 220V/110V(50/60Hz)NA | 50KW high frequency X-rayGenerator with line voltage 3-phase, 380V / 400V / 440V(50/60Hz), 480 V (60Hz)40KW high frequency X-rayGenerator with line voltage 1-phase, 208-230V/(50/60Hz) | Same.The line voltage 3- phase ofPredicate Device covers therange of Proposed Device, thisdifference doesn't raise theissue of the product's safetyand effectiveness. |
| Voltage:40kV | /(50/60Hz)Voltage:40kV~150kVCurrent:Max 50ACurrent time product:50 kW: 0.5mAs to 800 mAs | For the line voltage 1- phase,voltage, current, Current timeproduct, and exposure time,the proposed device has beentested and verified about theelectrical safety according toIEC 60601- | |
| 1:2005+A1:2012+A2:2020, IEC60601-1-3:2008+A1:2013+A2:2021, IEC60601-2-28:2017 and IEC60601-2-54:2022.EMC test also has beenconducted according to IEC60601-1-2:2020.This difference does not affectthe safety and effectiveness ofthe product. | |||
| X-ray Tube | LQ 16 tube with following keyperformance:-Heat capacity of anode: 212KJ(300kHU)-Input Power withRef.355W:54KW-Anode rotary frequency: 50/60Hz (2800/3200 rpm)E7843X tube with following keyperformance:-Heat capacity of anode: 111KJ(150kHU)-Input Power withRef.142W:50KW-Anode rotary frequency: 50/60Hz (2700/3200 rpm)E7252X tube with following keyperformance:-Heat capacity of anode: 210KJ(300kHU)-Input Power withRef.142W:44.6KW-Anode rotary frequency: 50/60Hz (2700/3200 rpm) | RAY-12_3S tube with followingkey performance:-Heat capacity of anode: 170KJ(230kHU)-Input Power with Ref.300W:54KW-Anode rotary frequency: 50/60Hz (3000/3600 rpm) | Similar.LQ 16 and E7252X have moreheat capacity of anode heatcapacity means it cancontinuous exposure of moreimages or exposure underhigher conditions. So-theproposed device is moreclinically-beneficial thanPredicate Device.Performance for E7843Xreduced for lower cost andlow-end market. ProposedDevice provides more optionsfor market needs.This difference does not affectthe safety and effectiveness ofthe product |
| Collimator | Manual collimator with feedbackfollowing information to system:-Blade positions | Manual collimator with feedbackfollowing information to system:-Blade positions-Cu filter status | Similar.Proposed Device's collimatorreduced Configuration forlower cost and low-endmarket.The collimator with system hasbeen tested and verified about the electrical safety accordingto IEC 60601-1:2005+A1:2012+A2:2020, IEC60601-1-3:2008+A1:2013+A2:2021, andIEC 60601-2-54:2022.Verification and Validationtesting concluded no impacton safety and effectiveness. |
| Detector | SONTU50-4343S-CSONTU50-4343W-CSONTU50-4336W-C | Wireless detector: Mars1717VS | Similar,Proposed Device's detectorwas 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. | ||
| Floormountedtube stand | Table mounted tube standIntegrated fully manual TS- Manual tube tilting- Manual longitudinalmovement- Manual tube lifting | Integrated fully manual TS- Manual tube tilting- Manual longitudinalmovement- Manual tube lifting | Same |
| AutomaticExposureControl(AEC) | 3 fields AEC chamber with analoginterface to system | 3 fields AEC chamber with analoginterface to system | Same |
| Patient Table | Fixed table with integrated railmounting tube stand | Fixed table with integrated railmounting tube stand | Same |
| HumanMachineInterface(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 brakesTouch User Interface module(TUI) | SameConfiguration reduced for lower cost and low-endmarket.This difference does not affect the safety and effectiveness ofthe product. |
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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
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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 DeviceK213700 | 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 | SimilarSONTU300-Mars(E) covers the same target population for adult and |
| system enables radiographicexposures of the whole bodyincluding: skull, chest, abdomen,and extremities and may be used onadult and bariatric patients.Exposures may be taken with thepatient sitting, standing, or in theprone position. It is not intended formammographic applications.The Digital radiography X-raysystem uses digital detectors forgenerating diagnostic images byconverting X-rays into imagesignals. | enables radiographicexposures of the whole bodyincluding: skull, chest,abdomen, and extremitiesand may be used onpediatric, adult and bariatricpatients.Exposures may be taken withthe patient sitting, standing,or in the prone position.MULTIX Impact is notintended for mammography.MULTIX Impact uses digitaldetectors for generatingdiagnostic images byconverting X- rays into imagesignals. MULTIX Impact is alsodesigned to be used withconventional film/screen orComputed Radiography (CR)cassettes. | bariatric patients ascompared to thepredicate device butexcludes the pediatric.Safety and effectivenessof the system remainssame as compared to thepredicated device forstationary x-ray system. | |
| Generator | 50KW high frequency X-ray Generatorwith line voltage 3- phase, 380V(50/60Hz),50KW high frequency X-ray Generatorwith line voltage 1- phase, 220V/110V(50/60Hz)Voltage:40kV | Polydoros RFX56 kW high frequency X-rayGenerator with line voltage 3-phase,380 V/400 V/440 V (50/60Hz); 480 V (60 Hz)Voltage:40kV~150kVCurrent:Max 50ACurrent time product:0.5 mAsto 800 mAs for 55 kW/65 kW0.5 mAs to 1000 mAs for 80 kW | SimilarOutput Power of ProposedDevice is similar to thepredicate device.The line voltage 3- phaseof Predicate Device coversthe range of ProposedDevice, this differencedoesn't raise the issue ofthe product's safety andeffectiveness.For the line voltage 1-phase, voltage, current,Current time product, andexposure time, theproposed device has beentested and verified aboutthe electrical safetyaccording to IEC 60601-1:2005+A1:2012+A2:2020,IEC 60601-1-3:2008+A1:2013+A2:2021,IEC 60601-2-28:2017 andIEC 60601-2-54:2022.EMC test also has beenconducted according toIEC 60601-1-2:2020.This difference does notaffect the safety andeffectiveness of the |
| product. | |||
| X-ray Tube | LQ 16 tube with following keyperformance:-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 keyperformance:-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 keyperformance:-Heat capacity of anode: 210KJ(300kHU)-Input Power with Ref.142W:44.6KW-Anode rotary frequency: 50/60 Hz(2700/3200 rpm) | RAY-14S_3FRAY-14S_3F tube with followingkey performance:-Heat capacity of anode: 260KJ(350kHU)-Input Power with Ref.300W:78KW-Anode rotary frequency:150/180 Hz(≈ 8500 to 10800rpm) | Similar.LQ16, E7843X and E7252Xare for lower cost andlow-end market.Proposed Device providesmore options for marketneeds. |
| Collimator | Manual collimator | Manual collimator- Collimator ML03- Collimator ML04- Collimator RFUMotorized collimator- Collimator ML04- Collimator RFU | Same |
| Detector | SONTU50-4343S-CSONTU50-4343W-C/SONTU50-4336W-C/SONTU50-4336S-C | Trixell Pixium 3543EZH(MAX wi-D)iRay Mars1717VS (CoreXL)iRay Venu1717X (CoreStatic) | Similar.Proposed Device'sdetector was testedcompared with PredicateDevice's detector,verification and validationtesting concludedProposed Device'sdetector is equivalent toPredicate Device's detector's detector.All the flat panel detectorshave been tested withsystem. The system hasbeen tested and a riskanalysis performed. Thereis “No negative impact onsafety or efficacy” and nonew potential orincreased safety risksconcerning were raisedbecause of thisdifference. |
| Bucky wallstand | Motorized vertical module-Motorized vertical module | Manual or motorized verticalmodule- Motorized vertical module- Manual tilting module | Same.The motorized verticalmodule of the Bucky wallstand is exactly the samefor Proposed Device andPredicate Device. For costreduction reasons,proposed device is notequipped with manualmodule.This difference does notaffect the safety andeffectiveness of theproduct. |
| X-ray tubestand | Table mounted fully motorized- Motorized tube tilting- Motorized longitudinal- Motorized tube tilting | Floor mounted semi-motorized -- Manual tube tilting- Manual longitudinalmovementFloor mounted fully motorized- Manual tube tilting- Motorized tube lifting- Manual longitudinalmovement- Motorized tube tilting- Motorized longitudinal | SameThe Floor mounted fullymotorized of ProposedDevice and PredicateDevice are identical. |
| Patient Table | Fixed table with integrated railmounting tube stand wireless or wireddetector. | Elevating patient table with trayfor wireless or fixed detector | Similar.Fixed table and Elevatingpatient table arefunctionally identical. Fixedtable is more cost effectiveand better suited for thelower end of the market.This difference does notaffect the safety andeffectiveness of theproduct. |
| HumanMachineInterface(HMI) | No Smart Remote Control. | Smart Remote Control (SRC)supported by Siemens providedPhone that meets minimumrequirements. | Similar.Proposed Device is notequipped with SRCfunction due to lower costand low-end market.This difference does notaffect the safety andeffectiveness of theproduct. |
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Image /page/9/Picture/0 description: The image contains a logo for a medical imaging company called SONTU. The logo consists of a stack of colorful, rounded shapes on the left side, resembling stacked stones. To the right of the stacked stones is the company name, "SONTU," in bold, black letters. Below the company name, in smaller letters, is the phrase "Medical Imaging."
深圳市深图医学影像设备有限公司
Shenzhen SONTU Medical Imaging Equipment Co., LTD
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Image /page/10/Picture/0 description: The image contains the logo for SONTU Medical Imaging. The logo consists of a stack of rounded shapes in different colors 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. The rounded shapes are stacked with blue on top, followed by orange and yellow.
深圳市深图医学影像设备有限公司
Shenzhen SONTU Medical Imaging Equipment Co., LTD
Shenzhen SONTU Medical Imaging Equipment Co., LTD
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Image /page/11/Picture/0 description: The image contains the logo for SONTU Medical Imaging. The logo consists of a stack of overlapping circles in different shades of blue and orange on the left. To the right of the circles is the word "SONTU" in bold, black letters, with the words "Medical Imaging" in a smaller font size underneath.
圳市深图 矢字
Shenzhen SONTU Medical Imaging Equipment
8. PERFORMANCE DATA
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
Digital Radiography X-ray System conforms to the following standards:
- AAMI ES60601-1 IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION
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Image /page/12/Picture/0 description: The image contains the logo for SONTU Medical Imaging. The logo consists of a stack of overlapping circles in shades of blue and orange on the left, followed by the word "SONTU" in bold, black letters. Below "SONTU" is the phrase "Medical Imaging" in a smaller, lighter font.
圳市深峰 医学
Shenzhen SONTU Medical Imaging Equipment Co.
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- IEC 60601-1-2 2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-2-28 2017 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
- IEC60601-2-54 2022 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
- IEC 60601-1-3 2021 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
- IEC 60601-1-6 2020 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 60613:2010 Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis
- IEC 60336:2020 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics
- ASTM D4169-2022 Standard Practice for Performance Testing of Shipping Containers and Systems
- ANSI IEEE USEMCSC C63.27-2021 American National Standard for Evaluation of Wireless Coexistence
Proposed Sontu50 Flat panel detectors were tested with Effect Image Area, Linear Dose Range, Linear Dynamic Range, Spatial Resolution, Low Contrast Resolution, Flat Uniformity, Modulation Transfer Function, Detective Quantum Efficiency, Artifact, Erasure Thoroughness, which comparing with predicate device, and the comparison test verified that all the performance parameters of flat panel detector meet the requirements, and the performance parameters of proposed detector and predicate detector are the same. Additionally Conducting a concurrence evaluation on a certain number of clinical images from the same phantom or patients and reporting the results. The images are from different sites such as the chest, lumbar spine, elbow joint, knee joint, skull, pelvis, wrist joint, ankle joint, hand, and foot. The results show the ability of the device to provide images with equivalent diagnostic capability to those of the cleared predicate devices.
Software Documentation for a basic Level of Concern software per FDA's Guidance Document Guidance for the Content of Premarket Submissions for Device Software Functions, issued on June 14, 2023, is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests (integration and functional) were conducted on the Digital Radiography X-ray System during product development.
The risk analysis was completed and risk controls were implemented to mitigate identified hazards. The test results support that all the software specifications have met
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Image /page/13/Picture/0 description: The image contains the logo for SONTU Medical Imaging. The logo consists of a stack of six rounded shapes, with the top three in shades of blue and the bottom three in shades of orange. To the right of the stacked shapes is the word "SONTU" in a bold, sans-serif font. Below "SONTU" is the phrase "Medical Imaging" in a smaller, lighter font.
the acceptance criteria. Verification and validation testing were found acceptable to support the claim of substantial equivalence.
9. CLINICAL DATA
See the discussion in Section 8.
10. CONCLUSION
The indications for use statement for the subject device is similar to that of the predicate. The differences between the proposed device and its predicate device do not raise new issues of safety and effectiveness. The non-clinical data support the safety of the device and the performance testing report demonstrate that the Digital Radiography X-ray System should perform as intended in the specified use conditions.
From the results of non-clinical data including the performance testing described, Shenzhen SONTU Medical Imaging Equipment Co., Ltd. concludes that the Digital Radiography X-ray System is as safe, as effective, and performs as well as the legally marketed as the predicate devices (K213700 and K220919).
§ 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.