(137 days)
Not Found
No
The document does not mention AI, ML, or related terms like deep learning or neural networks. The software is described as "Basic level of concern" and the performance studies focus on image quality metrics and equivalence to predicate devices, not AI/ML performance metrics.
No.
The device is used for generating diagnostic images (diagnosing conditions) not for treating diseases or conditions.
Yes
The "Intended Use / Indications for Use" section states: "The Digital radiography X-ray system uses digital detectors for generating diagnostic images by converting X-rays into image signals." Also, "Summary of Performance Studies" mentions "equivalent diagnostic capability."
No
The device description explicitly lists hardware components such as a ceiling suspension with an X-ray tube, Bucky wall stand, Bucky table, X-ray generator, and detectors, indicating it is a hardware system with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a "Digital radiography X-ray system." It uses X-rays to generate images of the internal structures of the body.
- Intended Use: The intended use is for "radiographic exposures of the whole body" to produce "diagnostic images." This involves imaging the patient directly, not analyzing samples taken from the patient.
The device operates by interacting with the patient's body using radiation, not by analyzing biological samples in a laboratory setting. Therefore, it falls under the category of medical imaging devices, not IVDs.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KPR, MQB
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.
Mentions image processing
The Digital radiography X-ray system uses digital detectors for generating diagnostic images by converting X-rays into image signals.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
skull, chest, abdomen, and extremities
Indicated Patient Age Range
adult and bariatric patients
Intended User / Care Setting
hospitals, clinics, and medical practices.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- AAMI ES60601-1 IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION 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 the acceptance criteria. Verification and validation testing were found acceptable to support the claim of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
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:
-
- 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
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:40kV150kV630mA
Current:10mA
Current time
product:0.1mAs1000mAs10000ms | /(50/60Hz)
Exposure time:1ms
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:40kV150kV630mA
Current:10mA
Current time product:0.1mAs1000m10000ms | Polydoros RFX
mAs
Exposure time:1ms
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 potential or
increased safety risks
concerning were raised
because of this
difference. |
| Bucky wall
stand | Motorized vertical module
-Motorized vertical module | Manual or motorized vertical
module - Motorized vertical module
- Manual tilting module | Same.
The motorized vertical
module of the Bucky wall
stand is exactly the same
for Proposed Device and
Predicate Device. For cost
reduction reasons,
proposed device is not
equipped with manual
module.
This difference does not
affect the safety and
effectiveness of the
product. |
| X-ray tube
stand | Table mounted fully motorized - Motorized tube tilting
- Motorized longitudinal
- Motorized tube tilting | Floor mounted semi-motorized -
- Manual tube tilting
- Manual longitudinal
movement
Floor mounted fully motorized - Manual tube tilting
- Motorized tube lifting
- Manual longitudinal
movement - Motorized tube tilting
- Motorized longitudinal | Same
The Floor mounted fully
motorized of Proposed
Device and Predicate
Device are identical. |
| Patient Table | Fixed table with integrated rail
mounting tube stand wireless or wired
detector. | Elevating patient table with tray
for wireless or fixed detector | Similar.
Fixed table and Elevating
patient table are
functionally identical. Fixed
table is more cost effective
and better suited for the
lower end of the market.
This difference does not
affect the safety and
effectiveness of the
product. |
| Human
Machine
Interface
(HMI) | No Smart Remote Control. | Smart Remote Control (SRC)
supported by Siemens provided
Phone that meets minimum
requirements. | Similar.
Proposed Device is not
equipped with SRC
function due to lower cost
and low-end market.
This difference does not
affect the safety and
effectiveness of the
product. |
9
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
10
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
11
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
12
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
13
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).