Combined High Frequency X-ray Source

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The full name reads "U.S. Food & Drug Administration". November 1, 2022 Suzhou Powersite Electric Co., Ltd. % Xinyue Lu Regulatory Engineer Building 5, No.188 Fuchunjiang Road, Suzhou New District Suzhou. Jiangsu Province 215151 CHINA # Re: K222258 Trade/Device Name: Combined High Frequency X-ray Source Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL Dated: July 18, 2022 Received: September 6, 2022 ## Dear Xinyue Lu: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K22258 Device Name Combined High Frequency X-ray Source #### Indications for Use (Describe) The Combined High Frequency X-ray Source is intended for use by a qualified/trained technician on both adult and pediatric subjects for body extremities and cervical spine exclusively. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography) Type of Use (Select one or both, as applicable): | <span style="font-size:10pt;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | |-------------------------------------------------------------------------------------| | <span style="font-size:10pt;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary ## 510(k) Submission Number: K222258 ### I. SUBMITTER Suzhou Powersite Electric Co., Ltd Building 5, No.188 Fuchunjiang Road, Suzhou New District, Suzhou, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA Phone: +86-0512-62913368 Contact Person: Yanyan Cui Phone: +86-13771842733 E-mail: may cui@powersite-group.com Primary correspondent Name: Xinyue Lu Title: Regulatory Engineer Phone: +86-13722611742 E-mail: xinyue lu@powersite-group.com Date Prepared: June 15, 2022 # II. DEVICE Name of Device: Combined High Frequency X-ray Source Model: PSM-PD5.6CPL, PSM-PD5.6CPLG, PSM-PD4CPL, PSM-PD4CPLG, PSM-PD3.5CPL, PSM-PD3.5CPLG, PSM-PD5.6CPE, PSM-PD5.6CPEG, PSM-PD4CPE, PSM-PD4CPEG, PSM-PD3.5CPE, PSM-PD3.5CPEG Common or Usual Name: Combined High Frequency X-ray Source Classification Name: System, X-Ray, Mobile (21 CFR 892.1720) Regulatory Class: II Product Code: IZL Regulation Medical Specialty: Radiology {4}------------------------------------------------ ## III. PREDICATE DEVICE Device Classification Name: system, x-ray, mobile 510(k) Number: K103522 Device Name: SEDECAL Proprietary-Trade Name: Sedecal SPL-HF-4.0 (and SPL-HF-2.0) Common/Usual Name: Mobile Diagnostic X-Ray System Applicant: SEDECAL S.A. 8870 RAVELLO NAPLES, FL 34114 Regulation Name and Number: 21 CFR 892.1720 Device Class: 2 Classification Product Code: IZL Requlation Medical Specialty: Radiology This predicate has not been subject to a design-related recall. No reference devices were used in this submission. # IV. DEVICE DESCRIPTION PSM-PD series combined high frequency X-ray source is an advanced high frequency X-ray source, which is mainly composed of shell case, control panel mounting assembly, DCDC riser mounting assembly, power panel mounting assembly, ESU energy storage capacitor mounting assembly, high voltage TANK, collimator, Lithium battery. The product is small in size, light in weight and high in power density, which can meet the needs of outdoor portability. At the same time, we provide battery-powered solutions to meet customers' diversified demands for product functions. The working flow of combined high-frequency X-ray source is as follows: Input single-phase alternating current, through the filter circuit, reduce the influence of 1) harmonics on mains power supply, APFC circuit will change AC into DC, improve the power factor of the product, through the filter circuit to reduce AC ripple. The DC inverter is converted into high-frequency alternating current by the inverter, and 2) the high-frequency low voltage is boosted into high-frequency high voltage by the boost transformer, and the AC is converted into high-voltage DC by the voltage multiplier, and finally the smooth high voltage is loaded at both ends of the ball tube through filtering. 3) Set different parameters and working modes through DSP+FPGA control unit. 4) Provide serial communication and wireless remote control functions. Provide LCD operation and upper computer software control of two parameters, working 5) mode setting. {5}------------------------------------------------ Our company provides Combined High Frequency X-ray Source to the complete machine manufacturer. Then the complete machine manufacturers assemble the complete machine with our product and sell the complete machine to the hospital or others. The associated consumables include: - . Mains power supply cord - . Hand switch control line - Serial port transfer wiring . - . Fuse(0215016.MXP) - Fuse(8020.0604) . - . Cross countersunk head screw(SUS304, M3*6) - Cross flat head screw(SUS304, M3*8, head diameter 6mm) . - USB flash disk . - Automatic test report . ## V. INDICATIONS FOR USE The Combined High Frequency X-ray Source is intended for use by a qualified/trained technician on both adult and pediatric subjects for body extremities and cervical spine exclusively. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography) The Indications for Use statement for the Powersite device is not identical to the predicate device; however, the differences do not alter the intended diagnostic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have the same intended use for X-ray photography of human limb joints and cervical spine in emergency rescue occasions, by cooperating with X-ray imaging device. # VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE # PREDICATE DEVICE At a high level, the subject and predicate devices are based on the following same technological elements: The working flow of combined high-frequency X-ray source is as follows: Input single-phase alternating current, through the filter circuit, reduce the influence of 1) harmonics on mains power supply, APFC circuit will change AC into DC, improve the power {6}------------------------------------------------ factor of the product, through the filter circuit to reduce AC ripple. 2) The DC inverter is converted into high-frequency alternating current by the inverter, and the high-frequency low voltage is boosted into high-frequency high voltage by the boost transformer, and the AC is converted into high-voltage DC by the voltage multiplier, and finally the smooth high voltage is loaded at both ends of the ball tube through filtering. 3) Set different parameters and working modes through DSP+FPGA control unit. 4) Provide serial communication and wireless remote control functions. Provide LCD operation and upper computer software control of two parameters, working 5) mode setting. {7}------------------------------------------------ The following technological differences exist between the subject and predicate devices: Table 1 Comparison Table | Comparison<br>item | The subject product | The predicate device(K103522) | Difference | Overview of<br>supporting<br>materials | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------| | Common/Usual<br>Name of Device | Combined High Frequency X-ray Source | Mobile Diagnostic X-ray System | SE | User manual | | Model<br>Specification | PSM-PD5.6CPL、PSM-PD5.6CPLG、<br>PSM-PD4CPL、PSM-PD4CPLG、<br>PSM-PD3.5CPL、PSM-PD3.5CPLG、<br>PSM-PD5.6CPE、PSM-PD5.6CPEG、<br>PSM-PD4CPE、PSM-PD4CPEG、<br>PSM-PD3.5CPE、PSM-PD3.5CPEG | Sedecal SPL-HF-4.0 (and SPL-HF-2.0) | SE | User manual | | Indications for<br>use | The Combined High Frequency X-ray<br>Source is intended for use by a<br>qualified/trained technician on both adult<br>and pediatric subjects for body extremities<br>and cervical spine exclusively. Applications<br>can be performed with the patient sitting,<br>standing, or lying in the prone or supine<br>position. (Not for mammography) | Intended for use by a qualified/trained<br>doctor or technician on both adult and<br>pediatric subjects for taking diagnostic<br>radiographic exposures of the skull,<br>spinal column, chest, abdomen,<br>extremities, and other body parts.<br>Applications can be performed with the<br>patient sitting, standing, or lying in the<br>prone or supine position. (Not for<br>mammography) | SE | User manual | | Basic principle<br>(Working | The working flow of combined high-<br>frequency X-ray source is as follows: | The working flow of combined high-<br>frequency X-ray source is as follows: | SE | User manual | | principle / Action mechanism) | | | | | | 1. Input single-phase alternating current,<br>through the filter circuit, reduce the<br>influence of harmonics on mains power<br>supply, APFC circuit will change AC into<br>DC, improve the power factor of the<br>product, through the filter circuit to reduce<br>AC ripple.<br>2. The DC inverter is converted into high-<br>frequency alternating current by the<br>inverter, and the high-frequency low voltage<br>is boosted into high-frequency high voltage<br>by the boost transformer, and the AC is<br>converted into high-voltage DC by the<br>voltage multiplier, and finally the smooth<br>high voltage is loaded at both ends of the<br>ball tube through filtering.<br>3. Set different parameters and working<br>modes through DSP+FPGA control unit.<br>4. Provide serial communication and<br>wireless remote control functions.<br>5. Provide LCD operation and upper<br>computer software control of two<br>parameters, working mode setting. | 1. Input single-phase alternating current,<br>through the filter circuit, reduce the<br>influence of harmonics on mains power<br>supply, APFC circuit will change AC into<br>DC, improve the power factor of the<br>product, through the filter circuit to<br>reduce AC ripple.<br>2. The DC inverter is converted into<br>high-frequency alternating current by the<br>inverter, and the high-frequency low<br>voltage is boosted into high-frequency<br>high voltage by the boost transformer,<br>and the AC is converted into high-<br>voltage DC by the voltage multiplier, and<br>finally the smooth high voltage is loaded<br>at both ends of the ball tube through<br>filtering.<br>3. Set different parameters and working<br>modes through DSP+FPGA control unit.<br>4. Provide serial communication and<br>wireless remote control functions.<br>5. Provide LCD operation and upper<br>computer software control of two<br>parameters, working mode setting. | Difference:<br>1) The structure | User manual | | | Structural composition | Combined High Frequency X-ray Source | The predicate device consists of the | | | | | product consists of the control software<br>(Release version: V1.0) and the host of<br>Combined High Frequency X-ray Source.<br><br>The host of Combined High Frequency X-ray Source is mainly composed of shell case, control panel mounting assembly, DCDC riser mounting assembly, power panel mounting assembly, ESU energy storage capacitor mounting assembly, high voltage TANK, collimator, Lithium battery. | control software and the host of<br>Combined High Frequency X-ray Source.<br><br>The host of the predicate device is composed of a control panel with a display, a power module, a high voltage tank (TANK), a collimator, a handswitch, and a mobile column with an articulated arm and a cassette basket. | composition is<br>different. The<br>predicate device is<br>accompanied with a<br>mobile column with<br>articulated arm and<br>cassette basket,<br>which the subject<br>device does not<br>have. | | | Basic parameter | 1. AC power input<br>100V~240VAC, ±10%<br>50Hz/60Hz±1Hz | 1. AC power input<br>100~240VAC, ±10% VAC,<br>50/60Hz | | User manual | | | 2. DC power input<br>48VDC/2A | 2. DC power input<br>48VDC/2A | | | | | | | | | {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ | 3. Maximum nominal electrical power<br>PSM-PD3.5CPL/CPLG<br>PSM-PD3.5CPE/CPEG<br>PSM-PD4CPL/CPLG<br>PSM-PD4CPE/CPEG<br>PSM-PD5.6 CPL/CPLG<br>PSM-PD5.6CPE/CPEG | 3.2kW<br>4.0kW<br>5.6kW | 3. Maximum nominal electrical power<br>SPL-HF4: 4kW | |----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 4. Maximum output electric power<br>PSM-PD3.5CPL/CPLG<br>PSM-PD3.5CPE/CPEG<br>PSM-PD4CPL/CPLG<br>PSM-PD4CPE/CPEG<br>PSM-PD5.6 CPL/CPLG<br>PSM-PD5.6CPE/CPEG | 3.6kW<br>4.0kW<br>5.6kW | 4. Output power:<br>SPL-HF4: 4kW | | | | Difference:<br>2) The maximum nominal electric power and the maximum output electric power are different. The maximum nominal electric power and the maximum output electric power in the model declared by the subject device are 5.6kW. While the maximum nominal electric power and the maximum output electric power in the model declared by the predicate device are 4kW. | {11}------------------------------------------------ | Normal<br>operating<br>condition | 1. Temperature:<br>0~35°C (AC supply )<br>0~40°C (only for battery discharging)<br>2. Relative humidity:<br>95%, non-condensing;<br>3. Atmospheric pressure:<br>700hPa~1060hPa. | 1. Temperature:<br>0~40°C<br>2. Relative humidity:<br>95%, non-condensing;<br>3. Atmospheric pressure:<br>700hPa~1060hPa. | SE | User manual | | | | | | | | | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|----|-------------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|-------------| | Performance<br>requirements | 1. X-ray tube voltage<br>a) Tube voltage regulation range:<br>40kV~125kV, 1kV step size, tube voltage<br>can be set according to power.<br>Model Tube voltage<br>regulation<br>range PSM-PD5.6CPL/CPLG<br>PSM-PD5.6CPE/CPEG<br>PSM-PD4CPL/CPLG<br>PSM-PD4CPE/CPEG<br>PSM-PD3.5CPL/CPLG 40kV~125kV | | | | | 1. X-ray tube voltage<br>a) Tube voltage regulation range:<br>40~125kV, 1kV step size.<br>Model Tube voltage<br>regulation range SPL-HF4 40~125kV<br>b) Tube voltage deviation: ±(3%+1kV) | | | | | | User manual | {12}------------------------------------------------ | PSM-PD3.5CPE/CPEG | | | | | |-----------------------------------------------------------|-------------------------------------|----------------------------------------------------------------------------------------------------|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | b) Tube voltage deviation:<br>$\pm$ (3%+1kV) | | | | | | 2. X-ray tube current<br>a) Tube current regulation range | | 2. X-ray tube current<br>a) Tube current regulation range | Difference: | | | Model | Tube current<br>regulation<br>range | Model | Tube current<br>regulation range | 3) The number systems<br>of tube current,<br>loading time and<br>current time product<br>are different. The<br>subject device is<br>distributed according<br>to the R'20 number<br>system, and the<br>predicate device is<br>distributed according<br>to the R'10 number<br>system and the user-<br>defined number<br>system. | | PSM-PD3.5CPL/CPLG | 5-63mA | SPL-HF4 | 5~100mA | | | PSM-PD3.5CPE/CPEG | | 16 steps, the specific data are: 5, 6.4, 8,<br>10, 12.5, 16, 20, 25, 32, 40, 50, 64, 80,<br>100 mA | | | | PSM-PD4CPL/CPLG | 5-80mA | | | | | PSM-PD4CPE/CPEG | | | | | | PSM-PD5.6CPL/CPLG | 5-100mA | b) Tube current deviation: | | | {13}------------------------------------------------ | PSM-PD5.6CPE | $\pm(4\% + 1 mA)$ | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Increasing according to the number system<br><br>R'20, the specific data are 5、5.6、6.3、<br>7.1、8、9、10、11、12.5、14、16、18、<br>20、22、25、28、32、36、40、45、50、<br>56、63、71、80、90、100。<br><br>b) Tube current deviation:<br>$\pm(4\% + 1 mA)$ | | | | | | | | 3. Loading time<br><br>a) Loading time regulation range:<br><br>1ms~10000ms,<br><br>Increasing according to the number system<br><br>R'20, the specific data are 1、1.1、1.25、<br>1.4、1.6、1.8、2、2.2、2.5、2.8、3.2、 | 3. Loading time<br><br>a) Loading time regulation range:<br><br>1 ms~10000ms,<br><br>Increase according to the number<br>system R'10 (in 25% steps), for a total of<br>41 steps | Difference:<br>4) The loading time<br>deviation is different.<br>The loading time<br>deviation of the<br>subject device is<br>larger than that of the<br>predicate device. The | | 3.6、4、4.5、5、5.6、6.3、7.1、8、9、<br>10、11、12.5、14、16、18、20、22、<br>25、28、32、36、40、45、50、56、63、<br>71、80、90、100、110、125、140、<br>160、180、200、220、250、280、320、<br>360、400、450、500、630、710、800、<br>900、1000、1100、1250、1400、1600、<br>1800、2000、2200、2500、2800、3200、<br>3600、4000、4500、5000、6300、7100、<br>8000、900、10000; | b) Loading time deviation:<br>$\pm$ (2% + 0.1ms) | deviation of the<br>subject device is<br>controlled within the<br>scope of the<br>international<br>standard<br>requirements. | | b) Loading time deviation:<br>not greater than<br>$\pm$ (2%+0.2ms) @ >5ms<br>$\pm$ (5%+1ms) @ ≤5ms | | | {14}------------------------------------------------ {15}------------------------------------------------ | 4. Current time product<br>a) Current time product regulation range: | 4. Current time product<br>a) Current time product regulation range: | Difference:<br>5) The regulation range of current time product is different. The regulation range of current time product of the subject device is larger than that of the predicate device. | | | | | | | | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--| | Model Current time product regulation range PSM-<br>PD3.5CPL/CPLG<br>PSM-<br>PD3.5CPE/CPEG<br>PSM-<br>PD4CPL/CPLG<br>PSM-<br>PD4CPE/CPEG<br>PSM-<br>PD5.6CPL/CPLG<br>PSM-<br>PD5.6CPE/CPEG 0.1-320mAs | | | | | Model Current time product regulation range SPL-HF4 0.1 mAs ~ 250 mAs Increase according to the number<br>system R'10 (in 25% steps), a total of 34 steps<br>b) Current time product deviation:<br>$\pm$ (5% + 0.1 mAs) | | | | | | {16}------------------------------------------------ | Increasing according to the number system | | | |-------------------------------------------|-----------------------------|--| | R'20, the specific data are 0.1、0.11、 | | | | 0.12、0.14、0.16、0.18、0.2、0.22、 | | | | 0.25、0.28、0.32、0.4、0.45、0.5、 | | | | 0.56、0.63、0.71、0.8、0.9、1、1.1、 | | | | 1.25、1.4、1.6、1.8、2、2.2、2.5、2.8、 | | | | 3.2、3.6、4、4.5、5、5.6、6.3、7.1、8、 | | | | 9、10、11、12.5、14、16、18、20、22、 | | | | 25、28、32、36、40、45、50、56、63、 | | | | 71、80、90、100、110、125、140、 | | | | 160、180、200、220、250、280、320。 | | | | b) Current time product deviation: | | | | ± (5% + 0.1 mAs) | | | | | | | | 5. Operating frequency: | 5. Operating frequency: | | | Maximum operating frequency | Maximum operating frequency | | | 300kHz±20kHz | 300kHz | | {17}------------------------------------------------ | Functional<br>requirements | 1. Exposure technology mode<br>The device should have mA/ms, mAs,<br>mAs/ms modes.<br>2. Fault diagnosis and prompt<br>1) During the exposure process, release the<br>handbrake actively, and an error should be<br>prompted.<br>2) If the internal temperature of the oil tank<br>of the combined head exceeds the limit, an<br>error should be prompted. | 1. Exposure technology mode<br>The device should have mA/ms, mAs<br>modes.<br>2. Fault diagnosis and prompt<br>All filament currents display values.<br>When the range is exceeded, the<br>exposure is not allowed, a continuous<br>alarm will sound and the value on the<br>display will flash. | SE | User manual | | |-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|-------------| | | Electrical safety | Shall comply with the requirements of IEC<br>60601-1 and IEC 60601-2-54. | Shall comply with the requirements of<br>IEC 60601-1 and IEC 60601-2-54. | SE | User manual | | | EMC | Shall comply with the requirements of IEC<br>60601-1-2. | Shall comply with the requirements of<br>IEC 60601-1-2. | SE | User manual | | | Software<br>requirements | 1. Basic data configuration<br>2. Exposure parameter setting | 1. Basic data configuration<br>2. Exposure parameter setting | SE | User manual | | | | | | | | | | It should be able to operate the software to<br>set the exposure mode, filament, tube<br>voltage, tube current, loading time and<br>current time product.<br>3. Information indication and fault prompt | It should be able to operate the software<br>to set the exposure mode, filament, tube<br>voltage, tube current, loading time and<br>current time product.<br>3. Information indication and fault<br>prompt | | | | | Cybersecurity<br>requirements | Data interface:<br>There is an RS-232 output interface, and<br>the RS-232 interface is used for the<br>communication between the Combined<br>High Frequency X-ray Source and the<br>control software of the client X-ray imaging<br>device to meet the interactive information. | None | Difference:<br>6) Cybersecurity<br>requirements are<br>different. The subject<br>device have been<br>tested and evaluated<br>for cybersecurity. We<br>have not found<br>information related to<br>cybersecurity about<br>the predicate device. | | | | | | | | User manual | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Sterilization /<br>disinfection<br>method | Not applicable | Not applicable | Neither<br>sterilization/disinfection is<br>required. | / | | {18}------------------------------------------------ {19}------------------------------------------------ There are 6 differences in comparison items between the subject device and the predicate device of the same type of medical devices: | No. | Different item | Difference description | Detailed description | |-----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------…