← Product Code [IZL](/productcode/IZL) · K222258 # Combined High Frequency X-ray Source (K222258) _Suzhou Powersite Electric Co., Ltd. · IZL · Nov 1, 2022 · Radiology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K222258 ## Device Facts - **Applicant:** Suzhou Powersite Electric Co., Ltd. - **Product Code:** [IZL](/productcode/IZL.md) - **Decision Date:** Nov 1, 2022 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1720 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Pediatric ## 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) ## Device Story Combined High Frequency X-ray Source (PSM-PD series) functions as an X-ray generator component for integration into complete mobile X-ray systems. Input: single-phase AC power. Operation: filter circuit reduces harmonics; APFC circuit converts AC to DC; inverter creates high-frequency AC; boost transformer and voltage multiplier generate high-voltage DC for the X-ray tube. Controlled via DSP+FPGA unit; supports serial communication and wireless remote control. Output: high-voltage power for X-ray tube. Used in clinical/emergency settings by qualified technicians. Healthcare providers use the device as part of a larger imaging system to obtain diagnostic radiographs. Benefits include portable, battery-powered X-ray generation for extremity and cervical spine imaging. ## Clinical Evidence No clinical data provided. Substantial equivalence supported by bench testing, including electrical safety, EMC, software verification/validation, and mechanical/acoustic testing. Device is an X-ray generator component; clinical images deemed unnecessary for equivalence determination. ## Technological Characteristics High-frequency X-ray source; components include shell, control panel, DCDC riser, power panel, ESU energy storage capacitor, high voltage tank, collimator, Lithium battery. Materials: SUS304 (screws). Power: 100-240VAC or 48VDC. Connectivity: RS-232 interface for imaging system integration. Control: DSP+FPGA unit. Standards: IEC 60601-1, IEC 60601-1-3, IEC 60601-2-54, IEC 60601-1-2. ## Regulatory Identification A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. ## Predicate Devices - SEDECAL SPL-HF-4.0 (and SPL-HF-2.0) ([K103522](/device/K103522.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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): | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |-------------------------------------------------------------------------------------| | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary ## 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
item | The subject product | The predicate device(K103522) | Difference | Overview of
supporting
materials | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------| | Common/Usual
Name of Device | Combined High Frequency X-ray Source | Mobile Diagnostic X-ray System | SE | User manual | | Model
Specification | 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 | Sedecal SPL-HF-4.0 (and SPL-HF-2.0) | SE | User manual | | 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) | Intended for use by a qualified/trained
doctor or technician on both adult and
pediatric subjects for taking diagnostic
radiographic exposures of the skull,
spinal column, chest, abdomen,
extremities, and other body parts.
Applications can be performed with the
patient sitting, standing, or lying in the
prone or supine position. (Not for
mammography) | SE | User manual | | Basic principle
(Working | The working flow of combined high-
frequency X-ray source is as follows: | The working flow of combined high-
frequency X-ray source is as follows: | SE | User manual | | principle / Action mechanism) | | | | | | 1. Input single-phase alternating current,
through the filter circuit, reduce the
influence of 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.
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.
5. Provide LCD operation and upper
computer software control of two
parameters, working mode setting. | 1. Input single-phase alternating current,
through the filter circuit, reduce the
influence of 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.
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.
5. Provide LCD operation and upper
computer software control of two
parameters, working mode setting. | Difference:
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
(Release version: V1.0) and the host of
Combined High Frequency X-ray Source.

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
Combined High Frequency X-ray Source.

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
different. The
predicate device is
accompanied with a
mobile column with
articulated arm and
cassette basket,
which the subject
device does not
have. | | | Basic parameter | 1. AC power input
100V~240VAC, ±10%
50Hz/60Hz±1Hz | 1. AC power input
100~240VAC, ±10% VAC,
50/60Hz | | User manual | | | 2. DC power input
48VDC/2A | 2. DC power input
48VDC/2A | | | | | | | | | {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ | 3. Maximum nominal electrical power
PSM-PD3.5CPL/CPLG
PSM-PD3.5CPE/CPEG
PSM-PD4CPL/CPLG
PSM-PD4CPE/CPEG
PSM-PD5.6 CPL/CPLG
PSM-PD5.6CPE/CPEG | 3.2kW
4.0kW
5.6kW | 3. Maximum nominal electrical power
SPL-HF4: 4kW | |----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 4. Maximum output electric power
PSM-PD3.5CPL/CPLG
PSM-PD3.5CPE/CPEG
PSM-PD4CPL/CPLG
PSM-PD4CPE/CPEG
PSM-PD5.6 CPL/CPLG
PSM-PD5.6CPE/CPEG | 3.6kW
4.0kW
5.6kW | 4. Output power:
SPL-HF4: 4kW | | | | Difference:
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
operating
condition | 1. Temperature:
0~35°C (AC supply )
0~40°C (only for battery discharging)
2. Relative humidity:
95%, non-condensing;
3. Atmospheric pressure:
700hPa~1060hPa. | 1. Temperature:
0~40°C
2. Relative humidity:
95%, non-condensing;
3. Atmospheric pressure:
700hPa~1060hPa. | SE | User manual | | | | | | | | | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|----|-------------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|-------------| | Performance
requirements | 1. X-ray tube voltage
a) Tube voltage regulation range:
40kV~125kV, 1kV step size, tube voltage
can be set according to power.
Model Tube voltage
regulation
range PSM-PD5.6CPL/CPLG
PSM-PD5.6CPE/CPEG
PSM-PD4CPL/CPLG
PSM-PD4CPE/CPEG
PSM-PD3.5CPL/CPLG 40kV~125kV | | | | | 1. X-ray tube voltage
a) Tube voltage regulation range:
40~125kV, 1kV step size.
Model Tube voltage
regulation range SPL-HF4 40~125kV
b) Tube voltage deviation: ±(3%+1kV) | | | | | | User manual | {12}------------------------------------------------ | PSM-PD3.5CPE/CPEG | | | | | |-----------------------------------------------------------|-------------------------------------|----------------------------------------------------------------------------------------------------|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | b) Tube voltage deviation:
$\pm$ (3%+1kV) | | | | | | 2. X-ray tube current
a) Tube current regulation range | | 2. X-ray tube current
a) Tube current regulation range | Difference: | | | Model | Tube current
regulation
range | Model | Tube current
regulation range | 3) The number systems
of tube current,
loading time and
current time product
are different. The
subject device is
distributed according
to the R'20 number
system, and the
predicate device is
distributed according
to the R'10 number
system and the user-
defined number
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,
10, 12.5, 16, 20, 25, 32, 40, 50, 64, 80,
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

R'20, the specific data are 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。

b) Tube current deviation:
$\pm(4\% + 1 mA)$ | | | | | | | | 3. Loading time

a) Loading time regulation range:

1ms~10000ms,

Increasing according to the number system

R'20, the specific data are 1、1.1、1.25、
1.4、1.6、1.8、2、2.2、2.5、2.8、3.2、 | 3. Loading time

a) Loading time regulation range:

1 ms~10000ms,

Increase according to the number
system R'10 (in 25% steps), for a total of
41 steps | Difference:
4) The loading time
deviation is different.
The loading time
deviation of the
subject device is
larger than that of the
predicate device. The | | 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、
360、400、450、500、630、710、800、
900、1000、1100、1250、1400、1600、
1800、2000、2200、2500、2800、3200、
3600、4000、4500、5000、6300、7100、
8000、900、10000; | b) Loading time deviation:
$\pm$ (2% + 0.1ms) | deviation of the
subject device is
controlled within the
scope of the
international
standard
requirements. | | b) Loading time deviation:
not greater than
$\pm$ (2%+0.2ms) @ >5ms
$\pm$ (5%+1ms) @ ≤5ms | | | {14}------------------------------------------------ {15}------------------------------------------------ | 4. Current time product
a) Current time product regulation range: | 4. Current time product
a) Current time product regulation range: | Difference:
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-
PD3.5CPL/CPLG
PSM-
PD3.5CPE/CPEG
PSM-
PD4CPL/CPLG
PSM-
PD4CPE/CPEG
PSM-
PD5.6CPL/CPLG
PSM-
PD5.6CPE/CPEG 0.1-320mAs | | | | | Model Current time product regulation range SPL-HF4 0.1 mAs ~ 250 mAs Increase according to the number
system R'10 (in 25% steps), a total of 34 steps
b) Current time product deviation:
$\pm$ (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
requirements | 1. Exposure technology mode
The device should have mA/ms, mAs,
mAs/ms modes.
2. Fault diagnosis and prompt
1) During the exposure process, release the
handbrake actively, and an error should be
prompted.
2) If the internal temperature of the oil tank
of the combined head exceeds the limit, an
error should be prompted. | 1. Exposure technology mode
The device should have mA/ms, mAs
modes.
2. Fault diagnosis and prompt
All filament currents display values.
When the range is exceeded, the
exposure is not allowed, a continuous
alarm will sound and the value on the
display will flash. | SE | User manual | | |-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|-------------| | | Electrical safety | Shall comply with the requirements of IEC
60601-1 and IEC 60601-2-54. | Shall comply with the requirements of
IEC 60601-1 and IEC 60601-2-54. | SE | User manual | | | EMC | Shall comply with the requirements of IEC
60601-1-2. | Shall comply with the requirements of
IEC 60601-1-2. | SE | User manual | | | Software
requirements | 1. Basic data configuration
2. Exposure parameter setting | 1. Basic data configuration
2. Exposure parameter setting | SE | User manual | | | | | | | | | | It should be able to operate the software to
set the exposure mode, filament, tube
voltage, tube current, loading time and
current time product.
3. Information indication and fault prompt | It should be able to operate the software
to set the exposure mode, filament, tube
voltage, tube current, loading time and
current time product.
3. Information indication and fault
prompt | | | | | Cybersecurity
requirements | Data interface:
There is an RS-232 output interface, and
the RS-232 interface is used for the
communication between the Combined
High Frequency X-ray Source and the
control software of the client X-ray imaging
device to meet the interactive information. | None | Difference:
6) Cybersecurity
requirements are
different. The subject
device have been
tested and evaluated
for cybersecurity. We
have not found
information related to
cybersecurity about
the predicate device. | | | | | | | | User manual | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Sterilization /
disinfection
method | Not applicable | Not applicable | Neither
sterilization/disinfection is
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 | |-----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------… --- **Source:** [https://fda-staging.innolitics.com/device/K222258](https://fda-staging.innolitics.com/device/K222258) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com