(121 days)
No
The summary describes a standard portable X-ray unit and its control software. There is no mention of AI, ML, or any features that would typically utilize these technologies for image analysis, processing beyond basic adjustments, or diagnostic assistance. The "image processing software" mentioned is likely standard software for viewing and manipulating digital X-ray images, not AI/ML-driven analysis.
No
The device is described as an X-ray unit intended for acquiring diagnostic images, not for treating diseases or conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The device may be used for handheld diagnostic imaging of body extremities." It also mentions its use for "diagnostic imaging of head, cervical spine, lumbar spine, pelvis or extremities" when stand-mounted.
No
The device description clearly states it is a portable digital device consisting of an X-ray main unit, exposure hand switch, and charger, all of which are hardware components. While it includes system control software, it is integral to the operation of the hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The SR-8100 Portable X-ray Unit is an imaging device that uses X-rays to create images of the internal structures of the body. It does not analyze biological samples.
- Intended Use: The intended use clearly states the purpose is "acquiring X-ray images of the desired parts of patient's anatomy" for "diagnostic imaging." This is a function of medical imaging, not in vitro diagnostics.
Therefore, the SR-8100 Portable X-ray Unit falls under the category of medical imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
The SR-8100 Portable X-ray Unit is a portable X-ray device, intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities). The device may be used for handheld diagnostic imaging of body extremities.
The system is subject to the following limitations of use when stand-mounted: The device may be used for diagnostic imaging of head, cervical spine, lumbar spine, pelvis or extremities. The device may be used for imaging of the chest when used without a grid.
This device is not to be used on bariatric patients, unless imaging body extremities. This device is not intended for mammography.
Product codes
IZL
Device Description
This SR-8100 Portable X-ray Unit is a portable digital device developed, designed and manufactured by SIUI. Its high-definition imaging and low-dose X-ray significantly minimize harm to patients and practitioners. The device consists of the following major components: an X-ray main unit, an exposure hand switch and a charger. The X-ray main unit is mainly for emitting X-rays required for X-ray exams; the hand switch is for output control of X-ray emitting, and the charger is for charging the built-in battery in the X-ray main unit.
The device can be used with an X-ray detector (see the table below for the basic requirements), a computer for receiving and detecting signal results and image processing software.
The major components of the X-ray main unit include: handle, enclosure, control panel, system control (SYS) board, high-voltage tank, collimator (beam limiter), lithium-ion battery and system control software running on the SYS board.
The system control software is for real-time interaction and control with various circuit modules inside the portable X-ray unit. The software responds to user operations on the control panel. The user can adjust and control the kV and mAs parameters, and the software will display the parameters or directly load the APR parameters. The software loads the control data from X-ray output into the high-voltage generation control circuit of the system control board, and control the high-voltage tank to generate high-voltage to excite the X-ray tube inside to emit X-rays, control the switch of the collimator indicator, and monitor the working status of the device, the battery power status, and control the display of the status indicators.
The system is for X-ray imaging and diagnosis in facilities with mobile or fixing sites. Since the kV range of this device is 40~100kVp, which is not suitable for breast exams, the device is not intended for mammography.
The wavelength of medical X-ray spectrum used by the portable X-ray unit SR-8100 shall have a range 0.001-0.1nm.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified/trained physician or technician
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
Not Found
Summary of Performance Studies
The non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the primary predicate.
Study Type: Non-clinical testing.
Sample Size: Not specified.
AUC: Not specified.
MRMC: Not specified.
Standalone Performance: Not specified.
Key Results: The device complies with IEC 60601-1, IEC60601-1-2, IEC60601-2-54, IEC60601-1-3, ISO 14971, ISO 10993-1, ISO 10993-5, ISO 10993-10, IEC 62304, IEC 60601-1-6, IEC 62366-1, ISO 15223-1, ISO 13485, and FDA guidance for software in medical devices. Test results showed compliance with these standards. Performance tests showed compliance with requirements of mobile X-ray system. Image quality tests, confirmed by a radiologist, meet clinical diagnostic requirements. The device runs stably without operating obstacles or failures.
Clinical testing is not necessary for the SR-8100 Portable X-ray unit in order to demonstrate substantial equivalence to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1720 Mobile x-ray system.
(a)
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.(b)
Classification. Class II.
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 logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) % Flower Cai Liaison Manager 77 Jinsha Road Shantou. Guangdong 515041 CHINA
Re: K200637
Trade/Device Name: SR-8100 Portable X-ray Unit Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL Dated: June 12, 2020 Received: June 15, 2020
Dear Flower Cai:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
July 9, 2020
1
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
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200637
Device Name SR-8100 Portable X-ray Unit
Indications for Use (Describe)
The SR-8100 Portable X-ray Unit is a portable X-ray device, intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities). The device may be used for handheld diagnostic imaging of body extremities.
The device may be used for handheld diagnostic imaging of body extremities.
The system is subject to the following limitations of use when stand-mounted: The device may be used for diagnostic imaging of head, cervical spine, lumbar spine, pelvis or extremities. The device may be used for imaging of the chest when used without a grid.
This device is not to be used on bariatric patients, unless imaging body extremities. This device is not intended for mammography.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
This summary of 510(k) safety and effectiveness information is provided in accordance with the requirements of SMDA 1990 and 21 CFR 807.92(c).
The assigned 510(k) number is: K200637
Submitter 5.1
Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI)
77 Jinsha Road, Shantou, Guangdong 515041, China
Tel: 86-754-88250150
Fax: 86-754-88251499
Contact Person: Flower Cai
Shantou Institute of Ultrasonic Instruments Co., Ltd.
77 Jinsha Road, Shantou, Guangdong 515041, China
Date Prepared: June 12, 2020
5.2 Device
Name of Device: SR-8100 Portable X-ray Unit
Classification Name: Mobile x-ray system (21 CFR 892.1720)
Regulatory Class: II
Product Code: IZL
Predicate Device 5.3
The SR-8100 Portable X-ray Unit is for X-ray imaging, diagnosis and image acquisition with mobile or fixing sites, and is substantially equivalent to the predicate device:
4
| Legally Marketed
Device | Manufacturer | Model | 510(k) Control
Number |
|-----------------------------|-------------------|-------------------|--------------------------|
| Primary
predicate device | MinXray, Inc | TR90BH | K182207 |
| Reference device | DRGEM Corporation | JADE Mobile X-Ray | K183388 |
The reference device is for comparing the collimator parameters and output rating parameters of the portable X-ray units.
5.4 Device Description
This SR-8100 Portable X-ray Unit is a portable digital device developed, designed and manufactured by SIUI. Its high-definition imaging and low-dose X-ray significantly minimize harm to patients and practitioners. A detailed comparison table with an equivalent device is provided below. The device consists of the following major components: an X-ray main unit, an exposure hand switch and a charger. The X-ray main unit is mainly for emitting X-rays required for X-ray exams; the hand switch is for output control of X-ray emitting, and the charger is for charging the built-in battery in the X-ray main unit. See the photos below.
The device can be used with an X-ray detector (see the table below for the basic requirements), a computer for receiving and detecting signal results and image processing software.
The detector that can be used with SR-8100 shall comply with the following basic conditions:
| Acceptable minimum X-ray range | 40kV-100kV |
|---|---|
| Image Sensor | a-Si (Amorphous Silicon) TFT |
| Minimum Effective Array | 2304 x 2800 |
| Minimum Effective Area (H x V) | 343 x 416 mm |
| Software | Configured with a basic imaging test tool |
| for image acquisition and display |
The major components of the X-ray main unit include: handle, enclosure, control panel, system control (SYS) board, high-voltage tank, collimator (beam limiter), lithium-ion battery and system control software running on the SYS board.
5
SIUI SR-8100 Portable X-ray Unit
The system control software is for real-time interaction and control with various circuit modules inside the portable X-ray unit. The software responds to user operations on the control panel. The user can adjust and control the kV and mAs parameters, and the software will display the parameters or directly load the APR parameters. The software loads the control data from X-ray output into the high-voltage generation control circuit of the system control board, and control the high-voltage tank to generate high-voltage to excite the X-ray tube inside to emit X-rays, control the switch of the collimator indicator, and monitor the working status of the device, the battery power status, and control the display of the status indicators.
Image /page/5/Picture/2 description: The image shows an X-ray main unit with several labeled components. The components labeled are the handle, control panel, enclosure, and collimator. The X-ray main unit is light blue and white and has a handle on top for easy transport.
The system is for X-ray imaging and diagnosis in facilities with mobile or fixing sites. Since the kV range of this device is 40~100kVp, which is not suitable for breast exams, the device is not intended for mammography.
The wavelength of medical X-ray spectrum used by the portable X-ray unit SR-8100 shall have a range 0.001-0.1nm.
6
Indications for Use ર્સ રાજ્યના સાથે તેમની સાથે તેમની સાથે છે. આ ગામનાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂ
The SR-8100 Portable X-ray Unit is a portable X-ray device, intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).
The device may be used for handheld diagnostic imaging of body extremities.
The system is subject to the following limitations of use when stand-mounted: The device may be used for diagnostic imaging of head, cervical spine, abdomen, lumbar spine, pelvis or extremities.
The device may be used for imaging of the chest when used without a grid.
This device is not to be used on bariatric patients, unless imaging body extremities. This device is not intended for mammography.
5.6 Comparison of Technological Characteristics with the Predicate Device
The comparison between the overall specifications of predicate device (TR90BH) and the new device (SR-8100) is shown in table 1, and the comparison between the Collimator specifications of reference device (JADE Mobile X-ray) and the new device (SR-8100) is shown in table 2. Any differences between the predicate and the new device have no impact on safety or efficacy of the new device and do not raise any new potential or increased safety risks, and the new device is equivalent in performance to existing legally marketed devices.
7
Table 1 Subject and Predicate (TR90BH) Device Comparison
8
| Description | Subject Device
SR-8100 | Predicate Device
TR90BH (K182207) |
|---------------------------|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comment on
Indications | Original Indications | Certain limitations apply because of the lower maximum kVp output as compared to the predicate and because of the possibility of handheld use on extremities. See indications above. |
| Weight | 12kgs (26.46lb)
(Including Collimator) | 7.5kgs (16.53lb)
(Including Collimator) |
| Size | 227mm×522mm×217mm | 219 mm x 442 mm x 190 mm |
| Energy Source | Lithium-ion Rechargeable
Battery (29.6V DC),
300 exposures per charge | Lithium-ion Rechargeable Battery
(57.6VDC),
300 exposures per charge. |
| Use Interface | Soft touch push buttons | Soft touch push buttons |
| Exposure times | 0.02 sec – 2.5 sec: R'10 sec
Step | 0.01 sec - 1.0 sec :0.01 sec Step
High Power Mode
0.01 sec – 0.3 sec:0.01 sec Step |
| mA | 25 mA @ 40kVDC – 60kVDC (1kVP steps)
20 mA @ 61kVDC – 100kVDC (1kVP steps) | 20 mA @ 40kVDC – 60kVDC (2kVP steps)
15 mA @ 62kVDC – 80kVDC (2kVP steps)
10 mA @ 82kVDC – 90kVDC (2kVP steps)
High Power Mode
15 mA @ 82kVDC – 90kVDC (2kVP steps)
0.02 Comment: 90 kVP maximum instead of 120 kVP maximum. |
9
SIUI SR-8100 Portable X-ray Unit
| Description | Subject Device
SR-8100 | Predicate Device
TR90BH (K182207) |
|--------------------------------|---------------------------|--------------------------------------|
| Memory Settings
(technique) | 5 memories via pushbutton | 5 memories via pushbutton |
| HF Generator | High Frequency | High Frequency |
| kW | 2.0kW | 1.35kW |
| kVp | 40-100kVp | 40-90kVp |
| X-ray Tube | D-125SB | D-0814 |
| FDA
Performance
Standard | Complies | Complies |
| Collimator | SIUI SR-8100-19L | Mikasa BLD34L |
Table 2 Subject and Reference Device (JADE-32) Comparison
| Table 2 Subject and Reference Device (JADE-32) Comparison | ||
|---|---|---|
| Description | Subject Device | Reference Device |
| SR-8100 | JADE-32 (K183388) | |
| Output Rating | Max. 2.0kW(20mA@100kV) | Max. 3.2kW(40mA@ 80kV, |
| 32mA@100kV,25mA@120kV) | ||
| Type | Microprocessor controlled | |
| High Frequency inverter | Microprocessor controlled High | |
| Frequency inverter | ||
| kV Range | 40~100kV,61 Step (1kV Step) | 40~120kV,81 Step (1kV Step) |
| mA Range | 20~25mA, 2 Step | |
| (20,25mA) | 10~80mA, 10 Step | |
| (10,12.5,16,20,25,32,40,50,64,80mA) | ||
| Exposure Time | 0.02~2.5 seconds, | |
| 21 Step (in 25% Steps) | 0.01~10 seconds, | |
| 21 Step (in 25% Steps) | ||
| mAs Range | 0.4~50mAs, | |
| 35 Step ( in 25% Steps) | 0.1~250mAs, | |
| 35 Step ( in 25% Steps) | ||
| X-ray Tube Type | Stationary Anode | Stationary Anode |
| Focal Spot Size | ||
| (Small/Large) | 1.2mm | 0.5/1.5mm |
| Anode Heat Storage Capacity | 50,000HU (35,000J) | 56,000HU (40,000J) |
10
SIUI SR-8100 Portable X-ray Unit
| Description | Subject Device
SR-8100 | Reference Device
JADE-32 (K183388) |
|----------------------------------------|------------------------------------------------|------------------------------------------------|
| Power Cord
Length | 3m | 5m |
| Exposure
Hand-switch
Cord Length | 3m (Max. Length) | 5m (Max. Length) |
| X-ray switching
frequency | 100kHz | 100kHz |
| Control | 2 Point Control (kV, mAs) | 2 Point Control (kV, mAs) |
| Anatomical
Programs | Preprogrammed 9 APR data-
User Programmable | Preprogrammed 9 APR data-
User Programmable |
Table 3 Collimator Specs Comparison
| Description | Subject Device
SIUI SR-8100 | Reference Device
DRGEM JADE Mobile X-Ray
System (K183388) |
|------------------------|-------------------------------------------------------|-----------------------------------------------------------------|
| Model | SR-8100-19L | KM1 |
| Manufacturer | SIUI | DRGEM |
| Control | Manual
with 15,
30,
45,
60sec. Lamp timer | Manual with 15, 30, 45, 60sec.
Lamp timer |
| Field Shape | Rectangular | Rectangular |
| Max. Field Size | 44x44cm (at 100cm SID) | 44x44cm (at 100cm SID) |
| Leakage
Radiation |