(183 days)
No reference devices were used in this submission.
No
The device description focuses on the hardware components and basic control software for adjusting X-ray parameters. There is no mention of AI, ML, or advanced image processing capabilities. The software described is for real-time interaction and control of the generator, not for image analysis or interpretation.
No.
The device is used for diagnostic imaging, not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use by a qualified/trained physician or technician for handheld diagnostic imaging of body extremities." Additionally, the "Summary of Performance Studies" mentions that image quality evaluation was performed on test images and found to be of "excellent diagnostic quality," which implies a diagnostic purpose.
No
The device description explicitly lists hardware components such as an LED display, X-ray generator, X-ray tube assembly, and collimator, in addition to the system control software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The iQFlex Pro Mobile X-ray System is used for diagnostic imaging of the human body using X-rays. It directly interacts with the patient to produce images, rather than analyzing samples taken from the patient.
- Intended Use: The intended use clearly states "handheld diagnostic imaging of body extremities" and "stand mounted diagnostic imaging of head, abdomen, or extremities" and "stand mounted imaging of the chest." This describes an imaging modality, not an in vitro test.
Therefore, the iQFlex Pro Mobile X-ray System is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The iQFlex Pro Mobile X-ray System is a medical device intended for use by a qualified/trained physician or technician for handheld diagnostic imaging of body extremities. The device may be used for stand mounted diagnostic imaging of head, abdomen, or extremities. The device may be used for stand mounted imaging of the chest. - Not to be used on bariatric patients, unless imaging body extremities. Not for mammography use.
Not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.
Product codes
IZL
Device Description
This Mobile X-ray System (Model: iQFlex Pro) consists of a LED display with up and down soft-keys for controlling kVp, an X-ray generator, an X-ray tube assembly, and a collimator. In addition, this unit has preset memory keys to store and select kVp/mAs. The iQFlex Pro can be used with a flat panel detector of choice. The subject device iQFlex Pro is not being provided with digital detectors. This device is a battery-powered mobile X-ray system, designed and manufactured by First Source Inc. Compared with traditional X-ray products, this device has exquisite structure, compact design, light weight and easy operation. The major components of the X-ray main unit include: handle, enclosure, main/sub console board, high-voltage tank, inverter, collimator (beam limiter), and system control software running on the main console board. The system control software is for real-time interaction and control with various circuit modules inside the X-ray generator. The software responds to user operations on the main console board. The user can adjust and control the kVp 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 inverter, 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, and control the display of the status indicators. The system is for X-ray imaging and diagnosis in medical facilities with mobile or fixed sites. The iQFlex Pro is not intended for mammography. Detectors are recommended but not provided with the iQFlex system. Detectors chosen must have been cleared by FDA have reasonable MTF and DQE values. The iQFlex Pro is not a cybersecurity device, however it has firmware and a USB-C port. The USB-C port is for battery charging only. The iQFlex Pro generator doesn't connect to the Internet, to other medical devices, and the supporting software doesn't offer a protocol for transfer of medical data.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
body extremities, head, abdomen, chest
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified/trained physician or technician; medical facilities with mobile or fixed sites
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
Nonclinical (bench) testing: The performance characteristics and operation / usability of the iQFlex Pro were evaluated. These studies demonstrated intended workflow, related performance, overall function, shipping performance, verification and validation of requirements for intended use, and reliability of the system including both software requirements. Predefined acceptance criteria were met.
Electrical safety and electromagnetic compatibility (EMC) testing: Conducted in compliance to IEC 60601-1:2005/AMD1:2012 and IEC 60601-1-2:2014, performed for both Class B environments.
Software Verification and Validation Testing: Conducted and documentation provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device is considered to present a "moderate" level of concern.
Image Quality Evaluation: Test images of the head, chest, abdomen, and extremities were obtained to assure diagnostic quality. The images were evaluated by a Board Certified Radiologist and found to be of excellent diagnostic quality.
Clinical Studies: A limited clinical test was performed to demonstrate that the device could image anatomy other than extremities. A Board Certified Radiologist performed a successful review.
Key results: Non-clinical test results have demonstrated that the device conforms to its specifications. Test results have demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
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
July 3, 2024
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font below.
First Source Inc. % Daniel Kamm, P.E. Kamm and Associates 8870 Ravello Ct. NAPLES, FL 34114
Re: K240009
Trade/Device Name: iOFlex Pro Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: Class II Product Code: IZL Dated: November 15, 2023 Received: June 6, 2024
Dear Mr. Kamm:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-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,
Lu Jiang
Lu Jiang, 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
2
Indications for Use
510(k) Number (if known) K240009
Device Name iQFlex Pro
Indications for Use (Describe)
The iQFlex Pro Mobile X-ray System is a medical device intended for use by a qualified/trained physician or technician for handheld diagnostic imaging of body extremities. The device may be used for stand mounted diagnostic imaging of head, abdomen, or extremities. The device may be used for stand mounted imaging of the chest. - Not to be used on bariatric patients, unless imaging body extremities. Not for mammography use.
Not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types
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) | ☐ |
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3
Image /page/3/Picture/0 description: The image shows the logo for 1st Source. The logo is a white circle with the words "1st SOURCE" in bold, teal letters. The number "1st" is stacked on top of the word "SOURCE". There is a teal crescent shape that wraps around the bottom of the circle. Below the logo, the text "510(k) Summary K240009" is written.
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
SUBMITTER 1)
First Source Inc. Address: 3495 Winton Place, Building E, Suite 1, Rochester, NY 14623 Phone: 585.272.1690, Toll Free: 800.349.5980, Fax: 585.272.7678 https://1stsourceimaging.com Email: rviola@fsimed.com Contact Person: Ronald Viola Position: President Date Prepared: July 3, 2024
2) DEVICE
Name of Device: iQFlex Pro Regulation Name: Mobile X-ray system Regulation Number: 892.1720 Regulatory Class: II Product Code: IZL
3) PREDICATE DEVICE
MinXray Inc. K182207 Name of Device: MinXray, MODEL TR90BH Regulation Name: Mobile X-ray system Regulation Number: 21 CFR 892.1720 Regulatory Class: II Primary Product Code: IZL This predicate has not been subject to a design-related recall. No reference devices were used in this submission.
- DEVICE DESCRIPTION. This Mobile X-ray System (Model: iQFlex Pro) consists of a LED display with up and down soft-keys for controlling kVp, an X-ray generator, an X-ray tube assembly, and a collimator. In addition, this unit has preset memory keys to store and select kVp/mAs. The iQFlex Pro can be used with a flat panel detector of choice. The subject device iQFlex Pro is not being provided with digital detectors. This device is a battery-powered mobile X-ray system, designed and manufactured by First Source Inc. Compared with traditional X-ray products, this device has exquisite structure, compact design, light weight and easy operation. The major components of the X-ray main unit include: handle, enclosure, main/sub console board, high-voltage tank, inverter, collimator (beam limiter), and system control software running on the main console board. The system control software is for real-time interaction and control with various circuit modules inside the X-ray generator. The software responds to user operations on the main console board. The user can adjust and control the kVp 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 inverter, 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
4
indicator, and monitor the working status of the device, and control the display of the status indicators. The system is for X-ray imaging and diagnosis in medical facilities with mobile or fixed sites. The iQFlex Pro is not intended for mammography. Detectors are recommended but not provided with the iQFlex system. Detectors chosen must have been cleared by FDA have reasonable MTF and DQE values. The iQFlex Pro is not a cybersecurity device, however it has firmware and a USB-C port. The USB-C port is for battery charging only. The iQFlex Pro generator doesn't connect to the Internet, to other medical devices, and the supporting software doesn't offer a protocol for transfer of medical data.
-
- INDICATIONS FOR USE. The iQFlex Pro Mobile X-ray System is a medical device intended for use by a qualified/trained physician or technician for handheld diagnostic imaging of body extremities The device may be used for stand mounted diagnostic imaging of head, abdomen, or extremities. The device may be used for stand mounted imaging of the chest - Not to be used on bariatric patients, unless imaging body extremities. Not for mammography use. Not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.
- The comparison between the overall specifications of predicate device (MinXray TR90BH) and the subject device (iQFlex Pro) is shown in Table 1.
| Item | Predicate Device MinXray TR90BH
(K182207) | Subject Device iQFlex Pro (without digital
imaging) |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use: | The TR90BH is a portable X-ray system with
following limitations of use: The device may
be used for handheld diagnostic imaging of
body extremities The device may be used for
stand mounted diagnostic imaging of head,
abdomen, or extremities. The device may
be used for stand mounted imaging of the
chest when used without a grid. - Not to be
used on bariatric patients, unless imaging
body extremities. – Not for mammography
use. - The TR90BH is not intended to replace
a stationary radiographic system, which may
be required for full optimization of image
quality and radiation exposure for different
exam types | The iQFlex Pro Mobile X-ray System is a medical
device intended for use by a qualified/trained
physician or technician for handheld diagnostic
imaging of body extremities The device may be
used for stand mounted diagnostic imaging of
head, abdomen, or extremities. The device
may be used for stand mounted imaging of the
chest. - Not to be used on bariatric patients,
unless imaging body extremities. Not for
mammography use. Not intended to replace a
stationary radiographic system, which may be
required for full optimization of image quality
and radiation exposure for different exam
types.
SAME INDICATIONS |
| Weight | 7.5 kg | 5.4 kg (11.9 lbs) LIGHTER |
| Size | 219 x 442 x 190 (mm) | 274 x 227 x 186 (mm) SMALLER SIZE |
| Energy
Source | Lithium-Ion Rechargeable Battery,
57.6VDC | Lithium-Ion Rechargeable Battery,
14.4Vdc/6700mAh(4S2P) |
| Output | 20mA @ 40 ~ 60kVDC
(2kVp steps) 15mA @ 62 ~
80kVDC (2kVp steps) 10mA
@ 82 ~ 90kVDC (2kVp
steps) High Power Mode
15mA @ 82 ~ 90kVDC (2kVp steps) | 50kVp ~ 80kVp, 20mA, 0.4mAs ~ 3.2mAs
50kVp ~ 80kVp, 15mA, 4mAs ~ 40mAs
81kVp ~ 90kVp, 16mA, 0.4mAs ~ 3.2mAs
81kVp ~ 90kVp, 10mA, 4mAs ~ 32mAs
91kVp ~ 100kVp, 16mA, 0.4mAs ~ 3.2mAs
91kVp ~ 100kVp, 10mA, 4mAs ~ 16mAs
SLIGHTLY HIGHER CAPABILITY |
| Item | Predicate Device MinXray TR90BH
(K182207) | Subject Device iQFlex Pro (without digital
imaging) |
| User
Interface | Up-Down pushbuttons for kVp
selections and exposure time
selections with LED indicators
mAs indicator | Up/Down pushbuttons for kV/exposure
time(mAs) selections and LED indicators
for selected
kVp/exposure time(mAs)
SIMILAR |
| Exposure
time | 0.011.00sec, 0.01sec step0.3sec, 0.01sec step | 0.02
High Power Mode
0.014.00sec: 0.02, 0.03, 0.04, 0.05, 0.06,90kV | 50~100kV SLIGHTLY HIGHER |
0.08, 0.10, 0.13, 0.16, 0.20, 0.40, 0.50, 0.63,
0.80, 1.0,1.30, 1.60, 2.00, 2.50, 3.20, 4.00sec
(21 steps) SIMILAR |
| Memory
Settings | 10 memories | 5 memories |
| HF
Generator | High Frequency | High Frequency SAME |
| kW | 1.35kW | 1.6kW SLIGHTLY HIGHER |
| kV | 40
| X-ray Tube | Canon D-0814, 0.8mm, 16degree, kJ | CEI OX/100, 1.0mm, 16degree, 14kJ |
| Collimator | Mikasa BLD34L | FSI Manual Type, Double Slit |
| Photo | Image: Yellow portable x-ray machine | Image: Front view of portable x-ray machine
Image: Back view of portable x-ray machine |
Table 1. Comparison of Technology Characteristics
5
7) Performance Testing:
The iQFlex Pro was tested to and conforms to the following standards:
US FDA Radiation Safety Performance Standard, Sec. 21CFR1020.30 Diagnostic x-ray systems and their major components
IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Note: This standard is recognized
6
with relevant US national differences applied FDA RECOGNITION NUMBER 19-49 IEC 60601-1-2:2014/A1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements FDA RECOGNITION NUMBER 19-36
IEC 60601-1-3 Edition 2.1 2013-04 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment FDA RECOGNITION 12-269
IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013, IEC 60601-1-6:2010/AMD2:2020, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance -Collateral standard: Usability FDA #5-132
60601-2-54 Edition 1.2 2018-06 CONSOLIDATED VERSION Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy FDA RECOGNITION 12-317
Consulted Guidance: IEC TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems FDA RECOGNITION 19-19
Discussion of Testing
The performance characteristics and operation / usability of the iQFlex Pro were evaluated in nonclinical (bench) testing. These studies have demonstrated the intended workflow, related performance, overall function, shipping performance, verification and validation of requirements for intended use, and reliability of the system including both software requirements. Non-clinical test results have demonstrated that the device conforms to its specifications. Predefined acceptance criteria were met and test results have demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device. The following performance data were provided in support of the substantial equivalence determination:
- . Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted on the iQFlex Pro Mobile X-ray System in compliance to IEC 60601-1:2005/AMD1:2012 and IEC 60601-1-2:2014 – Medical electrical equipment Part 1-2, Electromagnetic Compatibility. EMC Testing was performed for both Class B environments.
- . Software Verification and Validation Testing
Software verification and validation testing was conducted and documentation Has been provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device is considered to present a "moderate" level of concern. This is based on the fact that a malfunction of or latent design flaw in the software component could lead to an erroneous diagnosis, or to a delay in delivery of appropriate medical care that may lead to a minor injury.
· Management of Cybersecurity
There is a USB-C port on the device, but it is used only for battery charging, so no Internet connection possible. This is not a cybersecurity device even though it has firmware and a USB-C port.
· Image Quality Evaluation
Test images of the head, chest, abdomen, and extremities in order to assure that diagnostic quality imaging can be obtained using this generator. The images were evaluated by a Board
7
Certified Radiologist and were found to be of excellent diagnostic quality.
- Clinical Studies: A limited clinical test was performed to demonstrate that the device could image 8) anatomy other than extremities. A Board Certified Radiologist performed a successful review.
- CONCLUSION: After analyzing bench and clinical image tests, it is the conclusion of First Source 9) Inc. that the iQFlex Pro Mobile X-ray System is as safe and effective as the predicate device, has the same indications for use, has few technological differences, which are addressed through performance testing and compliance with the standards listed above, thus rendering it substantially equivalent to the predicate device.