(63 days)
No
The summary does not mention AI, ML, or related terms, and the device description focuses on hardware components and previously cleared software.
No
The device is used for taking diagnostic radiographic exposures, which is for diagnosis, not therapy.
Yes
The device is described as taking "diagnostic radiographic exposures," indicating its role in the diagnostic process.
No
The device description explicitly states it is comprised of a High Voltage Generator and a digital flat panel image receptor, which are hardware components.
Based on the provided information, 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 description clearly states that this device is a mobile X-ray system used for taking diagnostic radiographic exposures of various body parts. This is an in vivo imaging technique, meaning it is performed on a living organism (the patient) directly, not on a sample taken from the patient.
- Intended Use: The intended use describes taking images of the skull, spinal column, extremities, and other body parts, which are all in vivo applications.
- Device Components: The components listed (High Voltage Generator, digital flat panel image receptor, Operator Console) are all typical of an X-ray imaging system, not an IVD device.
Therefore, the function and intended use of this device fall under the category of medical imaging, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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, 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.
Product codes (comma separated list FDA assigned to the subject device)
IZL, MOB
Device Description
The MX40 is comprised of a High Voltage Generator with a maximum power output of 50 kW, the MX40 can meet different exposure needs for varying positions and body mass. With the MX40's state-of-the-art design and powerful 50 kW generator coupled with the Varex PaxScan digital flat panel image receptor and E-COM Digital Radiography Operator Console (used on previously cleared devices K130883 and K143232), users can obtain clearer images quickly and easily. Our latest mobile X-ray system is based on the revolutionary MX family.
Advanced technology with superior design
- High frequency generator for power exposure
- Compact body and better usability
X-ray Technicians and healthcare service providers can acquire sharp images with the MX40's 50KW (630 mA) imaging power. The MX40's new power supply unit not only supports operation by battery, but also 220V/110V AC. The new lithium battery has a longer endurance time, shorter charge time, and longer useful life. MX40 should only be used by certified and/or trained professionals.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
skull, spinal column, extremities, and other body parts.
Indicated Patient Age Range
adult and pediatric subjects
Intended User / Care Setting
qualified/trained doctor or technician / Medical Facilities and/or Universities
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing, Performance Testing (non-clinical tests), International Standards Testing, by the use of the DIGITAL IMAGE PANEL previously cleared (as part of K161459) and IMAGE ACQUISITION SOFTWARE previously cleared (as part of K130883 & K143232).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1720 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 contains two logos. The first logo is the Department of Health & Human Services - USA logo, which features a stylized human figure. The second logo is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name of the administration in blue text to the right of the square.
September 14, 2018
Huestis Machine Corporation Frederick Correira General Manager 68 Buttonwood Street Bristol, Rhode Island 02809
Re: K181874
Trade/Device Name: MX40 Mobile Digital X-ray System Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL, MOB Dated: August 9, 2018 Received: August 15, 2018
Dear Frederick Correira:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone
(1-800-638-2041 or 301-796-7100).
Sincerely.
Hol 2. Nils
Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K181874
Device Name MX40 Mobile Digital X-Ray System
Indications for Use (Describe)
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, 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.
| 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
HUESTIS MACHINE CORPORATION
68 Buttonwood Street, Bristol, Rhode Island 02809 USA |Phone: 401-253-5500 |Fax: 401-253-7350 www.huestis.com
510(K) SUMMARY
Date Prepared: April 26th 2018
This 510(K) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92
1. General Information
HUESTIS MACHINE CORP.
68 Buttonwood Street, Bristol, Rhode Island 02809 USA Phone: 401-253-5500 Fax: 401-253-7350 Establishment registration number: 1219183
2. Contact Person:
Frederick M. Correira General Manager 68 Buttonwood Street Bristol, RI 02809 Phone (401) 253-5500 X-144 Fax (401) 253-5542 Email: fredc@huestis.com
3. Device Name and Classification
| Trade Name: | MX40 Mobile Digital X-Ray System |
|---|---|
| Classification Name: | Mobile X-Ray System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR 892.1720 |
| Device Classification: | Class II |
| Primary Product Code: | IZL |
| Secondary Product Code: | MQB |
4. Legally Marketed Predicate Device
| Trade Name: | RadPro Mobile 40KW |
|---|---|
| 510(k) Clearance Number: | K161345 |
| Clearance Date: | 07/06/2016 |
| Classification Name: | Mobile X-Ray System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR 892.1720 |
| Device Classification: | Class II |
| Primary Product Code: | IZL |
| Secondary Product Code | MQB |
4
5. Device description
The MX40 is comprised of a High Voltage Generator with a maximum power output of 50 kW, the MX40 can meet different exposure needs for varying positions and body mass. With the MX40's state-of-the-art design and powerful 50 kW generator coupled with the Varex PaxScan digital flat panel image receptor and E-COM Digital Radiography Operator Console (used on previously cleared devices K130883 and K143232), users can obtain clearer images quickly and easily. Our latest mobile X-ray system is based on the revolutionary MX family.
Advanced technology with superior design
- High frequency generator for power exposure
- Compact body and better usability
X-ray Technicians and healthcare service providers can acquire sharp images with the MX40's 50KW (630 mA) imaging power. The MX40's new power supply unit not only supports operation by battery, but also 220V/110V AC. The new lithium battery has a longer endurance time, shorter charge time, and longer useful life. MX40 should only be used by certified and/or trained professionals.
6. Indications for Use
Intended for use by a qualified/trained doctor or technician on both 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.
5
-
- Substantial Equivalence: The MX40 Mobile Digital X-Ray system is substantially equivalent to the commercially available RadPRO Mobile 40KW Digital X-Ray system with identical indications for use.
| Summary of Technological & Functional Characteristics & Comparison to Predicate. | ||
|---|---|---|
| The following table provides a comparison the MX40 Mobile Digital X-Ray System to the Predicate Device identified | ||
| to demonstrate substantial equivalence. | ||
| Proposed Device | Predicate Device | |
| Model Name | MX40 -Mobile Digital X-ray | |
| System | RadPRO Mobile 40KW | |
| (K161345) | ||
| Intended Use | 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. | 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. | ||
| General Information | ||
| Modes of Operation | Manual | Manual |
| Classification Name | Mobile X-Ray System | Mobile X-Ray System |
| Classification Panel | Radiology | Radiology |
| Classification Regulation | 21 CFR 892.§1720 | 21 CFR 892.§1720 |
| Product Code | IZL | IZL |
| Subsequent Product Code | MQB | MQB |
| Medical Device Class | Class II | Class II |
| Performance Standard | 21CFR1020.30 | 21CFR1020.30 |
| Configuration | Mobile Battery or Line | |
| Operated | Mobile Battery or Line | |
| Operated | ||
| Power Source | Single Phase Line Regulation from | |
| 100 - 240 Vac (+/-10%) | Single Phase Line Regulation from | |
| 100 - 240 Vac (+/-10%) | ||
| Electrical Safety and EMC | IEC 60601-1 and IEC 60601- | |
| 1-2 | IEC 60601-1 and IEC 60601-1-2 | |
| Standards (Other than Electrical and EMC) | Wi-Fi 802.11b/g and: FCC | |
| Rules and Regulations | Wi-Fi 802.11b/g and: FCC Rules and | |
| Regulations | ||
| Generator | ||
| Type | Shenzhen Browiner | Sedecal |
| Generator Power Level | 50KW | 40 KW |
| kV Range | 40 - 150KV | 40 - 150KV |
| mA Range | 10 - 630 mA | 10 - 500 mA |
| Exposure Time Range | 0.001 – 6.3 sec | 0.001 - 10 sec |
| mAs Range | 0.1 – 320 mAs | 0.1 - 500 mAs |
| X-Ray Tube | ||
| Type | Toshiba E7843X | |
| Material | Rhenium-Tungsten Molybdenum | |
| Max Voltage | 150 kVp | 150kVp |
| Nominal Focal Spot | 0.6/1.2 | 0.6/1.2 |
| Anode type | Rotating | Rotating |
| Nominal Anode Input Power | Large Focus 50kW @ 6Hz | |
| Small focus 22kW @ 60Hz | ||
| Imaging Panel | ||
| Image acquisition panels (Both systems | ||
| use already cleared digital panels) | Varian 4336R | |
| PAXSCAN 4336W | ||
| Pixel Size 144 μm/3072 x | ||
| 2560 pixels | ||
| (previously cleared as part of | ||
| K161459, 09/06/2016) | Canon CXDI 401C Wireless (CSI) | |
| K133693 | ||
| Pixel size: 125 μm3320 x 3408 pixels | ||
| Canon CXDI 701C Wireless (CSI) | ||
| K131106 | ||
| Pixel size: 125 μm 2800 x 3408 pixels | ||
| Canon CXDI 801C Wireless (CSI) | ||
| K131106 | ||
| Pixel size: 125 μm 2800 x 2192 pixels | ||
| System Software | ||
| Image acquisition and control Software | ECOM Digital Radiography | |
| Operator Console (Acquisition | ||
| Software and | ||
| Graphical Interface-previously | ||
| cleared as part of K130883 | ||
| (04/18/13) and K143232 (01/30/15) | Canon control software CXDI- NE | |
| Operating System | Windows OS | Windows OS |
| Environment of use | Medical Facilities and/or | |
| Universities | Medical Facilities and/or | |
| Universities | ||
| Collimator | ||
| Model | Shenzhen Browiner Tech Co., | |
| Ltd Or Huestis 150MC | Ralco R221 DHHS Manual | |
| Collimator | ||
| Operation | Manual, square/rectangular | |
| field, field indicator lamp | ||
| Anatomical Programs | 500+ Anatomical settings | 500+ Anatomical settings |
| External Connectivity | ||
| Connection | Wi-Fi and Ethernet Cable | Wi-Fi and Ethernet Cable |
| DICOM | YES | YES |
| Wi-Fi Communication with detectors | Wireless | Wireless |
6
7
8. Summary of non-clinical performance testing and data:
The MX40 Mobile Digital X-Ray device complies with and/or was tested in accordance with the following FDA and International Standards:
- ISO14971 Application of risk management to medical devices
- IEC60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- . IEC60601-1-2 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests.
- . EN 55032:2015 Electromagnetic compatibility of multimedia equipment – Emission requirements
- EN 55024:2010 +A1:2015 Information technology equipment — Immunity characteristics — Limits and methods of measurement
- . IEC60601-1-3 Medical electrical equipment Part 1-3: General requirements for basic safety and essential performance – Collateral standard: Radiation protection in diagnostic X-Ray equipment
- . EN60601-1-6:2010 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance – collateral standard: Usability
- . IEC60601-2-54 Medical electrical equipment Part 2-54: Particular requirements for the basic safety and essential performance of X-Ray equipment for radiography and radioscopy
- IEC62304 Medical device software – Software life-cycle processes
- ISO13485 Quality management for medical devices
- 21CFR 1020.30 Diagnostic X-Ray systems and their major components
- 21CFR 1020.31 Radiographic equipment
9. Conclusion
Bench Testing, Performance Testing (non-clinical tests), International Standards Testing, by the use of the DIGITAL IMAGE PANEL previously cleared (as part of K161459) and IMAGE ACQUISITION SOFTWARE previously cleared (as part of K130883 & K143232). There are no new indications for use, therefore, Huestis Machine Corporation concludes the new medical device MX40-Mobile Digital X-ray System is as safe and effective as the predicate medical device sited and it substantially equivalent to the predicate medical device.
8
Image /page/8/Figure/0 description: This image shows the MX40 Mobile Digital X-Ray System. The system includes an X-Ray tube, collimator, handlebar, back panel, and accessory box. It also features a telescopic arm, column, capacitive screen, 50 kW x-ray generator (40-150 kVp), anti-collision system, ultrasonic anti-collision, column slots, front wheel, and emergency-ready switch.
9
Image /page/9/Figure/0 description: This image shows a RadPRO Mobile 40KW - Predicate Device (K161345). The device has an X-Ray Tube, Collimator, Handle Bar, Back Panel, and Accessory Box. It also has a Telescopic Arm, Capacitive Screen, 40 kW x-ray generator (40-150 kVp), Anti-collision system, Ultrasonic Anti-collision, Column slots, Emergency-ready switch, Front Wheel, and Driving Wheel.