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.

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.

AI/ML Overview

The provided text describes the MX40 Mobile Digital X-ray System and its substantial equivalence to a predicate device, the RadPRO Mobile 40KW. However, it does not contain information about acceptance criteria for device performance in terms of diagnostic accuracy or a clinical study proving the device meets specific acceptance criteria related to its diagnostic output.

Instead, the document focuses on:

Regulatory Clearance: A 510(k) premarket notification for demonstrating substantial equivalence to a legally marketed predicate device.
Device Description: Details about the MX40's components and features.
Comparison to Predicate Device: A table detailing the technological and functional characteristics of the MX40 compared to the RadPRO Mobile 40KW.
Non-Clinical Performance Testing: A list of international and FDA standards with which the device complies.
Conclusion: The device is considered substantially equivalent to the predicate based on non-clinical tests and the use of previously cleared digital image panels and acquisition software.

Therefore, many of the requested details about acceptance criteria for diagnostic performance and a clinical study are not available in the provided text.

Here's a summary of what can be extracted:

Acceptance Criteria and Device Performance (based on regulatory substantial equivalence)

The acceptance criteria are implied by demonstrating substantial equivalence to the predicate device, the RadPRO Mobile 40KW (K161345). The device is deemed to meet these criteria by complying with relevant medical device standards and having comparable technical specifications.

Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	Reported Device Performance (MX40)
Intended Use: Diagnostic radiographic exposures of skull, spinal column, chest, abdomen, extremities, and other body parts for adult and pediatric subjects, performed with patient sitting, standing, or lying prone/supine. Not for mammography.	Matches predicate device's intended use exactly.
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 Standards: IEC 60601-1 and IEC 60601-1-2	IEC 60601-1 and IEC 60601-1-2
Other Standards: Wi-Fi 802.11b/g and FCC Rules and Regulations	Wi-Fi 802.11b/g and FCC Rules and Regulations
kV Range: 40 - 150kV	40 - 150KV
Nominal Focal Spot: 0.6/1.2	0.6/1.2
Anode type: Rotating	Rotating
System Software: Previously cleared image acquisition and control software (K130883, K143232)	ECOM Digital Radiography Operator Console (Acquisition Software and Graphical Interface-previously cleared as part of K130883 and K143232)
Operating System: Windows OS	Windows OS
Environment of Use: Medical Facilities and/or Universities	Medical Facilities and/or Universities
Collimator Operation: Manual, square/rectangular field, field indicator lamp	Manual, square/rectangular field, field indicator lamp
Anatomical Programs: 500+ Anatomical settings	500+ Anatomical settings
External Connectivity: Wi-Fi and Ethernet Cable	Wi-Fi and Ethernet Cable
DICOM: YES	YES
Wi-Fi Communication with detectors: Wireless	Wireless

Deviations/Improvements over Predicate:

Generator Power Level: MX40: 50KW vs. Predicate: 40 KW
mA Range: MX40: 10 - 630 mA vs. Predicate: 10 - 500 mA
Exposure Time Range: MX40: 0.001 – 6.3 sec vs. Predicate: 0.001 - 10 sec
mAs Range: MX40: 0.1 – 320 mAs vs. Predicate: 0.1 - 500 mAs
X-Ray Tube: MX40: Toshiba E7843X vs. Predicate: (not specified, but implies a difference)
Nominal Anode Input Power: MX40: Large Focus 50kW @ 6Hz, Small focus 22kW @ 60Hz vs. Predicate: (not specified)
Imaging Panel: MX40 uses Varian 4336R, PAXSCAN 4336W (previously cleared K161459) vs. Predicate using Canon CXDI series (K133693, K131106). Both are previously cleared digital panels.
Generator Type: MX40: Shenzhen Browiner vs. Predicate: Sedecal
Collimator Model: MX40: Shenzhen Browiner Tech Co., Ltd Or Huestis 150MC vs. Predicate: Ralco R221 DHHS Manual Collimator

Regarding a study to prove the device meets acceptance criteria:

Sample size used for the test set and the data provenance: Not applicable. The submission is a 510(k) for substantial equivalence based on non-clinical performance and a comparison of technical specifications, not a clinical study on diagnostic performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established from expert readings for a diagnostic performance study.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication was used for diagnostic performance.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an X-ray system, not an AI-powered diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an X-ray system, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this 510(k) clearance is the demonstrated compliance with engineering standards and performance characteristics of the device itself and its components, and its substantial equivalence to a predicate device.
The sample size for the training set: Not applicable. This device is an X-ray system, not a machine learning algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary of Non-Clinical Performance Testing:
The device undergone non-clinical performance testing for compliance with various international and FDA standards, including:

ISO14971 (Risk Management)
IEC60601-1 (Basic Safety and Essential Performance)
IEC60601-1-2 (Electromagnetic Compatibility)
EN 55032, EN 55024 (Electromagnetic Compatibility)
IEC60601-1-3 (Radiation Protection)
EN60601-1-6 (Usability)
IEC60601-2-54 (X-Ray Equipment Specific Requirements)
IEC62304 (Software Life-cycle Processes)
ISO13485 (Quality Management)
21CFR 1020.30 (Diagnostic X-Ray systems and their major components)
21CFR 1020.31 (Radiographic equipment)

The submission leverages previous clearances for the digital image panel (K161459) and the image acquisition software (K130883 and K143232) to support the substantial equivalence claim.

Summary

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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

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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

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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)

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."

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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

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5. Device description

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.

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1. 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 identifiedto demonstrate substantial equivalence.
	Proposed Device	Predicate Device
Model Name	MX40 -Mobile Digital X-raySystem	RadPRO Mobile 40KW(K161345)
Intended Use	Intended for use by aqualified/trained doctor ortechnician on both adult andpediatric subjects for takingdiagnostic radiographic exposuresof the skull, spinal column, chest,abdomen, extremities, and otherbody parts. Applications can beperformed with the patientsitting, standing, or lying in theprone or supine position. Not formammography.	Intended for use by aqualified/trained doctor or technicianon both adult and pediatric subjectsfor taking diagnostic radiographicexposures of the skull, spinal column,chest, abdomen, extremities, andother body parts. Applications can beperformed with the patient sitting,standing, or lying in the prone orsupine position. Not formammography.
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 LineOperated	Mobile Battery or LineOperated
Power Source	Single Phase Line Regulation from100 - 240 Vac (+/-10%)	Single Phase Line Regulation from100 - 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: FCCRules and Regulations	Wi-Fi 802.11b/g and: FCC Rules andRegulations
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 @ 6HzSmall focus 22kW @ 60Hz
Imaging Panel
Image acquisition panels (Both systemsuse already cleared digital panels)	Varian 4336RPAXSCAN 4336WPixel Size 144 μm/3072 x2560 pixels(previously cleared as part ofK161459, 09/06/2016)	Canon CXDI 401C Wireless (CSI)K133693Pixel size: 125 μm3320 x 3408 pixelsCanon CXDI 701C Wireless (CSI)K131106Pixel size: 125 μm 2800 x 3408 pixelsCanon CXDI 801C Wireless (CSI)K131106Pixel size: 125 μm 2800 x 2192 pixels
System Software
Image acquisition and control Software	ECOM Digital RadiographyOperator Console (AcquisitionSoftware andGraphical Interface-previouslycleared 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/orUniversities	Medical Facilities and/orUniversities
Collimator
Model	Shenzhen Browiner Tech Co.,Ltd Or Huestis 150MC	Ralco R221 DHHS ManualCollimator
Operation	Manual, square/rectangularfield, 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

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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.

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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.

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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.

Regulation Number and Section

§ 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.