The ARIX RAD system is a radiographic system used for producing X-ray images of the human body, including all anatomical regions such as the head, thorax, column, abdomen, extremities and internal organs. The system is design to be used with conventional film or CR systems and can be interfaced with a digital detector, but neither the X-Ray detector nor the image acquisition system are part of the ARIX RAD radiographic system. The acquisition system comes as a separate system.

The ARiX RAD system is not intended for use in mammography, fluoroscopy or angiography.

The ARiX RAD system is intended for adults and pediatric patients. The pediation is as follows:

· Child (3-12 yrs.), approximately 12 kg (26 lb.) to 51 kg (114 lb.)
· Adolescent (12-21 yrs.), approximately 51 kg (114 lb.) to 80 kg (176 lb.)

Device Description

The ARiX RAD Radiographic System designed and manufactured by Compañía Mexicana de Radiología (CMR) is a general purpose, computed radiography (CR) X-ray system used for diagnostic imaging (analog radiology) of adults and pediatric patients for taking 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. The device is designed to meet the requirements of basic radiology procedures.

The ARIX RAD Radiographic system is capable of interfacing with AeroDR, PaxScan 4336W, Venu1717 detector in trigger mode. However, it is also capable of operating with external triggering devices providing the Hand-switch activation signals and the X-Ray Enable signal of the digital system as an external authorization for the X-Ray emission.

AI/ML Overview

The provided text describes the ARiX RAD Radiographic System and its substantial equivalence to a predicate device (Sedecal Millennium Plus). It outlines technical specifications and conformity to various standards but does not contain information on acceptance criteria for a device's performance based on diagnostic accuracy, sensitivity, or specificity, nor does it present a study proving the device meets such criteria.

The document focuses on demonstrating that the ARiX RAD Radiographic System is substantially equivalent to a legally marketed predicate device (Sedecal Millennium Plus) through comparisons of intended use, technological characteristics, and conformance to recognized safety and performance standards for X-ray systems. It explicitly states that clinical investigations were not required as the indications for use are equivalent to the predicate device, which has a proven safety and effectiveness record.

Therefore, many of the requested items (acceptance criteria, reported device performance figures, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and effect sizes) are not available in the provided text, as the regulatory submission did not mandate such studies for this type of device and its specific pathway to market.

Below, I will extract and summarize the information that is available in the provided text, and explicitly note when requested information is absent.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on compliance with harmonized standards for X-ray equipment, electrical safety, EMC, and radiation safety. The "reported device performance" refers to the device successfully passing the required tests for these standards. There are no diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) provided as this was not a clinical performance study.

Acceptance Criteria (Compliance with Standards/Regulations)	Reported Device Performance
IEC 60601-1 (+ ES60601-1) - General Requirements for Basic Safety and Essential Performance	Passed required testing
IEC 60601-1-2 - Electromagnetic Compatibility	Passed required testing
IEC 60601-1-3 - General Requirements for Radiation	Passed required testing
IEC 60601-1-6 - Usability	Passed required testing
IEC 60601-2-54 - X-ray Equipment for Radiography and Radioscopy	Passed required testing
ISO 10993-1, -5, -10 - Biological Evaluation of Medical Devices (Cytotoxicity, Irritation, Sensitization)	Passed required testing
ISO 14971 - Risk Analysis (FMEA)	Complied
21 CFR Part 1020.30 and 21 CFR Part 1020.31 (Performance Standards for X-Ray Systems)	Complied
FDA Guidance Documents (e.g., Software, Solid State X-ray Imaging, Pediatric Information, Cybersecurity)	Complied

2. Sample size used for the test set and the data provenance

Sample size for test set: Not applicable (N/A). The document describes non-clinical performance data (testing against various standards) rather than clinical testing with a "test set" of patients or data. The testing involved a final finished device unit.
Data provenance: N/A. The testing was non-clinical, performed on the device itself for compliance with engineering and safety standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of experts: N/A. This information is not relevant to the non-clinical testing performed.
Qualifications of experts: N/A.

4. Adjudication method for the test set

Adjudication method: N/A. Not a clinical study requiring ground truth adjudication.

5. 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

MRMC study done: No.
Effect size: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone study done: No. This device is an X-ray radiographic system, not an AI algorithm.

7. The type of ground truth used

Type of ground truth: N/A. The "ground truth" for the non-clinical tests was successful adherence to the quantitative and qualitative requirements of the listed international and national standards (e.g., electrical safety, radiation output, EMC, usability, biocompatibility).

8. The sample size for the training set

Sample size for training set: N/A. This is not an AI/machine learning device. The document describes a traditional medical device (radiographic system) for which no "training set" in the machine learning sense would be used. The device's design, development, and manufacturing stages included internal quality assurance and quality control measures.

9. How the ground truth for the training set was established

Ground truth for training set: N/A.

Summary

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November 26, 2018

Compania Mexicana De Radiologia CGR, S.A. DE C.V. % Stuart Goldman Senior Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Bldg. 1, Suite 300 AUSTIN, TEXAS 78746

Re: K182134

Trade/Device Name: ARiX RAD Radiographic System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: KPR Dated: October 11, 2018 Received: October 17, 2018

Dear Stuart Goldman:

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.

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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 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.

Hole 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

510(k) Number (if known) K182134

Device Name ARiX RAD Radiographic System

Indications for Use (Describe)

The ARiX RAD system is not intended for use in mammography, fluoroscopy or angiography.

The ARiX RAD system is intended for adults and pediatric patients. The pediation is as follows:

· Child (3-12 yrs.), approximately 12 kg (26 lb.) to 51 kg (114 lb.)
· Adolescent (12-21 yrs.), approximately 51 kg (114 lb.) to 80 kg (176 lb.)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary ARiX RAD Radiographic System K182134

5.1 Submission Sponsor

Compañía Mexicana de Radiología CGR SA de CV Fraccionamiento Industrial la Noria s/n El Marqués, Querétaro C.P. 76240 México (55) 54821300

Tonatiuh Monroy Soberón Contact: Title: Design Engineer, Regulatory Specialist

5.2 Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327-9997

Contact: Stuart R. Goldman Title: Sr. Consultant RA/QA Email: Stuart.Goldman@UL.com

5.3 Date Prepared

October 1, 2018

5.4 Device Identification

Trade Name:	ARIX RAD Radiographic System
Common Name:	Radiographic System
Classification Name:	Stationary X-ray
System Regulation Number:892.1680
Product Code:	KPR, System, X-Ray, Stationary
Class:	Class 2
Classification Panel:	Radiology

5.5 Legally Marketed Predicate Device

Sedecal Millennium Plus (K090279); Manufacturer: Sedecal S.A.

5.6 Indication for Use

The ARiX RAD system is a radiographic system used for producing X-ray images of the human body, including all anatomical regions such as the head, thorax, column, abdomen, extremities and internal organs. The system is designed to be used with conventional film or CR systems and can be interfaced

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with a digital detector, but neither the X-Ray detector nor the image acquisition system are part of the ARiX RAD radiographic system. The acquisition system comes as a separate system.

The ARiX RAD system is not intended for use in mammography, fluoroscopy or angiography.

The ARiX RAD system is intended for adults and pediatric patients. The pediatric population is as follows:

. Child (3-12 yrs.), approximately 12 kg (26 lb.) to 51 kg (114 lb.)
. Adolescent (12-21 yrs.), approximately 51 kg (114 lb.) to 80 kg (176 lb.)

5.7 Device Description

5.8 Substantial Equivalence Discussion

CMR has selected the Sedecal Millennium Plus X-ray system previously cleared by Sedecal S.A. under K090279 as the predicate device for their 510(k) submission. Table 5-1 compares the ARIX RAD Radiographic System to the predicate device with respect to indications for use, principles of operation, technological characteristics, components/materials, and performance testing. The comparison of the subject device to the predicate device provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.

Attribute	Subject Device	Predicate Device	Comparison
Manufacturer	Compañía Mexicana deRadiología (CMR)	Sedecal S.A.	na
Device Name	ARIX RAD RadiographicSystem	Sedecal Millennium Plus	na
510(k) #	Pending	K090279	na
Product Code	KPR	KPR	Same
Regulation Number	892.1680	892.1680	Same
Class	II	II	Same
Review Panel	Radiology	Radiology	Same
Attribute	Subject Device	Predicate Device	Comparison
Indications for Use	The ARIX RAD system is aradiographic system used forproducing X-ray images of thehuman body, including allanatomical regions such asthe head, thorax, column,abdomen, extremities andinternal organs. The system isdesigned to be used withconventional film or CRsystems and can be interfacedwith a digital detector, butneither the X-Ray detector northe image acquisition systemare part of the ARIX RADradiographic system. Theacquisition system comes as aseparate system.The ARIX RAD system is notintended for use inmammography, fluoroscopyor angiography.The ARIX RAD system isintended for adults andpediatric patients. Thepediatric population is asfollow:Child (3-12 yrs.),approximately 12kg (26 lb.) to51kg (114 lb.)Adolescent (12-21yrs.), approximately 51kg (114lb.) to 80kg (176lb.)	These Digital RadiographicSystems are intended foruse by a qualified/traineddoctor or technician onboth adult and pediatricsubjects for takingdiagnostic radiographicexposures of the skull,spinal column, chest,abdomen, extremities, andother body parts.Applications can beperformed with the patientsitting, standing, or lying inthe prone or supineposition.	Similar. Both the subjectand predicate devicehave the same intendeduse as general-purposediagnostic radiographicsystems used forproducing X-ray imagesof the human body,including all anatomicalregions such as thehead, thorax, column,abdomen, extremitiesand internal organs, andare indicated for use onadult, adolescent, andpediatric patients.
TechnologyOverview	General diagnostic X-raysystem consisting of a tube-head and collimator assembly,with a generator, generatorcontrol, and an X-ray table.	General diagnostic X-raysystem consisting of a tube-head and collimatorassembly, with a generator,generator control, and an X-ray table.	Same. Both the subjectand predicate device area general typeradiographic systemused for producingdiagnostic X-ray imagesof the human body, areof similar design andconsist of essentially thesame types ofsubcomponents andoperate using the same
Attribute	Subject Device	Predicate Device	Comparison
Mechanism ofAction	X-ray tube(Dual Focal Spot)	X-ray tube(Dual Focal Spot)	Same
Configuration	Column mount	Column mount	Same
Positioning Controls	Enhanced	Enhanced	Same
Collimator	Manual(made by Ralco)	Manual(made by Ralco)	Same
AnatomicalLocation	Full body	Full body	Same
Power Supply	220 VCA	220 VCA	Same
Generator	High frequency: 32, 50, 60 and80 kW (made by CMR)	High frequency: 50 - 80 kW(made by Sedecal)	Similar. The minordifference between thesmaller generator sizeoffered by CMR (32 kW)does not raise any newquestions of safety andeffectiveness betweenthe subject andpredicate device, as thesubject device hassuccessfully passedelectrical safety testingper 60601-1.
Exposure VoltageRanges forAvailableGenerators	40 - 125 kVp or 40 - 150 kV	40 - 125 kV or 40 - 150 kV	Same
X-ray Current forAvailableGenerators	400 - 800 mA	100 - 300 mA	Similar. The differencesin the X-ray currentproduced by thegenerators made byCMR do not raise anynew questions of safetyand effectivenessbetween the subject andpredicate device, as thesubject device hassuccessfully passedelectrical safety testingper IEC 60601-1, and IEC60601-2-54.
X-ray ExposureTimes	0.001 - 10 s	0.001 - 10 s	Same
Attribute	Subject Device	Predicate Device	Comparison
Controlled
Design andPerformance	21 CFR 1020.3021 CFR 1020.31	21 CFR 1020.30	Same
Electrical Safetyand EMC	IEC 60601-1IEC 60601-1-2IEC 60601-2-54(passed TUV)	IEC 60601-1(passed)	Same

Table 5-1 – Comparison of Device Characteristics

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5.9 Non-Clinical Performance Data

As part of demonstrating substantial equivalence of the ARiX RAD Radiographic System to the predicate device, CMR submitted a final finished device for extensive testing to the following voluntary standards:

. IEC 60601-1 (+ ES60601-1), Medical electrical equipment - Part 1: General Requirements for Basic Safety and Essential Performance (passed required testing)
. IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility - Requirements and Tests (passed required testing)
IEC 60601-1-3, Medical Electrical Equipment Part. 1: General Requirements for Safety 3. Collateral ● Standard: General Requirements for Radiation (passed required testing)
. IEC 60601-1-6, Medical electrical equipment - Part 1-6: General Requirements for Safety - Collateral Standard: Usability (passed required testing)
. IEC 60601-2-54, Medical Electrical Equipment - Part 2-54: Particular Requirements for the Basic Safety and Essential Performance of X-ray Equipment for Radiography and Radioscopy (passed required testing)
ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process
- ISO 10993-5 (cytotoxicity) (passed required testing) O
- ISO 10993-10 (irritation) (passed required testing) O
- ISO 10993-10 (sensitization) (passed required testing) O

Additionally, CMR also performed the following internal quality assurance and quality control measures during the design, development and manufacturing stages of their ARiX RAD Radiographic System:

Risk Analysis (FMEA) per ISO 14971, Medical Devices - Application of Risk Management to Medical Devices
Compliance to 21 CFR Part 1020.30 and 21 CFR Part 1020.31.
Compliance to the following FDA guidance documents:
- o Medical Devices and Radiation-Emitting Products, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices o Pediatric Information for X-ray Imaging Device Premarket Notifications
- Content of Premarket Submissions for Management of Cybersecurity in o Medical Devices

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5.10 Clinical Performance Data

Clinical investigations were not required to support the ARiX RAD Radiographic System, as the indications for use are equivalent to those of the predicate device. These types of devices, including the predicate device, have been on the market for many years with proven safety and effectiveness. The non-clinical testing detailed in this submission supports the substantial equivalence of the subject device.

Statement of Substantial Equivalence 5.11

The ARIX RAD Radiographic System has the same intended use as the predicate device. The comparison of technological characteristics, non-clinical performance data, safety testing, biocompatibility testing, and software validation demonstrates that the subject device is as safe and effective as the predicate device. Therefore, the ARiX RAD Radiographic System, as designed and manufactured by Compañía Mexicana de Radiología, is determined to be substantially equivalent to the Sedecal Millennium Plus Xray system.

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.