(112 days)
Not Found
No
The summary describes a standard radiographic system and does not mention any AI or ML capabilities, image processing, or related performance metrics.
No.
The device is described as a "radiographic system used for producing X-ray images" and specifically for "diagnostic imaging", which means it is used for diagnosis, not therapy.
Yes
The "Device Description" explicitly states that the ARiX RAD Radiographic System is a "general purpose, computed radiography (CR) X-ray system used for diagnostic imaging".
No
The device description explicitly states it is a "radiographic system" and a "general purpose, computed radiography (CR) X-ray system," which are hardware components. It also mentions interfacing with digital detectors and external triggering devices, further indicating it is not software-only.
Based on the provided information, the ARIX RAD system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This typically involves tests performed on blood, urine, tissue, or other bodily fluids or substances outside of the body.
- The ARIX RAD system is a radiographic system. Its intended use is to produce X-ray images of the human body directly, without the need for collecting and analyzing specimens. It's a medical imaging device used for diagnostic purposes, but it operates by generating and detecting X-rays that pass through the patient's body.
The description clearly states its function is to produce X-ray images of anatomical regions of the human body. This aligns with the definition of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications 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 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.)
Product codes
KPR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human body, including all anatomical regions such as the head, thorax, column, abdomen, extremities and internal organs.
Indicated Patient Age Range
Adults and pediatric patients:
- 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.)
Intended User / Care Setting
Not Found
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
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.
Non-Clinical Performance Data:
- 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)
- ISO 10993-10 (irritation) (passed required testing)
- ISO 10993-10 (sensitization) (passed required testing)
Internal quality assurance and quality control measures:
- 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:
- 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
- Pediatric Information for X-ray Imaging Device Premarket Notifications
- Content of Premarket Submissions for Management of Cybersecurity in o Medical Devices
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left, and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
2
Indications for Use
510(k) Number (if known) K182134
Device Name ARiX RAD Radiographic System
Indications for Use (Describe)
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.)
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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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
4
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
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.
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 de | ||
| Radiología (CMR) | Sedecal S.A. | na | |
| Device Name | ARIX RAD Radiographic | ||
| System | 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 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 | |||
| 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 | |||
| follow: | |||
| Child (3-12 yrs.), | |||
| approximately 12kg (26 lb.) to | |||
| 51kg (114 lb.)Adolescent (12-21 | |||
| yrs.), approximately 51kg (114 | |||
| lb.) to 80kg (176lb.) | These Digital Radiographic | ||
| Systems are 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. | Similar. Both the subject | ||
| and predicate device | |||
| have the same intended | |||
| use as general-purpose | |||
| diagnostic radiographic | |||
| systems 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, and | |||
| are indicated for use on | |||
| adult, adolescent, and | |||
| pediatric patients. | |||
| Technology | |||
| Overview | General diagnostic X-ray | ||
| system consisting of a tube- | |||
| head and collimator assembly, | |||
| with a generator, generator | |||
| control, and an X-ray table. | General diagnostic X-ray | ||
| system consisting of a tube- | |||
| head and collimator | |||
| assembly, with a generator, | |||
| generator control, and an X- | |||
| ray table. | Same. Both the subject | ||
| and predicate device are | |||
| a general type | |||
| radiographic system | |||
| used for producing | |||
| diagnostic X-ray images | |||
| of the human body, are | |||
| of similar design and | |||
| consist of essentially the | |||
| same types of | |||
| subcomponents and | |||
| operate using the same | |||
| Attribute | Subject Device | Predicate Device | Comparison |
| Mechanism of | |||
| Action | 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 | ||
| Anatomical | |||
| Location | Full body | Full body | Same |
| Power Supply | 220 VCA | 220 VCA | Same |
| Generator | High frequency: 32, 50, 60 and | ||
| 80 kW (made by CMR) | High frequency: 50 - 80 kW | ||
| (made by Sedecal) | Similar. The minor | ||
| difference between the | |||
| smaller generator size | |||
| offered by CMR (32 kW) | |||
| does not raise any new | |||
| questions of safety and | |||
| effectiveness between | |||
| the subject and | |||
| predicate device, as the | |||
| subject device has | |||
| successfully passed | |||
| electrical safety testing | |||
| per 60601-1. | |||
| Exposure Voltage | |||
| Ranges for | |||
| Available | |||
| Generators | 40 - 125 kVp or 40 - 150 kV | 40 - 125 kV or 40 - 150 kV | Same |
| X-ray Current for | |||
| Available | |||
| Generators | 400 - 800 mA | 100 - 300 mA | Similar. The differences |
| in the X-ray current | |||
| produced by the | |||
| generators made by | |||
| CMR do not raise any | |||
| new questions of safety | |||
| and effectiveness | |||
| between the subject and | |||
| predicate device, as the | |||
| subject device has | |||
| successfully passed | |||
| electrical safety testing | |||
| per IEC 60601-1, and IEC | |||
| 60601-2-54. | |||
| X-ray Exposure | |||
| Times | 0.001 - 10 s | 0.001 - 10 s | Same |
| Attribute | Subject Device | Predicate Device | Comparison |
| Controlled | |||
| Design and | |||
| Performance | 21 CFR 1020.30 | ||
| 21 CFR 1020.31 | 21 CFR 1020.30 | Same | |
| Electrical Safety | |||
| and EMC | IEC 60601-1 | ||
| IEC 60601-1-2 | |||
| IEC 60601-2-54 | |||
| (passed TUV) | IEC 60601-1 | ||
| (passed) | Same |
Table 5-1 – Comparison of Device Characteristics
5
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7
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.