← Product Code [KPR](/productcode/KPR) · K193637 # MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System (K193637) _Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. · KPR · Jan 28, 2020 · Radiology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K193637 ## Device Facts - **Applicant:** Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. - **Product Code:** [KPR](/productcode/KPR.md) - **Decision Date:** Jan 28, 2020 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 892.1680 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Pediatric ## Indications for Use The MRH ALFA 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 MRH ALFA radiographic system. The acquisition system comes as a separate system. The MRH ALFA system is not intended for use in mammography, fluoroscopy or angiography. The MRH ALFA system is intended for adults and pediatric patients. The pediatric population is as follow: 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.) The MRH II 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 MRH II radiographic system. The acquisition system comes as a separate system. The MRH II system is not intended for use in mammography, fluoroscopy or angiography. The MRH II system is intended for adults and pediatric patients. The pediatric population is as follow: 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.) The MRH IIE 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 MRH IIE radiographic system. The acquisition system comes as a separate system. The MRH IIE system is not intended for use in mammography, fluoroscopy or angiography. The MRH IIE system is intended for adults and pediatric patients. The pediatric population is as follow: 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 Story General purpose radiographic systems; produce X-ray images of human body; used with conventional film or CR systems; interfaceable with digital detectors (detectors/acquisition systems not included). Components: X-ray tube (dual focal spot), generator, collimator, table, tube stand, wall bucky. Operated by healthcare professionals in clinical settings; patient positioned sitting, standing, or prone/supine. Device produces low radiation dose; output used by clinicians for diagnostic imaging. Modifications from predicate (K182134) include: removal of control panel touch screen; changes to table dimensions, load capacity, and motorized movement; changes to tube stand height and displacement; change to wall bucky casing material. ## Clinical Evidence No clinical data. Substantial equivalence supported by non-clinical bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), radiation safety (IEC 60601-1-3), usability (IEC 60601-1-6), and biocompatibility (ISO 10993-1, -5, -10). ## Technological Characteristics Stationary X-ray system; high-frequency generator (32-80 kW); dual focal spot X-ray tube; manual collimator; 220 VCA power. Compliance: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-54, ISO 10993. Software-controlled. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - ARiX RAD Radiographic System ([K182134](/device/K182134.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Compania Mexicana De Radiologia CGR, S.A. DE C.V. % Mr. Stuart R. Goldman Senior Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Bldg. 1, Suite 300 AUSTIN TX 78746 January 28, 2020 ## Re: K193637 Trade/Device Name: MRH ALFA, MRH II & MRH IIE Radiographic Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR Dated: December 19, 2019 Received: December 27, 2019 ## Dear Mr. 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. 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K193637 Device Name MRH ALFA, MRH II & MRH IIE Radiographic Systems #### Indications for Use (Describe) 1. The MRH ALFA 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 MRH ALFA radiographic system. The acquisition system comes as a separate system. The MRH ALFA system is not intended for use in mammography, fluoroscopy or angiography. The MRH ALFA system is intended for adults and pediatric patients. The pediation is as follow: - · 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.) 2. The MRH II 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 MRH II radiographic system. The acquisition system comes as a separate system. The MRH II system is not intended for use in mammography, fluoroscopy or angiography. The MRH II system is intended for adults and pediatric patients. The pediatric population is as follow: - · 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.) 3. The MRH IIE 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 MRH IIE radiographic system. The acquisition system comes as a separate system. The MRH IIE system is not intended for use in mammography, fluoroscopy or angiography. The MRH IIE system is intended for adults and pediatric patients. The pediatric population is as follow: - · 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) {3}------------------------------------------------ #### 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." {4}------------------------------------------------ # Special 510(k) Summary MRH ALFA, MRH II & MRH IIE Radiographic Systems ## 1. Submission Sponsor Compañía Mexicana de Radiología CGR S.A. de C.V. Fraccionamiento Industrial la Noria s/n El Marqués, Querétaro C.P. 76240 México Phone: (55) 54821300 Contact: Tonatiuh Monroy Soberón Title: Design Engineer, Regulatory Specialist ## 2. Submission Correspondent Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327-9997 Email: LST.AUS.ProjectManagement@ul.com Contact: Stuart R. Goldman Title: Sr. Consultant RA/QA #### 3. Date Prepared December 19, 2019 #### 4. Purpose of the Submission In this Special 510(k) Compañía Mexicana de Radiología (CMR) is making several minor technological modifications to certain components of their previously cleared ARiX RAD Radiographic System (K182134), the predicate device, that will result in the creation of their new MRH ALFA, MRH IIE Radiographic Systems. #### 5. Device Identification | Trade Name: | MRH ALFA, MRH II & MRH IIE Radiographic Systems | |-----------------------|-------------------------------------------------| | 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}------------------------------------------------ ## 6. Legally Marketed Predicate Device | Device name: | ARiX RAD Radiographic System | |---------------|--------------------------------------------------| | 510(k) No.: | K182134 | | Manufacturer: | Compañía Mexicana de Radiología CRG S.A. de C.V. | ## 7. Indications for Use The indications for use on subject devices are identical to the predicate device, the ARiX RAD Radiographic System, as shown below. The MRH ALFA 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 MRH ALFA radiographic system. The acquisition system comes as a separate system. The MRH ALFA system is not intended for use in mammography, fluoroscopy or angiography. The MRH ALFA 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.) The MRH II 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 MRH II radiographic system. The acquisition system comes as a separate system. The MRH II system is not intended for use in mammography, fluoroscopy or angiography. The MRH II 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.) The MRH IIE 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 MRH IIE radiographic system. The acquisition system comes as a separate system. The MRH IIE system is not intended for use in mammography, fluoroscopy or angiography. {6}------------------------------------------------ The MRH IIE 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.) #### 8. Device Description The MRH ALFA, MRH II & MRH IIE Radiographic Systems designed and manufactured by CMR are general purpose, computed radiography (CR) X-ray systems 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 devices are designed to meet the requirements of basic radiology procedures and produces a low radiation dose to the patient, while acquiring its images. ## 9. Device Modifications The following minor technological modifications have been made to the ARiX RAD Radiographic System (K182134), the predicate device. The minor modifications are being made to several main components of the predicate device to create the subject devices. The minor modifications are: 1) removal of the touch screen functionality from the Control Panel, 2) change the dimensions, load capacity and motorized movement feature of the Powered Table Top, 3) change the height, longitudinal displacement and vertical displacement of the X-ray Tube Stand and 4) change the casing material for the Wall Bucky. In addition, the name of the device is also being changed from the ARiX RAD Radiographic System to the MRH ALFA, MRH II & MRH IIE Radiographic Systems to reflect these different changes for marketing purposes. #### 10. Substantial Equivalence Comparison Table 5-1 compares the MRH ALFA, MRH IIE Radiographic Systems subject devices to the predicate device ARiX RAD Radiographic System with respect to indications for use, principles of operation, technological characteristics, components/materials, and performance testing. The comparison of the subject devices to the predicate device provides detailed information regarding the basis for the determination of substantial equivalence. The subject devices do not raise any new issues of safety or effectiveness based on the similarities to the predicate device. {7}------------------------------------------------ | Attributes | Subject Devices | Predicate Device | Comparison | |--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Device Name | MRH ALFA, MRH II & MRH IIE Radiographic Systems | ARIX RAD Radiographic System | - | | Manufacturer | Compañía Mexicana de Radiología (CMR) | Compañía Mexicana de Radiología (CMR) | Same | | 510(k) # | Pending | K182134 | - | | | Regulatory Information | | | | Product Code | KPR | KPR | Identical | | Regulation | CFR 892.1680 | CFR 892.1680 | Identical | | Regulation Name | Stationary x-ray system | Stationary x-ray system | Identical | | Class | II | II | Identical | | Review Panel | Radiology | Radiology | Identical | | Intended Use | Radiographic system used for producing X-ray images of | Radiographic system used for producing X-ray images of | Identical | | | the human body. | the human body. | | | Indications for Use | The MRH ALFA 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 MRH ALFA radiographic system. The
acquisition system comes as a separate system.
The MRH ALFA system is not intended for use in
mammography, fluoroscopy or angiography.
The MRH ALFA 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.)
The MRH II system is a radiographic system used for | 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 follows:
• Child (3-12 yrs.), approximately 12kg (26 lb.) to
51 kg (114 lb.)
• Adolescent (12-21 yrs.), approximately 51kg (114
lb.) to 80kg (176 lb.) | Identical | | Attributes | Subject Devices | Predicate Device | Comparison | | | 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 MRH II radiographic system. The acquisition
system comes as a separate system. | | | | | The MRH II system is not intended for use in
mammography, fluoroscopy or angiography. | | | | | The MRH II 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.) | | | | | The MRH IIE 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 MRH IIE radiographic system. The acquisition
system comes as a separate system. | | | | | The MRH IIE system is not intended for use in
mammography, fluoroscopy or angiography. | | | | | The MRH IIE 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.) | | | | Attributes | Subject Devices | Predicate Device | Comparison | | | Adolescent (12-21 yrs.), approximately 51 kg (114 lb.) to 80 kg (176 lb.) | | | | 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. | Identical | | Mechanism of Action | X-ray tube
(Dual Focal Spot) | X-ray tube
(Dual Focal Spot) | Identical | | Configuration | Column mount | Column mount | Identical | | Positioning Controls | Enhanced | Enhanced | Identical | | Collimator | Manual
(made by Ralco) | Manual
(made by Ralco) | Identical | | Anatomical Location | Full body | Full body | Identical | | Power Supply | 220 VCA | 220 VCA | Identical | | Generator | High frequency: 32, 50, 60 and 80 kW
(made by CMR) | High frequency: 32, 50, 60 and 80 kW
(made by CMR) | Identical | | Exposure Voltage Ranges for Available Generators | 40 - 125 kVp or 40 - 150 kVp… --- **Source:** [https://fda-staging.innolitics.com/device/K193637](https://fda-staging.innolitics.com/device/K193637) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com