AXIR-CX

K213520 · Radisen Co., Ltd. · LLZ · Aug 19, 2022 · Radiology

Device Facts

• Record ID: K213520
• Device Name: AXIR-CX
• Applicant: Radisen Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Aug 19, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

AXIR-CX is a software package used with general purpose computing hardware to receive, store, distribute and display chest X-ray images and associated data for patient diagnosis. AXIR-CX is a software application that enable the DICOM-compliant chest X-ray image [14 x 17 or 17 x 17 inch size] from DR and CR, and after image displaying the user adds the annotation regarding the diagnosis and print out the patient information or send to another PACS system. AXIR-CX is intended to be used by trained medical professionals including physicians, radiologists, and medical technicians. This device is not indicated for use in mammography.

Device Story

AXIR-CX is a software application installed on general-purpose PCs for managing chest X-ray images. It receives DICOM-compliant images from DR and CR detectors; allows users to review images; enables manual annotation for diagnostic purposes; and supports printing or transmission to other PACS systems. Used by physicians, radiologists, and medical technicians in clinical environments. The device facilitates clinical decision-making by providing a platform for image visualization and documentation. It does not perform automated image processing or measurements.

Clinical Evidence

No clinical data. Bench testing only. Validation performed via risk management assessment in accordance with EN ISO 14971:2012, EN 62304:2006+AC:2008, EN 62366:2008, and EN ISO 13485:2016/AC2016. Software verification and validation conducted per IEEE 1012-2012.

Technological Characteristics

Software-only medical device for Windows 10. Operates on general-purpose computing hardware. Supports DICOM 3.0 standard for image archiving, query/retrieve, and printing. No automated image processing, measurement, or analysis tools. Complies with EN ISO 14971, EN 62304, EN 62366, and EN ISO 13485 standards.

Indications for Use

Indicated for trained medical professionals (physicians, radiologists, medical technicians) to receive, store, distribute, and display DICOM-compliant chest X-ray images (14x17 or 17x17 inch) from DR and CR systems for diagnosis and annotation. Not indicated for mammography.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• ExamVue PACS (K162868)

Submission Summary (Full Text)

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August 19, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an abstract design, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" in a larger font and enclosed in a blue square.

Radisen Co., Ltd. % Dave Kim Medical Device Regulatory Affairs Mtech Group 7505 Fannin St. , Suite 610 HOUSTON TX 77054

Re: K213520

Trade/Device Name: AXIR-CX Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: July 20, 2022 Received: July 20, 2022

Dear Dave Kim:

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 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K213520

Device Name AXIR-CX

Indications for Use (Describe)

AXIR-CX is a software package used with general purpose computing hardware to receive, store, distribute and display chest X-ray images and associated data for patient diagnosis.

AXIR-CX is a software application that enable the DICOM-compliant chest X-ray image [14 x 17 or 17 x 17 inch size] from DR and CR, and after image displaying the user adds the annotation regarding the diagnosis and print out the patient information or send to another PACS system. AXIR-CX is intended to be used by trained medical professionals including physicians, radiologists, and medical technicians. This device is not indicated for use in mammography.

| Type of Use (Select one or both, as applicable) | <div> <input type="checkbox"/> </div> |
|-------------------------------------------------|---------------------------------------|
| | <div> <input type="checkbox"/> </div> |

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 1. Traditional 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR Part 807.92.

Date 510K summary prepared: August 18, 2022

| Submitter's Name: | Radisen Co., Ltd. |
|-------------------------|---------------------------------------------------------------------------------------------------------|
| Submitter's Address: | B-602, Hifield Building, 66, Beolmal-ro, Dongan-gu, Anyang-si,<br>Gyeonggi-do, Republic of Korea, 14058 |
| Submitter's Telephone: | Tel:[phone] |
| Contact person: | Mr. John Lim / EVP of DR Business Unit |
| Official Correspondent: | Dave Kim ([e-mail]) |
| Address: | 7505 Fannin St. Ste 610, Houston, TX 77054 |
| Telephone: | [phone] |

Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known:

| Trade/proprietary name: | AXIR-CX |
|-------------------------|---------------------------------------------------|
| Regulation Name: | Medical image management and processing system |
| Regulation Number: | 21 CFR 892.2050 |
| Regulatory Class: | II |
| Product Code: | LLZ |
| Predicate Device | |
| Manufacturer: | JPI Healthcare Co., Ltd |
| Device: | ExamVue PACS |
| 510(k) Number: | K162868 |
| Classification Name: | Imaging Processing System, Radiological |
| Common Name: | Picture Archiving and Communication System (PACS) |
| Regulatory Number: | 21 CFR 892. 2050 |
| Regulatory Class: | II |
| Product Code: | LLZ |

## 2. Device Description

The AXIR software is designed for use by radiologists and radiology technicians for annotation in the Chest X-ray images. The AXIR software is developed to use Radisen Flat Panel DR Detector and Radisen Image Viewer. The purpose of AXIR software is for the doctor to annotate Chest X-ray images and then to print out with patient information or sent to another PACS system.

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A client user needs to install AXIR-CX first in the recommended PC environment. After installation, the client user chooses a DICOM format in the uploaded patient list to be annotated, and then annotation is written by user after reviewing of image chosen. After annotation has completed it can be printed out, saved or sent to another PACS system.

## 3. Indications for Use

AXIR-CX is a software package used with general purpose computing hardware to receive, store. distribute and display chest X-ray images and associated data for patient diagnosis. AXIR-CX is a software application that enable the DICOM-compliant chest X-ray image [14 x 17 or 17 x 17 inch size] from DR and CR, and after image displaying the user adds the annotation regarding the diagnosis and print out the patient information or send to another PACS system. AXIR-CX is intended to be used by trained medical professionals including physicians, radiologists, and medical technicians. This device is not indicated for use in mammography.

#### 4. Summary of Design Control Risk management

After the analysis of risk management, there are no more risk factors and no more actions neede deither. Risk management, during the life cycle from product planning, design process to followup management, identified foreseeable risks in accordance with EN ISO 14971:2012, EN 62304:2006+AC:2008, EN 62366:2008 and EN ISO 13485:2016/AC2016 standards. The validation of risk management was performed by the radiologist who had the experience in clinical field according to the risk management plan. Each item of the validation was checked, and the system had no risks.

## 5. Comparison with predicate device:

Radisen Co., Ltd, believes that AXIR-CX is substantially equivalent to the predicate device, ExamVue PACS.

Both the subject and predicate devices have the same basic structure (a central server database and associated viewers), function (the storage, display of DICOM images) and follow the DICOM They have similar intended uses and provide similar suites of tools to fulfil their protocol. function.

AXIR-CX differs from the predicate device is user interface and compatible operating system. We believe this does not represent a substantial difference between the two devices, as the change in system requirements reflect the change in computer technology since the release of the predicate device, and the user interface presents the same essential data and supports similar workflow as the predicate device.

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# 6. Substantial Equivalence

| Characteristic | Proposed<br>AXIR-CX | Predicate Device<br>ExamVue PACS | Remark |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Manufacturer | Radisen Co., Ltd | JPI Healthcare Co., Ltd | |
| 510(k) number | K213520 | K162868 | |
| Intended Use | AXIR-CX is a software<br>application that enable the<br>DICOM-compliant chest X-ray<br>image [14 x 17 or 17 x 17 inch<br>size] from DR and CR, and after<br>image displaying the user adds<br>the annotation regarding the<br>diagnosis and print out the<br>patient information or send to<br>another PACS system. AXIR-CX<br>is intended to be used by<br>trained medical professionals<br>including physicians,<br>radiologists, and medical<br>technicians. This device is not<br>indicated for use in<br>mammography. | ExamVue PACS is an image<br>management system intended<br>to be used by trained<br>professionals, including<br>physicians, radiologists, nurses<br>and medical technicians.<br>The software is a software<br>package used with general<br>purpose computing hardware<br>to receive, store, distribute,<br>process and display images<br>and associated data throughout<br>a clinical environment. The<br>software performs digital image<br>processing, measurement,<br>communication and storage.<br>This device is not indicated for<br>use in mammography.<br>ExamVue PACS supports<br>receiving, sending, printing,<br>storing and displaying studies<br>received from the following<br>modality types via DICOM: CR<br>and DX. | Similarity |
| Performance<br>Standard | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| Operating<br>System<br>Requirement | Window 10 and<br>based<br>Window<br>operating system | Window 7 or<br>Window 8 or<br>Window 10 | Similarity |
| Imaging<br>Archive | Yes<br>(DICOM 3.0 Standard) | Yes<br>(DICOM 3.0 Standard) | Same |
| Image display | Yes | Yes | Same |
| Patient Search | Yes | Yes | Same |
| Distance<br>and<br>Angle<br>Measurement | No | Yes | Difference |
| Window<br>Level<br>Adjustment | No | Yes | Difference |
| Zoom<br>and<br>Magnify<br>Function | No | Yes | Difference |
| Line Profile and<br>Histogram | No | Yes | Difference |
| DICOM<br>Directory<br>Reading | Yes | Yes | Same |
| DICOM<br>Query/Retrieve | Yes | Yes | Same |
| DICOM Import | No | Yes | Same |
| DICOM CD burn | No | Yes | Difference |
| Annotation | Yes | Yes | Same |
| DICOM Print | Yes | Yes | Same |
| DICOM<br>Tag<br>Display | No | Yes | Difference |
| Patient<br>Information<br>Editing | No | Yes | Difference |

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There is no significant difference between AXIR-CX and the predicate device that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function and operational principles and intended use.

# 7. Safety, EMC and Performance Data

Safety testing and documentation was performed in accordance with IEEE 1012-2012, Standard for System and Software Verification and Validation. [AXIR-CX-SVR]

## 8. Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Radisen Co., Ltd, concludes that AXIR-CX is safe and effective and substantially equivalent to predicate device as described herein.