RW-1

K232456 · Mediott, Inc. · LLZ · Aug 11, 2025 · Radiology

Device Facts

• Record ID: K232456
• Device Name: RW-1
• Applicant: Mediott, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Aug 11, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

This software is a medical device intended for the evaluation of DICOM images. It receives, stores, processes, and displays sequential DICOM images primarily obtained through low-dose chest fluoroscopy (e.g., RF and AX modalities). This software is not intended to be used for primary diagnosis. Reference images such as scintigraphy or CT scans may be displayed for supplementary purposes.

Device Story

Software-only medical imaging system for COTS PCs; receives, stores, processes, and displays sequential DICOM images from chest fluoroscopy (RF, AX). Operates as standalone application; integrates visualization and processing. Healthcare providers use device to view images and perform area measurements; supports time-series comparison via graph display. Facilitates supplementary review of pulmonary images; not for primary diagnosis. Benefits include streamlined image management and evaluation workflow.

Clinical Evidence

No clinical data. Performance supported by system-level verification and validation (V&V) activities confirming functional correctness, repeatability, and robustness of deterministic software algorithms.

Technological Characteristics

Software-only medical imaging system; runs on COTS PCs. Inputs: DICOM 3.0 (RF, DX, CR, AX). Outputs: DICOM storage. Features: density/gradation adjustment, rotation, scaling, panning, cine/comparison display, time-series graph display, area measurement. Standalone architecture.

Indications for Use

Indicated for the evaluation of pulmonary images in patients undergoing low-dose chest fluoroscopy (RF and AX modalities). Not intended for primary diagnosis.

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

• KONICAMINOLTA DI-X1 (K212685)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

August 11, 2025

Mediott Inc.
Akio Oki
Senior Consultant
18-2 Shitamachi, Akagi Kagura Sacas
SHINJUKU-KU, TOKYO 162-0803
JAPAN

Re: K232456
Trade/Device Name: RW-1
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management And Processing System
Regulatory Class: Class II
Product Code: LLZ
Dated: July 4, 2025
Received: July 7, 2025

Dear Akio Oki:

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 (the 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 available 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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

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K232456 - Akio Oki
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the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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,


Jessica Lamb
Assistant Director, Imaging Software Team
DHT8B: Division of Radiologic 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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# 510(k) Summary

510(k) Number: K232456

Date of Preparation: August 7th, 2025

## Applicant

Company name: Mediott Inc.
Address: Kagura Sacas, 18-2, Akagi-shitamachi, Shunjuku-ku, Tokyo, 162-0803, Japan

## Contact

Contact Person: Akio OKI
Title: Senior Consultant
Phone: [phone]
Fax: None
e-mail: [e-mail]

## Name of Device(s)

Product Name: RW-1
Regulation Name(s): System, Image Processing, Radiological
Classification Name: Medical image management and processing system
Regulation Number: 892.2050
Regulatory Class: II
Product Code: LLZ
Panel: Radiology

## Predicate Device

- KONICAMINOLTA DI-X1 (K212685) by Konica Minolta, Inc.

## Device Description

The subject device is a software-only medical imaging system intended for installation on commercial off-the-shelf personal computers. It receives, stores, processes, and displays sequential DICOM images, primarily obtained from chest fluoroscopy (e.g., RF, AX modalities). The software is compatible with external systems such as hospital PACS via DICOM-compliant communication protocols.

The device operates as a standalone application, with all processing and visualization functionalities integrated into a single software package.

## Indications for Use

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This software is a medical device intended for the evaluation of DICOM images. It receives, stores, processes, and displays sequential DICOM images primarily obtained through low-dose chest fluoroscopy (e.g., RF and AX modalities).

This software is not intended to be used for primary diagnosis. Reference images such as scintigraphy or CT scans may be displayed for supplementary purposes.

# Technological Characteristics

The subject device and the predicate device are both software-based medical imaging systems that receive, process, display, and transmit X-ray digital images.

While there are differences in the number of display functions, measurement tools, and system configuration, the subject device retains the core capabilities necessary for its intended use.

These differences represent either reductions in functionality or architectural simplifications. They do not raise new questions of safety or effectiveness.

| | Subject Device | Predicate Device |
| --- | --- | --- |
| Device Name | RW-1 | KONICAMINOLTA DI-X1 |
| 510(k) number | This submission | K212685 |
| Indications for Use | This software is a medical device intended for the evaluation of pulmonary images. It receives, stores, processes, and displays sequential DICOM images primarily obtained through low-dose chest fluoroscopy (e.g., RF and AX modalities).This software is not intended to be used for primary diagnosis. Reference images such as pulmonary scintigraphy or CT scans may be displayed for supplementary purposes. | KONICAMINOLTA DI-X1 is a software device that receives digital x-ray images and data from various sources (i.e. R/F Units, digital radiographic devices or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and/or across computer networks at distributed locations. It is not intended for use in diagnostic review for mammography |
| Input Image | DICOM 3.0DICOM Modality (RF, DX, CR, AX) | DICOM 3.0DICOM Modality (RF, DX, CR) |
| I/O Data | DICOM Storage | DICOM Storage |
| Display Functions | Adjustment of density and gradation, Rotation, Scaling, PanningScreen display (listing, viewer)Image display (Cine, Comparison)Graph display (Time-series comparison) | Adjustment of density and gradation, Rotation and reversal, Scaling, PanningScreen display (listing, viewer)Image display (Cine, Comparison, Annotation, Overlay) |

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| | | • Graph display (Time-series comparison) |
| --- | --- | --- |
| Measurement Functions | • Area | • Distance
• Angle
• Area
• CTR (Only the image of the front of the chest) |
| Client | • RW-1 client (Standalone application) | • DI-X1 client
• DI-X1 Server client
• PC client (WEB reference) |

# Performance (Non-Clinical) Testing

Non-clinical performance testing was conducted as part of the comprehensive system-level verification and validation (V&V) activities for the subject device. These tests were designed to confirm that the implemented software algorithms operate reliably and consistently under representative conditions. The primary focus was on ensuring functional correctness, repeatability, and robustness of the device functions, consistent with industry standards for software-based medical devices. Statistical exhaustiveness was not required due to the deterministic nature of the implemented algorithms.

No separate standalone bench tests were performed beyond these system-level V&V activities, as the system-level testing was considered sufficient to evaluate all performance-critical features under anticipated use conditions. This approach aligns with standard practices for medical software, where system-level integration tests typically serve as the main source of performance evidence.

Collectively, these results support the conclusion that the subject device performs as intended and is substantially equivalent to the predicate device with respect to safety and effectiveness.

# Conclusion

Based on the comparison of technological characteristics and intended use, as well as non-clinical performance testing, it is concluded that the subject device is substantially equivalent to the predicate device. The observed differences do not raise new questions of safety or effectiveness and reflect reductions in scope or architectural simplification.

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# 510(k) Summary

510(k) Number: K232456

Date of Preparation: August 7th, 2025

## Applicant

Company name: Mediott Inc.
Address: Kagura Sacas, 18-2, Akagi-shitamachi, Shunjuku-ku, Tokyo, 162-0803, Japan

## Contact

Contact Person: Akio OKI
Title: Senior Consultant
Phone: [phone]
Fax: None
e-mail: [e-mail]

## Name of Device(s)

Product Name: RW-1
Regulation Name(s): System, Image Processing, Radiological
Classification Name: Medical image management and processing system
Regulation Number: 892.2050
Regulatory Class: II
Product Code: LLZ
Panel: Radiology

## Predicate Device

- KONICAMINOLTA DI-X1 (K212685) by Konica Minolta, Inc.

## Device Description

The subject device is a software-only medical imaging system intended for installation on commercial off-the-shelf personal computers. It receives, stores, processes, and displays sequential DICOM images, primarily obtained from chest fluoroscopy (e.g., RF, AX modalities). The software is compatible with external systems such as hospital PACS via DICOM-compliant communication protocols.

The device operates as a standalone application, with all processing and visualization functionalities integrated into a single software package.

## Indications for Use

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This software is a medical device intended for the evaluation of DICOM images. It receives, stores, processes, and displays sequential DICOM images primarily obtained through low-dose chest fluoroscopy (e.g., RF and AX modalities).

This software is not intended to be used for primary diagnosis. Reference images such as scintigraphy or CT scans may be displayed for supplementary purposes.

# Technological Characteristics

The subject device and the predicate device are both software-based medical imaging systems that receive, process, display, and transmit X-ray digital images.

While there are differences in the number of display functions, measurement tools, and system configuration, the subject device retains the core capabilities necessary for its intended use.

These differences represent either reductions in functionality or architectural simplifications. They do not raise new questions of safety or effectiveness.

| | Subject Device | Predicate Device |
| --- | --- | --- |
| Device Name | RW-1 | KONICAMINOLTA DI-X1 |
| 510(k) number | This submission | K212685 |
| Indications for Use | This software is a medical device intended for the evaluation of pulmonary images. It receives, stores, processes, and displays sequential DICOM images primarily obtained through low-dose chest fluoroscopy (e.g., RF and AX modalities).This software is not intended to be used for primary diagnosis. Reference images such as pulmonary scintigraphy or CT scans may be displayed for supplementary purposes. | KONICAMINOLTA DI-X1 is a software device that receives digital x-ray images and data from various sources (i.e. R/F Units, digital radiographic devices or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and/or across computer networks at distributed locations. It is not intended for use in diagnostic review for mammography |
| Input Image | DICOM 3.0DICOM Modality (RF, DX, CR, AX) | DICOM 3.0DICOM Modality (RF, DX, CR) |
| I/O Data | DICOM Storage | DICOM Storage |
| Display Functions | Adjustment of density and gradation, Rotation, Scaling, PanningScreen display (listing, viewer)Image display (Cine, Comparison)Graph display (Time-series comparison) | Adjustment of density and gradation, Rotation and reversal, Scaling, PanningScreen display (listing, viewer)Image display (Cine, Comparison, Annotation, Overlay) |

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| | | • Graph display (Time-series comparison) |
| --- | --- | --- |
| Measurement Functions | • Area | • Distance
• Angle
• Area
• CTR (Only the image of the front of the chest) |
| Client | • RW-1 client (Standalone application) | • DI-X1 client
• DI-X1 Server client
• PC client (WEB reference) |

# Performance (Non-Clinical) Testing

Non-clinical performance testing was conducted as part of the comprehensive system-level verification and validation (V&V) activities for the subject device. These tests were designed to confirm that the implemented software algorithms operate reliably and consistently under representative conditions. The primary focus was on ensuring functional correctness, repeatability, and robustness of the device functions, consistent with industry standards for software-based medical devices. Statistical exhaustiveness was not required due to the deterministic nature of the implemented algorithms.

No separate standalone bench tests were performed beyond these system-level V&V activities, as the system-level testing was considered sufficient to evaluate all performance-critical features under anticipated use conditions. This approach aligns with standard practices for medical software, where system-level integration tests typically serve as the main source of performance evidence.

Collectively, these results support the conclusion that the subject device performs as intended and is substantially equivalent to the predicate device with respect to safety and effectiveness.

# Conclusion

Based on the comparison of technological characteristics and intended use, as well as non-clinical performance testing, it is concluded that the subject device is substantially equivalent to the predicate device. The observed differences do not raise new questions of safety or effectiveness and reflect reductions in scope or architectural simplification.