(728 days)
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.
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.
The provided FDA clearance letter and 510(k) summary for Mediott Inc.'s RW-1 device do not contain explicit acceptance criteria or results from a study that demonstrates the device meets specific performance criteria in the way typically expected for AI/ML-driven diagnostic devices.
Instead, the submission focuses on establishing substantial equivalence to a predicate device (KONICAMINOLTA DI-X1, K212685) based on technological characteristics and non-clinical performance testing.
Here's a breakdown of the information that can be extracted, and what is missing based on your requested format:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria:
The document does not define explicit, quantitative acceptance criteria for performance metrics like sensitivity, specificity, accuracy, or other clinical outcomes. The "acceptance criteria" are implied to be that the device performs its stated functions reliably and consistently, and that its differences from the predicate do not raise new questions of safety or effectiveness.
Reported Device Performance:
The document does not report quantitative performance metrics for the RW-1 device. The performance is described qualitatively as "functional correctness, repeatability, and robustness of the device functions."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional correctness, repeatability, and robustness of device functions consistent with industry standards for software-based medical devices. | Qualitative Statement: "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." |
| No new questions of safety or effectiveness compared to the predicate device. | Conclusion: "The observed differences do not raise new questions of safety or effectiveness and reflect reductions in scope or architectural simplification." |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Non-clinical performance testing was conducted as part of the comprehensive system-level verification and validation (V&V) activities for the subject device."
- Sample Size for Test Set: Not specified. The document implies that the testing was focused on the system's inherent functions rather than evaluation against a dataset of clinical cases with established ground truth.
- Data Provenance: Not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: None explicitly mentioned.
- Qualifications of Experts: Not applicable, as there's no mention of expert-established ground truth for a test set.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable, as no expert adjudication for a test set is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Human Readers Improvement with AI vs. Without AI Assistance
- MRMC Study: No, an MRMC study was not conducted or reported. This type of study would typically be performed for AI/ML diagnostic aids to assess human reader performance with and without AI assistance.
- Effect Size: Not applicable, as no MRMC study was performed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
The document states: "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 indicates that an "algorithm-only" or "standalone" performance evaluation (in the sense of quantitative clinical performance metrics on a clinical dataset) was not performed. The "standalone application" mentioned in the description refers to the software's architecture, not a standalone performance evaluation.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable. The V&V activities focused on functional correctness of the software's operations (e.g., displaying images, performing measurements) rather than clinical ground truth (e.g., diagnosis confirmed by pathology, expert consensus, or outcomes).
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The RW-1 is described as a medical image management and processing system with specific display and measurement functions. There is no indication that it is an AI/ML device that requires a training set in the conventional sense for learning-based tasks (e.g., disease detection, classification). The "implemented software algorithms" are deterministic.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no indication of a training set or learning-based algorithms.
Summary of Device Nature:
Based on the provided text, the RW-1 device is primarily a medical image management and processing system. Its functions include receiving, storing, processing, and displaying DICOM images, with features like density/gradation adjustment, rotation, scaling, panning, cine display, comparison, and area measurement.
The key phrase "Statistical exhaustiveness was not required due to the deterministic nature of the implemented algorithms" strongly suggests that the RW-1 is developed using traditional, rule-based or deterministic algorithms for image manipulation and display, rather than machine learning algorithms that would typically require large training and test sets and extensive clinical performance evaluations with ground truth. The V&V focused on ensuring these deterministic functions worked correctly and reliably.
U.S. Food & Drug Administration FDA Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.08.00
Silver Spring, MD 20993
www.fda.gov
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.
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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K232456 - Akio Oki Page 2
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 Page 3
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
Page 4
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: +81 70 7793 8055
Fax: None
e-mail: akio.oki@radwisp.com
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
Page 5
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 3.0• DICOM Modality (RF, DX, CR, AX) | • DICOM 3.0• DICOM Modality (RF, DX, CR) |
| I/O Data | • DICOM Storage | • DICOM Storage |
| Display Functions | • Adjustment of density and gradation, Rotation, Scaling, Panning• Screen display (listing, viewer)• Image display (Cine, Comparison)• Graph display (Time-series comparison) | • Adjustment of density and gradation, Rotation and reversal, Scaling, Panning• Screen display (listing, viewer)• Image display (Cine, Comparison, Annotation, Overlay) |
Page 6
| • 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.
Page 7
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: +81 70 7793 8055
Fax: None
e-mail: akio.oki@radwisp.com
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
Page 8
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 3.0• DICOM Modality (RF, DX, CR, AX) | • DICOM 3.0• DICOM Modality (RF, DX, CR) |
| I/O Data | • DICOM Storage | • DICOM Storage |
| Display Functions | • Adjustment of density and gradation, Rotation, Scaling, Panning• Screen display (listing, viewer)• Image display (Cine, Comparison)• Graph display (Time-series comparison) | • Adjustment of density and gradation, Rotation and reversal, Scaling, Panning• Screen display (listing, viewer)• Image display (Cine, Comparison, Annotation, Overlay) |
Page 9
| • 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.
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).