KONICAMINOLTA DI-X1

K212685 · Konica Minolta, Inc. · LLZ · Sep 13, 2021 · Radiology

Device Facts

• Record ID: K212685
• Device Name: KONICAMINOLTA DI-X1
• Applicant: Konica Minolta, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Sep 13, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

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.

Device Story

Standalone software device installed on off-the-shelf servers/PCs; receives digital X-ray images (single/multi-frame) via DICOM 3.0 from imaging modalities. Processes images using various modes (REGIUS, FE, DM, BS, PL, Pk to Pk, PH, PH2, LM); performs measurements (distance, angle, area, CTR). Displays images and chronological measurement graphs for clinical review. Features RAID1 mirroring for data redundancy. Modifications include browser-based PC client for web reference, additional image processing modes, and chronological graph display for exam comparison. Used in clinical environments; operated by healthcare professionals to assist in diagnostic workflows. Benefits include efficient image management, remote access via web client, and longitudinal tracking of patient measurements.

Clinical Evidence

Bench testing only. No clinical studies were required to support substantial equivalence. Verification activities confirmed that all predetermined acceptance criteria were met.

Technological Characteristics

Standalone software for off-the-shelf servers/PCs. Connectivity: DICOM 3.0. Data storage: RAID1 mirroring. Image processing modes: REGIUS, FE-MODE, DM-MODE, BS-MODE, PL-MODE, Pk to Pk, PH-MODE, PH2-MODE, LM-MODE. Measurement tools: distance, angle, area, CTR. Deployment: Server-client architecture with web-based reference capability.

Indications for Use

Indicated for receiving, storing, communicating, processing, and displaying digital X-ray images and data from various diagnostic imaging sources (R/F units, digital radiographic devices). Not intended for diagnostic review of 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

• KONICAMINOLTA DI-X1 (K182431)

Submission Summary (Full Text)

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September 13, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of 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.

Konica Minolta, Inc. % Jan Maniscalco Director of QA/RA Konica Minolta Healthcare Americas, Inc. 411 Newark-Pompton Turnpike WAYNE NJ 07470

Re: K212685

Trade/Device Name: KONICAMINOLTA DI-X1 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: August 16, 2021 Received: August 24, 2021

Dear Jan Maniscalco:

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

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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 ([e-mail]) or phone [phone] 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

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## Indications for Use

510(k) Number (if known) K212685

Device Name KONICAMINOLTA DI-X1

#### Indications for Use (Describe)

KONICAMINOLTA DI-X1 is a software device that receives digital x-ray images and data from various sources (i.e. RF 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.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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Image /page/3/Picture/0 description: The image contains the Konica Minolta logo. The logo features a blue circle with several horizontal white lines across the center. Below the circle, the words "KONICA MINOLTA" are written in a bold, sans-serif font.

# 510(k) Summary K212685

| Company: | KONICA MINOLTA, INC.<br>1 Sakura-machi, Hino-shi, Tokyo, 191-8511 Japan | | |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact: | Tsutomu Fukui<br>Senior Manager of Regulatory & QMS Division<br>1 Sakura-machi, Hino-shi, Tokyo, 191-8511 Japan<br>Telephone: [phone]<br>Email : [e-mail] | | |
| Date Prepared: | September 08, 2021 | | |
| Device Name: | | | |
| Trade Name: | KONICAMINOLTA DI-X1 | | |
| Common Name: | Medical Image Management and Processing System | | |
| Regulation Number: | 21 CFR 892.2050 | | |
| Regulatory Class: | Class II | | |
| Product Code(s): | LLZ | | |
| Predicate Device: | K182431 - KONICAMINOLTA DI-X1<br>KONICA MINOLTA, INC.<br>Regulation Number: 21 CFR 892.2050<br>Regulatory Class: Class II<br>Product Codes: LLZ | | |

## Device Description

KONICAMINOLTA DI-X1 is a software device that performs image processing and display using X-ray digital images (single-frame images, multi-frame images) generated by various diagnostic imaging modality consoles. It is a standalone software device intended to install onto off-the -shelf Servers and PCs.

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Giving Shape to Ideas

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Image /page/4/Picture/0 description: The image shows the logo for Konica Minolta. The logo consists of a blue circle with several horizontal white lines across the middle. Below the circle is the text "KONICA MINOLTA" in a bold, sans-serif font.

KONICAMINOLTA DI-X1 receives X-ray digital images, including serial images, processes the received images, as well as displays and sends the resulting images to PACS and other devices. In addition, KONICAMINOLTA DI-X1 can display images through the browser connection with the client that displays and process images, and instruct transmission of images.

The personal computer used in KONICAMINOLTA DI-X1 stores the same data in two hard disks in real time using RAID1 mirroring function. Thus, even if one hard disk is defective, operations can be continued with the other hard disk which has the same data.

The modifications are made on software to the identified predicate device to add the PC client to connect to the server using the browser on a personal computer to display images for a WEB reference. In addition, additional imaging processing MODES are implemented into the subject device. The subject device also modifies the graphical display to compare the past exam. graphs based on the measurement values in a chronological order.

#### Indications for Use

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.

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Image /page/5/Picture/0 description: The image contains the logo for Konica Minolta. The logo features a blue circle with several horizontal white lines running across the middle. Below the circle, the words "KONICA MINOLTA" are written in a bold, sans-serif font.

## Comparison Table

The comparison to the predicate decides was summarized in the Table below.

| | Subject Device | Predicate Device |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | KONICAMINOLTA DI-X1 | KONICAMINOLTA DI-X1 |
| 510(K) Number | This Submission | K182431 |
| Indications for<br>Use | KONICAMINOLTA DI-X1 is a software<br>device that receives digital x-ray images<br>and data from various sources (i.e. R/F<br>Units, digital radiographic devices or<br>other imaging sources). Images and data<br>can be stored, communicated, processed<br>and displayed within the system and/or<br>across computer networks at distributed<br>locations. It is not intended for use in<br>diagnostic review for mammography. | KONICAMINOLTA DI-X1 is a software<br>device that receives digital x-ray images<br>and data from various sources (i.e. R/F<br>Units, digital radiographic devices or other<br>imaging sources). Images and data can be<br>stored, communicated, processed and<br>displayed within the system and/or across<br>computer networks at distributed<br>locations. It is not intended for use in<br>diagnostic review for mammography. |
| Input image | ● DICOM 3.0<br>● DICOM Modality (RF, DX, CR) | ● DICOM 3.0<br>● DICOM Modality (RF, DX, CR) |
| I/O Data | ● DICOM Storage | ● DICOM Storage |
| Image<br>Processing | ● REGIUS<br>● FE-MODE<br>● DM-MODE<br>● BS-MODE<br>● PL-MODE<br>● Pk to Pk<br>● PH-MODE<br>● PH2-MODE<br>● LM-MODE | ● REGIUS<br>● FE-MODE<br>● DM-MODE<br>● BS-MODE<br>● PL-MODE<br>● Pk to Pk |
| Display<br>Functions | ● Adjustment of density and<br>gradation, Rotation and reversal,<br>Scaling, Panning<br>● Screen display (listing, viewer)<br>● Image display (Cine, Comparison,<br>Annotation, Overlay)<br>● Graph display (Time-series<br>comparison) | ● Adjustment of density and gradation,<br>Rotation and reversal, Scaling,<br>Panning<br>● Screen display (listing, viewer)<br>● Image display (Cine, Comparison,<br>Annotation, Overlay)<br>● Graph display |
| Measurement | ● Distance<br>● Angle<br>● Area<br>● CTR (Only the image of the front of<br>the chest) | ● Distance<br>● Angle<br>● Area<br>● CTR |
| Client | ● DI-X1 client<br>● DI-X1 Server client<br>● PC client (WEB reference) | ● DI-X1 client<br>● DI-X1 Server client |

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Giving Shape to Ideas

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Image /page/6/Picture/0 description: The image contains the Konica Minolta logo. The logo features a blue globe-like shape at the top with several horizontal white lines running across it. Below the globe is the text "KONICA MINOLTA" in a simple, sans-serif font.

#### Performance Data

All the verification activities required by the specification and the risk analysis for the KONICAMINOLTA DI-X1 were performed and the results demonstrated that the predetermined acceptance criteria were met. No clinical studies were required to support the substantial equivalence.

## Conclusion

KONICAMINOLTA DI-X1 has the same intended use and indications for use, technological characteristics, and principal operations. The technological differences raised no new issues of safety or effectiveness as compared to its predicate device (K182431). Performance tests demonstrate that the KONICAMINOLTA DI-X1 performs according to specifications and functions as intended. All the information to demonstrate assurance of our evaluation is attached to relevant sections of this submission.

Therefore, as for our conclusion, the KONICAMINOLTA DI-X1 is substantially equivalent to the predicate device and presents no new questions of safety or effectiveness.

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