(20 days)
Not Found
No
The summary describes standard image processing and display functionalities, data storage, and network communication. There is no mention of AI, ML, deep learning, or any related concepts or performance metrics typically associated with AI/ML devices.
No
The device is a software for processing and displaying medical images, primarily for diagnostic review, not for direct therapeutic intervention.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device "is not intended for use in diagnostic review for mammography." While it processes and displays images from diagnostic modalities, its specified use case does not confirm it is a diagnostic device itself.
Yes
The device is explicitly described as a "software device" in both the Intended Use and Device Description sections. It is intended to be installed on "off-the-shelf Servers and PCs" and performs image processing and display functions. While it interacts with hardware (servers, PCs, imaging modalities), its core functionality and the subject of the 510(k) appear to be the software itself.
Based on the provided information, the KONICAMINOLTA DI-X1 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device receives, stores, communicates, processes, and displays digital x-ray images and data. This is related to medical imaging, not the examination of specimens derived from the human body.
- Device Description: The description reinforces that the device works with X-ray digital images and performs image processing and display. This aligns with medical imaging workflows.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The KONICAMINOLTA DI-X1 deals with medical images, which are generated from within the body using imaging modalities like X-ray.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
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.
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM Modality (RF, DX, CR)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. Performance tests demonstrate that the KONICAMINOLTA DI-X1 performs according to specifications and functions as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
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) 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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."
3
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.
1 Sakura-machi, Hino-shi, Tokyo, 191-8511 Japan | | |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact: | Tsutomu Fukui
Senior Manager of Regulatory & QMS Division
1 Sakura-machi, Hino-shi, Tokyo, 191-8511 Japan
Telephone: +81 42 589 8429
Email : tsutomu.fukui1@konicaminolta.com | | |
| 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
KONICA MINOLTA, INC.
Regulation Number: 21 CFR 892.2050
Regulatory Class: Class II
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.
- Page 1 of 4 -
Giving Shape to Ideas
4
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.
5
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 | ||
| 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. | 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) | ● DICOM 3.0 | |
| ● DICOM Modality (RF, DX, CR) | ||
| I/O Data | ● DICOM Storage | ● DICOM Storage |
| Image | ||
| Processing | ● REGIUS | |
| ● FE-MODE | ||
| ● DM-MODE | ||
| ● BS-MODE | ||
| ● PL-MODE | ||
| ● Pk to Pk | ||
| ● PH-MODE | ||
| ● PH2-MODE | ||
| ● LM-MODE | ● REGIUS | |
| ● FE-MODE | ||
| ● DM-MODE | ||
| ● BS-MODE | ||
| ● PL-MODE | ||
| ● Pk to Pk | ||
| Display | ||
| Functions | ● Adjustment of density and | |
| gradation, Rotation and reversal, | ||
| Scaling, Panning | ||
| ● Screen display (listing, viewer) | ||
| ● Image display (Cine, Comparison, | ||
| Annotation, Overlay) | ||
| ● 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) | ||
| ● Graph display | ||
| Measurement | ● Distance | |
| ● Angle | ||
| ● Area | ||
| ● CTR (Only the image of the front of | ||
| the chest) | ● Distance | |
| ● Angle | ||
| ● Area | ||
| ● CTR | ||
| Client | ● DI-X1 client | |
| ● DI-X1 Server client | ||
| ● PC client (WEB reference) | ● DI-X1 client | |
| ● DI-X1 Server client |
— Page 3 of 4 —
Giving Shape to Ideas
6
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.
Page 4 of 4