(25 days)
Not Found
No
The summary describes standard image processing techniques and data management features, with no mention of AI, ML, or related concepts like training or test sets for algorithmic performance. The added features (TD-MODE, Position Tracking, Signal Value Change) appear to be rule-based or algorithmic but not explicitly AI/ML.
No
The device is described as a software for image processing and display of X-ray images, intended to assist in diagnostic review, not to provide therapy.
No
Explanation: The "Intended Use" section explicitly states, "It is not intended for use in diagnostic review for mammography." While it processes and displays images from diagnostic modalities, its stated purpose is not direct diagnostic review, particularly for the specified modality.
Yes
The device is explicitly described as a "software device" multiple times and is intended to be installed on "off-the shelf Servers and PCs," indicating it does not include proprietary hardware. Its functions are centered around receiving, processing, displaying, and transmitting digital images and data.
Based on the provided information, the KONICAMINOLTA DI-X1 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The description of the KONICAMINOLTA DI-X1 clearly states that it receives and processes digital x-ray images and data from various imaging sources. X-ray imaging is a non-invasive technique that captures images of the internal structures of the body, not specimens derived from the body.
- The intended use and device description focus on image processing, display, storage, and communication of medical images. These are functions typically associated with medical imaging software and Picture Archiving and Communication Systems (PACS), not IVD devices.
- There is no mention of analyzing biological samples or performing tests on bodily fluids or tissues.
Therefore, the KONICAMINOLTA DI-X1 falls under the category of medical imaging software, not an In Vitro Diagnostic device.
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 Xray 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.
Modifications are made to add the TD-MODE, Position Tracking and Signal Value Change. The TD-MODE is designed to extract the initial contour of the tracheal wall. The TD-MODE also displays the minimum and maximum tracheal diameter in the frame. The subject device also incorporates Position Tracking and Signal Value Change. Position Tracking is used to track the reference point specified in a frame and display a graph of the position change data. Signal Value Change graphically displays the signal value change within the ROI specified in a frame.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital x-ray images (single-frame images, multi-frame images)
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 showed that the predetermined acceptance criteria were met. No clinical studies were required to support the substantial equivalence.
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.
Konica Minolta, Inc. % Jan Maniscalco Executive Vice President QA/RA Konica Minolta Healthcare Americas, Inc. 411 Newark Pompton Turnpike Wayne, New Jersey 07470
Re: K230906
April 25, 2023
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: March 31, 2023 Received: March 31, 2023
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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230906
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) |
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3
Image /page/3/Picture/0 description: The image shows the Konica Minolta logo along with the text "150 YEARS". The Konica Minolta logo consists of a blue sphere with white lines inside and the company name in black letters. The "150 YEARS" text is in black, with the "150" above a blue line and the word "YEARS" below the line.
510(k) Summary
K23xxxx (will be assigned)
| Company: | KONICA MINOLTA, INC.
1 Sakura-machi, Hino-shi, 191-8511 Japan | | |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact: | Tsutomu Fukui
Senior Manager of Regulatory & QMS Division
1 Sakura-machi, Hino-shi, 191-8511 Japan
Telephone: +81 42 589 8429
Email : tsutomu.fukui1@konicaminolta.com | | |
| Date Prepared: | March 31, 2023 | | |
| 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: | K212685 - KONICAMINOLTA DI-X1
KONICA MINOLTA, INC.
Regulation Number: 21 CFR 892.2050
Product Codes: LLZ | | |
Device Description
KONICAMINOLTA DI-X1 is a software device that performs image processing and display using Xray 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.
Giving Shape to Ideas
4
Image /page/4/Picture/0 description: The image shows the Konica Minolta logo and the text "150 YEARS". The Konica Minolta logo is a blue circle with white horizontal lines inside. The text "KONICA MINOLTA" is written in black letters below the logo. To the right of the logo is the number 150 in large black font with the word "YEARS" written below it.
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.
Modifications are made to add the TD-MODE, Position Tracking and Signal Value Change. The TD-MODE is designed to extract the initial contour of the tracheal wall. The TD-MODE also displays the minimum and maximum tracheal diameter in the frame. The subject device also incorporates Position Tracking and Signal Value Change. Position Tracking is used to track the reference point specified in a frame and display a graph of the position change data. Signal Value Change graphically displays the signal value change within the ROI specified in a frame.
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 in diagnostic review for mammography.
Comparison Table
| Subject Device | Predicate Device | |
|---|---|---|
| Device name | KONICAMINOLTA DI-X1 | KONICAMINOLTA DI-X1 |
| Version | 1.30 | 1.20 |
| 510(K) Number | This Submission | K212685 |
| 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 | ● REGIUS | ● REGIUS |
The comparison to the predicate decides was summarized in the Table below.
Giving Shape to Ideas
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Image /page/5/Picture/0 description: The image shows the Konica Minolta logo. The logo consists of a blue globe with white lines on the left and the text "KONICA MINOLTA" below it. To the right of the logo is the number "150" above a line and the word "YEARS" below the line.
| Subject Device | Predicate Device | |
|---|---|---|
| Device name | KONICAMINOLTA DI-X1 | KONICAMINOLTA DI-X1 |
| Version | 1.30 | 1.20 |
| 510(K) Number | This Submission | K212685 |
| Processing | FE-MODE DM-MODE BS-MODE PL-MODE PH-MODE PH2-MODE LM-MODE TD-MODE | FE-MODE DM-MODE BS-MODE PL-MODE Pk to Pk PH-MODE PH2-MODE LM-MODE |
| 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) Graph display the max/min of the | ||
| tracheal diameter including past images | 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) | ||
| Measurement | Distance Angle Area CTR (Only the image of the front of the | |
| chest) Position Tracking, Signal Value Change | Distance Angle Area CTR (Only the image of the front of the | |
| chest) | ||
| Client | DI-X1 client DI-X1 Server client PC client (WEB reference) | DI-X1 client DI-X1 Server client PC client (WEB reference) |
Performance Data
All the verification activities required by the specification and the risk analysis for the KONICAMINOLTA DI-X1 were performed and the results showed 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 principle operations. The technological differences do not raise new issues of safety or effectiveness as compared to its predicate device (K212685). Performance tests demonstrate that the KONICAMINOLTA DI-X1 performs according to specifications and functions
Giving Shape to Ideas
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Image /page/6/Picture/0 description: The image shows the Konica Minolta logo along with the text "150 YEARS". The Konica Minolta logo consists of a blue globe with white horizontal lines and the text "KONICA MINOLTA" in black. The text "150" is in large black font, with a blue line underneath, and the text "YEARS" is in smaller black font below the line. The logo is likely celebrating the 150th anniversary of Konica Minolta.
as intended. All information supporting our assessment is included in the relevant sections of this submission.
Therefore, it is our conclusion that the KONICAMINOLTA DI-X1 is substantially equivalent to the predicate device and does not raise new issues of safety or effectiveness.
Giving Shape to Ideas