K Number
K210066
Device Name
ImagePilot
Date Cleared
2021-05-06

(115 days)

Product Code
Regulation Number
892.2050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ImagePilot software is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications. The ImagePilot software primarily facilitates processing and presentation of medical images on display monitors suitable for the medical task being performed. The ImagePilot software can process and display medical images from the following modality types: Plain X-ray Radiography, X-ray Computed Tomography, Magnetic Resonance imaging, Ultrasound, Nuclear Medicine and other DICOM compliant modalities. The ImagePilot must not be used for primary image diagnosis in mammography.
Device Description
The ImagePilot software is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications. The ImagePilot software primarily facilitates processing and presentation of medical images on display monitors suitable for the medical diagnostics task being performed. The ImagePilot software can process and display medical images from the following modality types: Plain X-ray Radiography, X-ray Computed Tomography, Magnetic Resonance imaging, Ultrasound, Nuclear Medicine and other DICOM compliant modalities including mammography. When used for mammography the ImagePilot should never be used as a diagnostic tool.
More Information

No
The summary focuses on image processing and presentation, and there is no mention of AI, ML, or related concepts. The performance studies section also does not describe any AI/ML-specific validation.

No.
The software processes and presents medical images for diagnostic tasks, but it does not provide any form of treatment or therapy.

No

This device is described as software that "primarily facilitates processing and presentation of medical images," and explicitly states that it "must not be used for primary image diagnosis in mammography" and "should never be used as a diagnostic tool" when used for mammography. This indicates it is not a diagnostic device itself, but rather a tool for displaying and processing images that may be used in a diagnostic context.

Yes

The device is described as "ImagePilot software" intended for installation on an off-the-shelf PC. The description focuses solely on the software's functions (processing and presentation of medical images) and does not mention any proprietary hardware components included with the device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device function: The ImagePilot software processes and presents medical images from various imaging modalities (X-ray, CT, MRI, Ultrasound, Nuclear Medicine). It works with images generated outside the body, not with samples taken from the body.
  • Intended Use: The intended use clearly states it facilitates processing and presentation of medical images for diagnostic tasks, not for analyzing biological samples.
  • Device Description: The description reinforces its function as image processing and display software.

Therefore, the ImagePilot software falls under the category of medical imaging software, not in vitro diagnostics.

N/A

Intended Use / Indications for Use

The ImagePilot software is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications. The ImagePilot software primarily facilitates processing and presentation of medical images on display monitors suitable for the medical task being performed. The ImagePilot software can process and display medical images from the following modality types: Plain X-ray Radiography, X-ray Computed Tomography, Magnetic Resonance imaging, Ultrasound, Nuclear Medicine and other DICOM compliant modalities. The ImagePilot must not be used for primary image diagnosis in mammography.

Product codes (comma separated list FDA assigned to the subject device)

LLZ

Device Description

The ImagePilot software is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications. The ImagePilot software primarily facilitates processing and presentation of medical images on display monitors suitable for the medical diagnostics task being performed. The ImagePilot software can process and display medical images from the following modality types: Plain X-ray Radiography, X-ray Computed Tomography, Magnetic Resonance imaging, Ultrasound, Nuclear Medicine and other DICOM compliant modalities including mammography. When used for mammography the ImagePilot should never be used as a diagnostic tool.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Plain X-ray Radiography, X-ray Computed Tomography, Magnetic Resonance imaging, Ultrasound, Nuclear Medicine and other DICOM compliant modalities.

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 ImagePilot were performed and the results demonstrated 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.

K071436, K133730

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.

K182431

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

May 6, 2021

Image /page/0/Picture/1 description: The image contains 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 is 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. % Ms. Jan Maniscalco Director of QA/RA Konica Minolta Healthcare Americas, Inc. 411 Newark-Pompton Turnpike WAYNE NJ 07470

Re: K210066

Trade/Device Name: ImagePilot Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management and Processing System Regulatory Class: Class II Product Code: LLZ Dated: April 7, 2021 Received: April 8, 2021

Dear Ms. 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 801) medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices

1

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) K210066

Device Name ImagePilot

Indications for Use (Describe)

The ImagePilot software is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications. The ImagePilot software primarily facilitates processing and presentation of medical images on display monitors suitable for the medical task being performed. The ImagePilot software can process and display medical images from the following modality types: Plain X-ray Radiography, X-ray Computed Tomography, Magnetic Resonance imaging, Ultrasound, Nuclear Medicine and other DICOM compliant modalities. The ImagePilot must not be used for primary image diagnosis in 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 consists of a blue globe-like shape with horizontal white lines running across it. Below the globe, the words "KONICA MINOLTA" are written in a bold, sans-serif font.

510(k) Summary K210066

| 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: | May 06, 2021 | | |
| Device Name: | | | |
| Trade Name: | ImagePilot | | |
| Version: | Version 1.92 | | |
| Common Name: | Medical Image Management and Processing System | | |
| Regulation Number: | 21 CFR 892.2050 | | |
| Regulatory Class: | Class II | | |
| Product Code(s): | LLZ | | |
| Primary Predicate Device: | K071436 | REGIUS Unitea
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
Regulation Number: 21 CFR 892.2050
Product Codes: LLZ | |
| Secondary Predicate Device: | K133730 | CO Pilot/REGIUS Unitea
KONICA MINOLTA, INC.
Regulation Name: 21 CFR 892.2050
Product Codes: LLZ | |

Device Description

The ImagePilot software is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications. The ImagePilot software primarily facilitates

— Page 1 of 4 ——

Giving Shape to Ideas

4

Image /page/4/Picture/0 description: The image contains the Konica Minolta logo. The logo consists of a blue sphere with white horizontal lines across the center. Below the sphere, the words "KONICA MINOLTA" are written in a bold, sans-serif font.

processing and presentation of medical images on display monitors suitable for the medical diagnostics task being performed. The ImagePilot software can process and display medical images from the following modality types: Plain X-ray Radiography, X-ray Computed Tomography, Magnetic Resonance imaging, Ultrasound, Nuclear Medicine and other DICOM compliant modalities including mammography. When used for mammography the ImagePilot should never be used as a diagnostic tool.

Indications for Use

The ImagePilot software is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications. The ImagePilot software primarily facilitates processing and presentation of medical images on display monitors suitable for the medical task being performed. The ImagePilot software can process and display medical images from the following modality types: Plain X-ray Radiography, X-ray Computed Tomography, Magnetic Resonance imaging, Ultrasound, Nuclear Medicine and other DICOM compliant modalities. The ImagePilot must not be used for primary image diagnosis in mammography.

Comparison Table
--------------------
Subject DevicePredicate Device 1 (PD1)Predicate Device 2 (PD2)
ImagePilotREGIUS UniteaCO Pilot/REGIUS Unitea
510(K) NumberK210066K071436K133730
Indications for
UseThe ImagePilot software
is intended for installation
on an off-the-shelf PC
meeting or exceeding
minimum specifications.
The ImagePilot software
primarily facilitates
processing and
presentation of medical
images on display
monitors suitable for the
medical task being
performed. The
ImagePilot software can
process and display
medical images from the
following modality types:
Plain X-ray Radiography,The REGIUS Unitea
software is intended for
installation on an off-the-
shelf PC meeting or
exceeding minimum
specifications. The
REGIUS Unitea software
primarily facilitates
processing and
presentation of medical
images on display
monitors suitable for the
medical task being
performed. The REGIUS
Unitea software can
process and display
medical images from the
following modality types:The CO pilot is intended
for installation on an off-
the-shelf PC (REGIUS
Unitea /510(K) number:
K071436) meeting or
exceeding minimum
specifications. The CO
pilot software primarily
facilitates processing and
presentation of medical
images on display
monitors suitable for the
medical task being
performed. The CO pilot
software can process and
display images from the
following modality types:
Plain X-ray Radiography,
Subject DevicePredicate Device 1 (PD1)Predicate Device 2 (PD2)
ImagePilotREGIUS UniteaCO Pilot/REGIUS Unitea
510(K) NumberK210066K071436K133730
X-ray Computed
Tomography, Magnetic
Resonance imaging,
Ultrasound, Nuclear
Medicine and other
DICOM compliant
modalities. The
ImagePilot must not be
used for primary image
diagnosis in
mammography.Plain X-ray Radiography,
X-ray Computed
Tomography, Magnetic
Resonance imaging,
Ultrasound, Nuclear
Medicine and other
DICOM compliant
modalities. The REGIUS
Unitea must not be used
for primary image
diagnosis in
mammography.X-ray Computed
Tomography, Magnetic
Resonance imaging,
Ultrasound, Nuclear
Medicine and other
DICOM compliant
modalities. The CO pilot
must not be used for
primary image diagnosis
in mammography.
Operating SystemMicrosoft Windows 10Microsoft Windows XPMicrosoft Windows 7
Importable
images
CR images
(REGIUS110/190/Σ1/Σ2
/210/110HQ)
DR Images (AeroDR
System, AeroDR
System2, SKR3000,
SKR4000)
● DICOM Images (CT,
MRI, US, etc.)
Generic format images●CR images
(REGIUS110/190/110H
Q)
●DICOM (CT, MRI, US,
etc.)
●Generic format images
CR images
(REGIUS110/190/Σ1/Σ2
/210/110HQ)
●DR Images (AeroDR
System)
●DICOM Images (CT,
MRI, US, etc.)
Generic format images
Image Processing●Automatic tone
adjustment
●Sharpness processing
●Equalization processing
●Noise suppression
function
●Automatic customize
function
●Initial display
optimization
processing (DR only)
●Grid Suppression
●Masking
●Re-sampling and
Resizing
●Stitching
Bone suppression
function●Automatic tone
adjustment
●Sharpness processing
●Equalization processing
●Noise suppression
function
●Automatic customize
function
●Grid Suppression
●Masking
●Re-sampling and
●Resizing
●Stitching●Automatic tone
adjustment
●Sharpness processing
●Equalization processing
●Noise suppression
function
●Automatic customize
function
●Initial display
optimization
processing (DR only)
●Grid Suppression
●Masking
●Re-sampling and
●Resizing
●Stitching

The comparison to the predicate decides was summarized in the table blow.

5

Image /page/5/Picture/0 description: The image shows the Konica Minolta logo. The logo consists of a blue globe-like shape with horizontal white lines across it. Below the globe is the text "KONICA MINOLTA" in a bold, sans-serif font.

Technological Characteristics

The subject and predicate devices use the same fundamental scientific technology to perform their intended use. Those modifications are for software modifications to the identified predicate device to update the Windows 10. In addition, the Bone Suppression

  • Page 3 of 4 -

Giving Shape to Ideas

6

Image /page/6/Picture/0 description: The image shows the logo for Konica Minolta. The logo consists of 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.

function cleared by via the KONICAMINOLTA Di-X1 (K182431) is incorporated into the subject device. The subject device also adds the cleared Konica Digital Radiography Systems (AeroDR System2, SKR 3000, and SKR 4000).

These differences were found to not affect safety or effectiveness via design verification activities.

Performance Data

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

Conclusion

The modifications raised no new issues of safety or effectiveness as compared to its legally marketed predicate devices. Performance tests demonstrate that the ImagePilot performs according to specifications and functions as intended. Therefore, the ImagePilot is substantially equivalent to its predicate devices (K071436 and K133730).