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.

AI/ML Overview

This document (K210066) is a 510(k) Summary for a medical image management and processing system called ImagePilot. It addresses the device's substantial equivalence to previously cleared predicate devices.

Crucially, this document states: "No clinical studies were required to support the substantial equivalence." This means the information requested regarding acceptance criteria, performance studies, sample sizes, expert ground truth, MRMC studies, and training data provenance is largely not applicable in the context of this 510(k) submission.

The acceptance criteria here are related to design verification activities and demonstrating that the device performs according to specifications and functions as intended based on internal testing. There is no large-scale clinical performance study described to prove the device meets specific performance criteria against a clinical ground truth.

However, I can extract information related to the device's technical characteristics and the basis for its clearance:

Summary of Acceptance Criteria and Study Information as Implied by the 510(k):

Given that "No clinical studies were required to support the substantial equivalence," the "acceptance criteria" and "study" are primarily focused on design verification and non-clinical performance testing to demonstrate that the updated software (ImagePilot v1.92) functions as intended and is equivalent to its predicates.

1. Table of Acceptance Criteria and Reported Device Performance:

Since no clinical study data is reported, the acceptance criteria are implicitly met by "design verification activities" and demonstration that the "ImagePilot performs according to specifications and functions as intended." No specific quantitative performance metrics against a clinical outcome are presented.

Acceptance Criteria (Implied)	Reported Device Performance
Device performs according to specifications.	"the results demonstrated that the predetermined acceptance criteria were met."
Device functions as intended.	"the ImagePilot performs according to specifications and functions as intended."
Modifications do not affect safety or effectiveness compared to predicates.	"These differences were found to not affect safety or effectiveness via design verification activities."
Compatibility with specified operating systems (Microsoft Windows 10).	Device is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications.
Ability to process and display images from specified modalities (Plain X-ray Radiography, CT, MRI, Ultrasound, Nuclear Medicine, other DICOM compliant).	Explicitly stated as a function of ImagePilot and compared as equivalent to predicates.
Ability to perform specified image processing functions (e.g., automatic tone adjustment, sharpness processing, noise suppression, bone suppression).	Explicitly stated as a function of ImagePilot and compared as equivalent to predicates.
Must not be used for primary image diagnosis in mammography.	Stated as a limitation in the Indications for Use.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not applicable. No clinical test set (i.e., patient data for clinical performance evaluation) was used for substantial equivalence. The "test set" would refer to internal software testing/design verification, for which details (like specific number of images or test cases) are not provided in this public summary.
Data Provenance: Not applicable for a clinical test set. The document does not specify the origin of any images used for internal testing/verification, if applicable. These would likely be internally generated or representative test images.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. Since no clinical studies were required, there was no need for expert-established ground truth in the context of clinical performance evaluation for this 510(k). The "ground truth" for the device's functionality would be established by its adherence to engineering specifications and software quality assurance.

4. Adjudication Method for the Test Set:

Not applicable. No clinical test set requiring adjudication was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document explicitly states, "No clinical studies were required to support the substantial equivalence."

6. Standalone (Algorithm Only) Performance:

This device is software that processes and presents medical images. Its "performance" in this context is primarily functional – correctly processing and displaying images as specified. It is not an AI algorithm designed to make a diagnostic determination independently. Its function is to facilitate image review by a human.
Therefore, performance is measured against its technical specifications, not typically as a standalone diagnostic algorithm.

7. Type of Ground Truth Used:

Not applicable for clinical performance. The "ground truth" for this submission refers to the internal specifications and functional requirements of the software, and verifying that the software meets these requirements through design verification and non-clinical performance testing.

8. Sample Size for the Training Set:

Not applicable. This device description does not indicate that it uses machine learning or an AI algorithm that requires a "training set" in the sense of a dataset for model development. Its function is image processing and presentation based on established algorithms, not learning from data.

9. How the Ground Truth for the Training Set was Established:

Not applicable. As above, there's no mention or implication of a training set for an AI/ML model for this device.

In conclusion, this 510(k) submission for ImagePilot v1.92 focused on demonstrating substantial equivalence through non-clinical performance testing and design verification, primarily to show that software modifications (e.g., OS update, incorporation of a previously cleared function) did not negatively impact the device's safety or effectiveness compared to its predicates. It does not contain information about clinical studies or AI model development and validation as would be found for a device leveraging advanced AI for diagnostic assistance.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K210066

Device Name ImagePilot

Indications for Use (Describe)

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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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 FukuiSenior Manager of Regulatory & QMS Division1 Sakura-machi, Hino-shi, 191-8511 JapanTelephone: +81 42 589 8429Email: 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 UniteaKONICA MINOLTA MEDICAL & GRAPHIC, INC.Regulation Number: 21 CFR 892.2050Product Codes: LLZ
Secondary Predicate Device:	K133730	CO Pilot/REGIUS UniteaKONICA MINOLTA, INC.Regulation Name: 21 CFR 892.2050Product 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

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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

Comparison Table
------------------	--

	Subject Device	Predicate Device 1 (PD1)	Predicate Device 2 (PD2)
	ImagePilot	REGIUS Unitea	CO Pilot/REGIUS Unitea
510(K) Number	K210066	K071436	K133730
Indications forUse	The ImagePilot softwareis intended for installationon an off-the-shelf PCmeeting or exceedingminimum specifications.The ImagePilot softwareprimarily facilitatesprocessing andpresentation of medicalimages on displaymonitors suitable for themedical task beingperformed. TheImagePilot software canprocess and displaymedical images from thefollowing modality types:Plain X-ray Radiography,	The REGIUS Uniteasoftware is intended forinstallation on an off-the-shelf PC meeting orexceeding minimumspecifications. TheREGIUS Unitea softwareprimarily facilitatesprocessing andpresentation of medicalimages on displaymonitors suitable for themedical task beingperformed. The REGIUSUnitea software canprocess and displaymedical images from thefollowing modality types:	The CO pilot is intendedfor installation on an off-the-shelf PC (REGIUSUnitea /510(K) number:K071436) meeting orexceeding minimumspecifications. The COpilot software primarilyfacilitates processing andpresentation of medicalimages on displaymonitors suitable for themedical task beingperformed. The CO pilotsoftware can process anddisplay images from thefollowing modality types:Plain X-ray Radiography,
	Subject Device	Predicate Device 1 (PD1)	Predicate Device 2 (PD2)
	ImagePilot	REGIUS Unitea	CO Pilot/REGIUS Unitea
510(K) Number	K210066	K071436	K133730
	X-ray ComputedTomography, MagneticResonance imaging,Ultrasound, NuclearMedicine and otherDICOM compliantmodalities. TheImagePilot must not beused for primary imagediagnosis inmammography.	Plain X-ray Radiography,X-ray ComputedTomography, MagneticResonance imaging,Ultrasound, NuclearMedicine and otherDICOM compliantmodalities. The REGIUSUnitea must not be usedfor primary imagediagnosis inmammography.	X-ray ComputedTomography, MagneticResonance imaging,Ultrasound, NuclearMedicine and otherDICOM compliantmodalities. The CO pilotmust not be used forprimary image diagnosisin mammography.
Operating System	Microsoft Windows 10	Microsoft Windows XP	Microsoft Windows 7
Importableimages	●CR images(REGIUS110/190/Σ1/Σ2/210/110HQ)●DR Images (AeroDRSystem, AeroDRSystem2, SKR3000,SKR4000)● DICOM Images (CT,MRI, US, etc.)●Generic format images	●CR images(REGIUS110/190/110HQ)●DICOM (CT, MRI, US,etc.)●Generic format images	●CR images(REGIUS110/190/Σ1/Σ2/210/110HQ)●DR Images (AeroDRSystem)●DICOM Images (CT,MRI, US, etc.)●Generic format images
Image Processing	●Automatic toneadjustment●Sharpness processing●Equalization processing●Noise suppressionfunction●Automatic customizefunction●Initial displayoptimizationprocessing (DR only)●Grid Suppression●Masking●Re-sampling andResizing●StitchingBone suppressionfunction	●Automatic toneadjustment●Sharpness processing●Equalization processing●Noise suppressionfunction●Automatic customizefunction●Grid Suppression●Masking●Re-sampling and●Resizing●Stitching	●Automatic toneadjustment●Sharpness processing●Equalization processing●Noise suppressionfunction●Automatic customizefunction●Initial displayoptimizationprocessing (DR only)●Grid Suppression●Masking●Re-sampling and●Resizing●Stitching

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

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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

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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).

Regulation Number and Section

§ 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).