This device is indicated for use in generating radiographic images of human anatomy. It is intended to a replace radiographic film/screen system in general-purpose diagnostic procedures.

This device is not indicated for use in mammography, fluoroscopy, and angiography applications.

Device Description

The digital radiography SKR 3000 performs X-ray imaging of the human body using an Xray planar detector that outputs a digital signal, which is then input into an image processing device, and the acquired image is then transmitted to a filing system, printer, and image display device as diagnostic image data.

The subject device SKR3000 is not intended for use in mammography
This device is also used for carrying out exposures on children.

The Console CS-7, which controls the receiving, processing, and output of image data, is required for operation. CS-7 implements the following image processing; gradation processing, frequency processing, dynamic range compression, smoothing, rotation, reversing, zooming, and grid removal process/scattered radiation - correction (Intelligent-Grid). The Intelligent-Grid is cleared in K151465.

The proposed SKR 3000 is modified to consist of new FPD P-65 and P-75 in addition to previously cleared P-61, P-71, and P-81, Console CS-7 and other peripherals. The DR Detector uses the exposure signal or exposure from the X-ray device to generate X-ray digital image data for diagnosis, including serial exposure images, and send to the image processing controller.

The operator console software, Console CS-7, is a software program for installation on a OTC PC. Software module modifications have been made to use new FPDs (P-65 and P-75) (Cassette Type Detection Software (CTDS)) and to support 40 seconds serial radiography (SIC).

The FPDs used in SKR 3000 can communicate with the image processing device through the wired Ethernet and/or the Wireless LAN (IEEE802.11a/n and FCC compliant). The WPA2-PSK (AES) encryption is adopted for a security of wireless connection.

The new DR panels, P-65 and P-75, employ the surface material containing antibacterial agent in both radiation and irradiation sides. In the serial radiography settings, acquisition time has been changed from up to 20 seconds to 40 seconds to observe a variety of dynamic objects. Other control parameters of serial radiography are not changed from the predicate device.

The SKR 3000 is distributed under a commercial name AeroDR 3.

AI/ML Overview

This document describes the Konica Minolta SKR 3000, a digital radiography system, and its substantial equivalence to a predicate device. The information provided focuses on the device's design, specifications, and performance testing to demonstrate compliance with standards, but does not include a detailed study proving the device meets specific acceptance criteria related to diagnostic accuracy or clinical outcomes through a prospective trial involving human readers. The provided text primarily focuses on engineering and regulatory compliance, not clinical performance metrics in the context of AI assistance or human reader improvement.

However, based on the provided text, here's a breakdown of the acceptance criteria met through performance testing as described, and the absence of certain study types:

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly states that "the performance tests according to the 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices' and the other verification and validation including the items required by the risk analysis for the SKR3000 were performed and the results demonstrated that the predetermined acceptance criteria were met."

While specific numerical acceptance criteria and their corresponding reported device performance values are not explicitly detailed in the text, the comparison table implicitly highlights characteristics where performance is expected to be equivalent or improved. For instance, the Signal-to-Noise Ratio (SNR) and Detective Quantum Efficiency (DQE) are critical performance metrics for X-ray detectors, and based on the equivalence asserted, one can infer that these metrics met predefined acceptance thresholds.

Given the information in the "Comparison Table", the following can be inferred as performance aspects that were evaluated and met criteria for substantial equivalence:

Acceptance Criteria (Implied from comparison)	Reported Device Performance (Implied from comparison)
Image Quality Metrics:
MTF (1.0 cycle/mm)	Non-binning: 0.62
MTF (1.0 cycle/mm)	2x2 binning: 0.58
DQE (1.0 cycle/mm)	56% @ 1mR
DQE (0 cycle/mm)	65% @ 0.02mR
Exposure Acquisition Time	Max. acquisition time: 40 seconds (for serial radiography)
Battery Duration in Standby	P-65: Approx. 13.2 hours; P-75: Approx. 12.2 hours
Antibacterial Properties	Surface infused with Silver ions (antibacterial properties)
Environmental Protection (IPX)	IPX6
Regulatory Compliance	AAMI/ANSI ES 60601-1 (Ed.3.1), IEC 60601-1-2 (Ed.4.0), and ISO 10993-1 (2018) met.
Software Functionality	New FPD support (CTDS) and 40 seconds serial radiography support (SIC) operating as intended.
Absence of New Safety/Effectiveness Issues	Performance tests demonstrated no new issues compared to predicate device.

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

The provided document does not detail any clinical test set or data provenance in terms of patient images or specific study populations. The performance data mentioned refers to engineering and quality assurance tests, not clinical performance studies with patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable or disclosed in the provided text. The document refers to engineering performance tests and compliance with regulatory standards, not expert-adjudicated clinical ground truth.

4. Adjudication Method for the Test Set

This information is not applicable or disclosed as there is no mention of a human-reviewed test set or adjudication process for diagnostic performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the provided text. The document indicates that "the results of risk management did not require clinical studies to demonstrate the substantial equivalency of the proposed device," which suggests that comparative effectiveness with human readers or AI assistance was not a component of this 510(k) submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

The device itself is a digital radiography system, which generates images. While there are software components (like Console CS-7 for image processing), the submission focuses on the hardware (FPDs) and overall system performance in generating X-ray images, not an AI algorithm's standalone diagnostic performance. Therefore, such a standalone diagnostic algorithm study is not mentioned. The "performance tests" refer to technical specifications and safety, not diagnostic accuracy.

7. The Type of Ground Truth Used

Based on the document, the "ground truth" for the acceptance criteria was primarily based on technical specifications, regulatory standards, and engineering performance requirements. These include metrics like MTF, DQE, mechanical dimensions, battery life, IPX ratings, and compliance with electrical safety and electromagnetic compatibility standards. No clinical ground truth (e.g., pathology, outcomes data, or expert consensus on disease presence) is mentioned as being used for performance evaluation in this submission.

8. The Sample Size for the Training Set

This is not applicable or disclosed. The document does not describe the development or training of an AI algorithm in the context of machine learning, so there is no mention of a training set of images.

9. How the Ground Truth for the Training Set Was Established

This is not applicable or disclosed as there is no mention of an AI training set.

Summary

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August 24, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Konica Minolta, Inc. % Mr. Jan Maniscalco QA Manager Konica Minolta Healthcare Americas, Inc. 2217 US Highway 70 E GARNER NC 27529

Re: K210619

Trade/Device Name: SKR 3000 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB, LLZ Dated: July 16, 2021 Received: July 20, 2021

Dear Mr. 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 (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) K210619

Device Name SKR 3000

Indications for Use (Describe)

This device is indicated for use in generating radiographic images of human anatomy. It is intended to a replace radiographic film/screen system in general-purpose diagnostic procedures.

This device is not indicated for use in mammography, fluoroscopy, and angiography applications.

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 features 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.

510(k) Summary K210619

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:	August 23, 2021
Device Name:	SKR 3000
Common Name:	Digital Radiography
Regulation Number:	21 CFR 892.1680
Regulation Name:	Stationary x-ray system
Regulatory Class:	Class II
Product Code(s):	MQB, LLZ
Predicate Device:	K182688 - SKR 3000 (KONICA MINOLTA, INC.)Regulation Number: 21 CFR 892.1680Regulation Name: Stationary x-ray systemRegulatory Class: Class IIProduct Codes: MQB, LLZ

Device Description

The subject device SKR3000 is not intended for use in mammography
This device is also used for carrying out exposures on children.
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Image /page/4/Picture/0 description: The image contains the Konica Minolta logo. The logo features a blue circle with several horizontal white lines running across it. Below the circle, the words "KONICA MINOLTA" are written in a bold, sans-serif font.

The SKR 3000 is distributed under a commercial name AeroDR 3.

Indications for Use

This device is indicated for use in generating radiographic images of human anatomy. It is intended to a replace radiographic film/screen system in general-purpose diagnostic procedures.

This device is not indicated for use in mammography, fluoroscopy, and angiography applications.

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Comparison Table

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

	Subject Device	Predicate Device
Device Name	SKR 3000	SKR 3000
510(K) Number	K210619	K182688
Indications for Use	This device is indicated for use ingenerating radiographic images ofhuman anatomy. It is intended to replaceradiographic film/screensystem in general-purpose diagnosticprocedures.This device is not indicated for use inmammography, fluoroscopy, andangiography applications.	The SKR 3000 is indicated for use ingenerating radiographic images ofhuman anatomy. It is intended toreplace radiographic film/screensystem in general-purpose diagnosticprocedures.The SKR 3000 is not indicated for usein mammography, fluoroscopy andangiography applications.
SpecificationDetection methodScintillatorImage area size	Indirect conversion methodCsl (Cesium Iodide)P-65: 348.8×425.6mm(3,488×4,256 pixels)P-75: 424.8×424.8mm(4,248×4,248 pixels)	Indirect conversion methodCsl (Cesium Iodide)P-61: 348.8×425.6mm(3,488×4,256 pixels)P-71: 424.8×424.8mm(4,248×4,248 pixels)P-81: 245.6×296.8mm(2,456×2,968 pixels)
Pixel size	100 µm / 200 µm / 400 µm	100 µm / 200 µm / 400 µm
A/D conversionMTF(1.0 cycle/mm)DQE (1.0 cycle/mm)DQE (0 cycle/mm)	16 bit (65,536 gradients)(Non-binning) 0.62(2x2 binning) 0.5856% @ 1mR65% @ 0.02mR	16 bit (65,536 gradients)(Non-binning) 0.62(2x2 binning) 0.5856% @ 1mR65% @ 0.02mR
MechanicalExternal dimensionsIPX	P-65: 384(W)×460(D)×15(H)mmP-75: 460(W)×460(D)×15(H)mmIPX6	P-61: 384(W)×460(D)×15(H)mmP-71: 460(W)×460(D)×15(H)mmP-81: 282(W)×333(D)×15(H)mmIPX6
Battery(Lithium-ion capacitor)Battery duration instandby status	P-65: Approx. 13.2 hoursP-75: Approx. 12.2 hours	P-61: Approx. 13.2 hoursP-71: Approx. 12.2 hoursP-81: Approx. 6.3 hours
Surface Material	Surface infused with Silver ions(antibacterial properties)	No antibacterial agent
	Subject Device	Predicate Device
Communication I/F	Wired and Wireless	Wired and Wireless
Peripherals,Cables/minorcomponents	AeroDR Interface Units, DetectorInterface Units, Power Supply Unit,Generator Interface Units, BatteryCharger, etc.	AeroDR Interface Units, DetectorInterface Units, Power Supply Unit,Generator Interface Units, BatteryCharger, etc.
Operator console(Software)	CS-7- Software module modification to usenew FPDs (Cassette Type DetectionSoftware (CTDS))- Software module modification tosupport 40 seconds serial radiography(SIC)	CS-7
Image Processing	Auto-gradation processFrequency processing (F process)Equalization processing (E process)Hybrid processing (HF process - HEprocess)Hybrid smoothing process (HS process)REALISM processing (RE process - RFprocess)Realism smoothing process (RSprocess)Grid removal process/ScatteredRadiation Correction (Intelligent-Grid)Automatic exposure field recognitionprocess	Auto-gradation processFrequency processing (F process)Equalization processing (E process)Hybrid processing (HF process - HEprocess)Hybrid smoothing process (HS process)REALISM processing (RE process - RFprocess)Realism smoothing process (RSprocess)Grid removal process/ScatteredRadiation Correction (Intelligent-Grid)Automatic exposure field recognitionprocess
Serial radiography	Max. acquisition time: 40 seconds	Max. acquisition time: 20 seconds

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Performance Data

The SKR 3000 is designed to comply with the following standards; AAMI/ANSI ES 60601-1 (Ed.3.1), IEC 60601-1-2 (Ed.4.0), and ISO 10993-1 (2018). The performance tests according to the "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" and the other verification and validation including the items required by the risk analysis for the SKR3000 were performed and the results demonstrated that the predetermined acceptance criteria were met. The results of risk management did not require clinical studies to demonstrate the substantial equivalency of the proposed device.

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Conclusion

The SKR 3000 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 (K182688). Performance tests demonstrate that the SKR 3000 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 SKR 3000 is substantially equivalent to the predicate devices and presents no new questions of safety or effectiveness.

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Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.