The SKR 3000 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen system in general-purpose diagnostic procedures.

The SKR 3000 is not indicated for use in mammography, tomography and angiography applications.

Device Description

The proposed SKR 3000 is modified to consist of new FPD P-71 and P-81 in addition to previously cleared P-61, Console CS-7 and other peripherals. Additionally, a radiography sequence of AeroSync, non tethered operation mode, is modified to incorporate improved usage that allow user to use a FPD without console CS-7. A user can capture the images and store them in FPD memories until when those readout images are transferred to the console CS-7 by a user.

The system is intended for use replacing a radiographic film/screen system in general-purpose diagnostic procedures of human anatomy. The system can be used in conjunction with current cleared AeroDR FPDs. The P-61, P-71, P-81 and the other compatible FPDs availably used in SKR 3000 are lightweight, mobile FPD and they are formed in compatible size with the cassette of ISO standard size.

The SKR 3000 performs radiography imaging of the human body using an X-ray planar detector (FPD) that outputs a digital signal, which is then input into an image processing device. The acquired image is transmitted to a filing system, printer, and image display device as diagnostic image after applying image processing to the raw data of image by the image processing device, Console CS-7.

The radiography sequences to be synchronized with a trigger timing of Xray irradiation are the same as the way of predicate device that requires the SRM / S-SRM connection between the SKR 3000 and X-ray generator. The AeroSync allows to use a FPD without a wired connection of SRM / S-SRM, the FPD itself begins to acquire an image when it detects X-ray irradiation in this mode. The compatible X-ray system is same as that of previously cleared SKR 3000.

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 SKR 3000 is designed to comply with the following standards; AAMI/ANSI ES 60601-1 (Ed.3.1), IEC 60601-1-2, and ISO 10993-1.

AI/ML Overview

Based on the provided text, the device in question, the KONICA MINOLTA SKR 3000, is an X-ray imaging system, and the submission is for a modification to an already cleared predicate device (K162504 The original SKR 3000) by adding new Flat Panel Detectors (FPDs) (P-71 and P-81) and a modified radiography sequence (AeroSync).

The crucial point from the document is:
"The concurrence study is not necessary according to the new SSXI Guidance because the proposed P-71 / P-81 have same imaging performance but overall change in the dimensions only. Besides, the results of risk management did not require clinical studies to demonstrate the substantial equivalency of the proposed device."

This statement indicates that the regulatory body determined that a full-fledged clinical study or comparative effectiveness study was NOT required because the new FPDs primarily change in physical dimensions while maintaining the same imaging performance as the already cleared predicate device. Therefore, many of the typical acceptance criteria and study aspects you'd expect for a novel AI or diagnostic device are not detailed in this 510(k) summary because they were not deemed necessary for this specific submission.

However, I can extract information relevant to the general performance testing and the implicit criteria used for this type of device based on what is stated:

Acceptance Criteria and Device Performance (Implicit/Inferred from the document's context)

For this specific 510(k) submission regarding the modification of the SKR 3000, the primary acceptance criteria revolved around demonstrating that the new components (P-71 and P-81 FPDs and the AeroSync modification) do not degrade the established performance of the predicate device and comply with relevant safety standards. The document explicitly states that the new FPDs have the "same imaging performance" as the predicate.

Acceptance Criteria (Inferred from regulatory context for X-ray systems)	Reported Device Performance (as stated or implied)
Imaging Performance Equivalence	"P-71 / P-81 have same imaging performance" as predicate P-61.
(e.g., Spatial Resolution, Contrast Resolution, Dose efficiency, DQE, MTF)	(Specific metrics not provided, but equivalence asserted)
Safety and Electrical Compliance	"The system is in conformance with the standards described above [AAMI/ANSI ES 60601-1 (Ed.3.1), IEC 60601-1-2]" and "same standards to those of predicate device."
Biocompatibility	"All patient contact materials... are identical to those of predicate device, and are evaluated under ISO 10993-1 and determined as acceptable."
Mechanical Integrity/Durability	Explicitly stated "overall change in the dimensions" for P-71 and P-81, implies new mechanical properties were evaluated. (No specific performance data given, but assumed within "performance tests")
Functional Equivalence (AeroSync)	"The system including a modified radiography sequence has same operational principles and designing as those of the predicate device." "Allows user to use a FPD without console CS-7" (new feature with stated functionality).

Study Details (as per the provided text for this specific 510(k) modification)

Sample sizes used for the test set and the data provenance:
- The document mentions "Performance tests" were performed "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."
- No specific sample sizes (e.g., number of images, patients) for the test set are mentioned. This is typical for submissions focused on hardware modifications retaining "imaging performance" rather than proving a new diagnostic capability. The tests would likely involve phantom images and bench testing rather than patient data in large quantities.
- Data provenance is not specified. Given the nature of the tests (bench/phantom), patient data provenance (country, retrospective/prospective) is likely irrelevant for this specific submission, as it's not a clinical performance study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not specified. Since this is primarily a hardware/engineering performance and safety validation (demonstrating equivalence to a predicate system rather than a new diagnostic claim), there is no mention of human experts establishing "ground truth" for diagnostic purposes. The ground truth for engineering tests typically comes from calibrated measurement equipment and reference standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / None specified. No adjudication method is mentioned as there's no diagnostic ground truth established by human readers for comparative or standalone performance in this context.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was explicitly NOT done. The document states: "The concurrence study is not necessary according to the new SSXI Guidance because the proposed P-71 / P-81 have same imaging performance but overall change in the dimensions only." This device is a digital radiography system, not an AI-based diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of an "algorithm." This device is an X-ray imaging system. The performance tests would be "standalone" in the sense that the device itself is tested for its physical and imaging characteristics (e.g., MTF, DQE, spatial resolution) using phantoms and test procedures, without a human in a diagnostic loop.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering/Physical Ground Truth: The "ground truth" for the performance tests would be based on calibrated measurements against established standards for X-ray imaging performance (e.g., physical properties of test phantoms, known radiation doses, measurements of image quality metrics like spatial resolution and contrast-to-noise ratio). It is not expert consensus, pathology, or outcomes data related to disease diagnosis.
The sample size for the training set:
- Not applicable / Not mentioned. This device is a traditional X-ray imaging system, not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established:
- Not applicable. As no training set is mentioned, no ground truth establishment for it is relevant.

Summary of Key Takeaways from the Document:

This 510(k) is for a modification to an existing X-ray system (SKR 3000), primarily introducing new FPDs with different physical dimensions but "same imaging performance."
Due to the nature of the modification (maintaining imaging performance and primarily changing dimensions), full clinical studies or comparative effectiveness studies (like MRMC) were explicitly deemed unnecessary by the FDA for this submission.
The "performance tests" focused on ensuring the new components met engineering and safety standards and maintained equivalence to the predicate device's established imaging performance.
"Ground truth" in this context refers to physical measurements and adherence to technical specifications rather than medical diagnostic outcomes or expert consensus on clinical cases.

Summary

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October 12, 2017

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 USA seal. 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. % Mr. Russell D. Munves Official Correspondent STORCH AMINI PC 140 East 45th Street, 25th Floor New York, New York 10017

Re: K172793

Trade/Device Name: SKR 3000 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MOB, LLZ Dated: September 14, 2017 Received: September 15, 2017

Dear Mr. Munves:

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. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K172793

Device Name SKR 3000

Indications for Use (Describe)

The SKR 3000 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen system in general-purpose diagnostic procedures.

The SKR 3000 is not indicated for use in mammography, tomography 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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510(k) Summary

Submitter's Name:	KONICA MINOLTA, INC.
Address:	1 Sakura-machi,Hino-shi, 191-8511 Japan
Contact:	Tsutomu Fukui
Telephone:	+81 42 589 8429
Date:	September 14, 2017
Trade Name:	SKR 3000
Model No:	P-61, P-71, P-81
Common Name:	Digital Radiography
Regulation Name / Number:	Stationary x-ray system / 21 CFR 892.1680
Regulatory Class:	Class II
Product Code(s):	90-MQB, 90-LLZ
Predicate Device(s):	K162504 - SKR 3000 (KONICA MINOLTA, INC.)Regulation Name: Stationary x-ray system (21CFR 892.1680),Product Codes: 90-MQB, 90-LLZ

Device Description:

The proposed SKR 3000 is modified to consist of new FPD P-71 and P-81
in addition to previously cleared P-61, Console CS-7 and other peripherals.
Additionally, a radiography sequence of AeroSync, non tethered
operation mode, is modified to incorporate improved usage that allow
user to use a FPD without console CS-7. A user can capture the images
and store them in FPD memories until when those readout images are
transferred to the console CS-7 by a user.

The system is intended for use replacing a radiographic film/screen
system in general-purpose diagnostic procedures of human anatomy.
The system can be used in conjunction with current cleared AeroDR FPDs.
The P-61, P-71, P-81 and the other compatible FPDs availably used in SKR
3000 are lightweight, mobile FPD and they are formed in compatible size
with the cassette of ISO standard size.

Page 1 of 4

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The SKR 3000 is designed to comply with the following standards; AAMI/ANSI ES 60601-1 (Ed.3.1), IEC 60601-1-2, and ISO 10993-1.

Indications for Use:

The SKR 3000 is indicated for use in generating radiographic images of human anatomy. It is intended to replace a radiographic film/screen system in general-purpose diagnostic procedures. The SKR 3000 is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.

Predicate Comparison Table:

	KONICA MINOLTA	KONICA MINOLTA
	SKR 3000	SKR 3000
510(K) Control Number	Proposed device	K162504
Indications for Use	Same as Predicate device
Specification
Detection method	Same as Predicate device	Indirect conversion method
Scintillator	Same as Predicate device	Csl (Cesium Iodide)

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	KONICA MINOLTASKR 3000	KONICA MINOLTASKR 3000
510(K) Control Number	Proposed device	K162504
Image area size	P-71: 424.8×424.8mm(4,248×4,248 pixels)	P-61: 348.8×425.6mm(3,488×4,256 pixels)
	P-81: 245.6×296.8mm(2,456×2,968 pixels)
Pixel size μ	Same as Predicate device	100 μm / 200 μm
A/D conversion	Same as Predicate device	16 bit (65,536 gradients)
Mechanical
External dimensions	P-71: 460(W)×460(D)×15(H)mmP-81: 282(W)×333(D)×15(H)mm	P-61: 384(W)×460(D)×15(H)mm
IPX	Same as Predicate device	IPX6
Communication I/F	Same as Predicate device
Operator console	Same as Predicate device
Compatible X-ray system Spec.	Same as Predicate device

Summary of Technological Characteristics

Compared to Predicate Device:

The modified SKR 3000 employs additional FPDs of P-71 and P-81 which are overall change in the dimensions of the image receptor with otherwise identical materials of predicate P-61. The system has same scientific technologies as the predicate device (K162504). The indications for use are not modified, and the other summary of comparisons of technological characteristics for both systems is provided below;

Operational principles and designing:

The system including a modified radiography sequence has same operational principles and designing as those of the predicate device. The proposed P-71 / P-81 employ same scintillator and provide same imaging performance as those of the predicate P-61. The same peripheral components provide same function of the component of the predicate device, and complies with same EMC and electrical safety standards. The proposed device is essentially the same as previously cleared predicate device from technology view point.

Performance test:

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

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and validation including the items required by the risk analysis for the SKR 3000 were performed and the results demonstrated that the predetermined acceptance criteria were met.

The concurrence study is not necessary according to the new SSXI Guidance because the proposed P-71 / P-81 have same imaging performance but overall change in the dimensions only. Besides, the results of risk management did not require clinical studies to demonstrate the substantial equivalency of the proposed device.

Safety:

The system is in conformance with the standards described above, which are same standards to those of predicate device.

Biocompatibility:

The all patient contact materials for human body surface are identical to those of predicate device, and are evaluated under ISO 10993-1 and determined as acceptable for this usage. The proposed P-71 / P-81 and the predicate P-61 have achieved same acceptance level for biocompatibility.

Conclusion:

The clinical study as a performance testing is not required to support substantial equivalence for the proposed device. In addition, as discussed in the above technological comparison, the technological characteristics of the SKR 3000 are deemed to be substantially equivalent to the predicate device that have already been cleared for USA distribution with 510(k) premarket notification number K162504.

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.