SKR 3000

K241319 · Konica Minolta, Inc. · MQB · Nov 21, 2024 · Radiology

Device Facts

• Record ID: K241319
• Device Name: SKR 3000
• Applicant: Konica Minolta, Inc.
• Product Code: MQB · Radiology
• Decision Date: Nov 21, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The SKR 3000 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. The P-53 is for adult use only.

Device Story

Digital radiography system (AeroDR 3) captures X-ray images using P-53 flat-panel detector (FPD). FPD uses indirect conversion (CsI scintillator) to output digital signals. Console CS-7 software processes data via gradation, frequency, dynamic range compression, and Intelligent-Grid (scatter correction) algorithms. Output transmitted to display, printer, or filing system. Used in clinical settings by healthcare professionals. Wired/wireless (WPA2-PSK) connectivity. Benefits include improved image resolution and DQE compared to predicate; antibacterial silver-ion infused surface. Clinical decision-making supported by high-quality diagnostic images.

Clinical Evidence

Bench testing only. No clinical data provided. Performance validated via electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), software verification/validation, and comparative image testing per FDA guidance for solid-state X-ray imaging devices. Results met predetermined acceptance criteria.

Technological Characteristics

Indirect conversion FPD (P-53) with CsI scintillator and glass-based TFT substrate. 150 µm pixel size, 2.5 lp/mm resolution. Carbon surface with silver-ion antibacterial infusion. Wired/Wireless (IEEE 802.11a/n) connectivity with WPA2-PSK encryption. IP56 rated. Software-based image processing (CS-7).

Indications for Use

Indicated for generating radiographic images of human anatomy in general-purpose diagnostic procedures. Not for mammography, fluoroscopy, or angiography. P-53 detector is for adult use only.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• AeroDR System2 (K151465)

Reference Devices

• SKR 3000 (K210619)

Submission Summary (Full Text)

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November 21, 2024

Konica Minolta, Inc. % Jan Maniscalco Executive Vice President QA/RA Konica Minolta Healthcare Americas, Inc. 411 Newark Pompton Turnpike WAYNE, NJ 07470

Re: K241319

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: May 10, 2024 Received: May 10, 2024

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of 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) K241319

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, fluoroscopy and angiography applications. The P-53 is for adult use only.

Type of Use (Select one or both, as applicable)

| <span style="font-size:10pt"> <b> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </b> </span> |
|----------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size:10pt"> <b> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </b> </span> |

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# 510(k) Summary K241319

| Company: | KONICA MINOLTA, INC.<br>1 Sakura-machi, Hino-shi, Tokyo, 191-8511, Japan |
|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Makoto Sumi<br>Senior Manager of Regulatory & QMS Division<br>Quality Assurance Operations<br>Healthcare Business Headquarters<br>Telephone: [phone]<br>Email: [e-mail] |
| Date Prepared: | November 21, 2024 |
| Device Name:<br>Common Name:<br>Regulation Number:<br>Regulation Name:<br>Regulatory Class:<br>Product Code(s): | SKR 3000<br>Digital Radiography<br>21 CFR 892.1680<br>Stationary x-ray system<br>Class II<br>MQB, LLZ |
| Predicate Device: | K151465 - AeroDR System2 (KONICA MINOLTA, INC.)<br>Regulation Number: 21 CFR 892.1680<br>Regulation Name: Stationary x-ray system<br>Regulatory Class: Class II<br>Product Codes: MQB, LLZ |
| Reference Device: | K210619 - SKR 3000 (KONICA MINOLTA, INC.)<br>Regulation Number: 21 CFR 892.1680<br>Regulation Name: Stationary x-ray system<br>Regulatory Class: Class II<br>Product Codes: MQB, LLZ |

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Giving Shape to Ideas

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# 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.

- This device 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. The CS-7 is a software with basic documentation level. 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.

This submission is to add the new flat-panel x-ray detector (FPD) P-53 to the SKR 3000. The new P-53 panel shows improved performance compared to the predicate device. The P-53 employs the same surface material infused with Silver ions (antibacterial properties) as the reference device.

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 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.

The P-53 is for adult use only.

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Giving Shape to Ideas

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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 | AeroDR System2 |
| 510(K) Number | K241319 | K151465 |
| Indications for Use | This device is indicated for use in<br>generating radiographic images of<br>human anatomy. It is intended to a<br>replace radiographic film/screen<br>system in general-purpose diagnostic<br>procedures.<br>This device is not indicated for use in<br>mammography, fluoroscopy, and<br>angiography applications.<br>The P-53 is for adult use only. | The AeroDR SYSTEM 2 is indicated for<br>use in generating radiographic images<br>of human anatomy. It is intended to<br>replace radiographic film/screen<br>system in general-purpose diagnostic<br>procedures.<br>The AeroDR SYSTEM 2 is not indicated<br>for use in mammography, fluoroscopy,<br>tomography and angiography<br>applications. |
| Specification<br>Detection method<br>Scintillator<br>TFT sensor substrate<br>Image area size | P-53<br>Indirect conversion method<br>Csl (Cesium Iodide)<br>Glass-based TFT substrate<br>345.6×420.0mm<br>(2,304×2,800 pixels) | P-52<br>Indirect conversion method<br>Csl (Cesium Iodide)<br>Glass-based TFT substrate<br>348.95 ×425.25mm<br>(1,994×2,430 pixels) |
| Pixel size | 150 µm | 175 μm |
| A/D conversion | 16 bit (65,536 gradients) | 16 bit (65,536 gradients) |
| Max. Resolution | 2.5 lp/mm | 2.0 lp/mm |
| MTF(1.0 lp/mm) | 0.62 | 0.62 |
| DQE (1.0 lp/mm) | 40% @ 1mR | 35% @ 1mR |
| Mechanical<br>External dimensions | 384(W)×460(D)×15(H)mm | 383.7(W)×460.2(D)×15.9(H)mm |
| IP Code (IEC 60529) | IP56 | IPX5 |
| Battery<br>Type<br>Number of batteries<br>Battery duration in<br>standby status | Lithium-ion capacitor<br>One<br>Approx. 6.2 hours | Lithium-ion capacitor<br>One<br>Approx. 10 hours |
| Surface Material | Carbon Surface infused with Silver ions<br>(antibacterial properties) | Carbon Surface |
| | Subject Device | Predicate Device |
| Communication I/F | Wired and Wireless | Wired and Wireless |
| Peripherals,<br>Cables/minor<br>components | AeroDR Interface Units, Detector<br>Interface Units, Power Supply Unit,<br>Generator Interface Units, Battery<br>Charger, Cables etc. | AeroDR Interface Units, Generator<br>Interface Units, Battery Charger, Cables<br>etc. |
| Operator console<br>(Software) | CS-7<br>- SKR 3000/AeroDR3 interface for P-53<br>(CTDS) | CS-7<br>- SKR 3000/AeroDR3 interface for P-52<br>(CTDS) |
| Image Processing | Auto-gradation process<br>Frequency processing (F process)<br>Equalization processing (E process)<br>Hybrid processing (HF process - HE<br>process)<br>Hybrid smoothing process (HS process)<br>REALISM processing (RE process - RF<br>process)<br>REALISM smoothing process (RS<br>process)<br>Grid removal process/Scattered<br>Radiation Correction (Intelligent-Grid)<br>Automatic exposure field recognition<br>process | Auto-gradation process<br>Frequency processing (F process)<br>Equalization processing (E process)<br>Hybrid processing (HF process - HE<br>process)<br>Hybrid smoothing process (HS process)<br>Grid removal process/Scattered<br>Radiation Correction (Intelligent-Grid)<br>Automatic exposure field recognition<br>process |
| Serial radiography | Not applicable | Not applicable |

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The Indications for Use statement has been modified to exclude the P-53 from use in pediatric imaging. The software functionality remains unchanged from the recently cleared device (K223267).

# Performance Data

The following performance data were provided in support of the substantial equivalence determination.

#### Electrical safety and electromagnetic compatibility (EMC)

The system complies with the IEC 60601-1 for safety and the IEC 60601-1-2 standard for EMC.

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#### Software Verification and Validation Testing

Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions". The software for this device was considered as a "Basic" documentation level, since a failure or latent flaw in the software could not directly result in serious injury or death to the patient or operator.

### Cybersecurity Testing

Security testings were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions".

#### Performance Testing

The performance testing was conducted according to the "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices". The comparative image testing was conducted to demonstrate substantially equivalent image performance for the subject device. The other verification and validation including the items required by the risk analysis for the SKR 3000 were performed and the results showed that the predetermined acceptance criteria were met. The results of risk management did not require clinical studies to demonstrate the substantial equivalence of the proposed device.

## Conclusion

The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that the SKR 3000 should perform for its intended purpose of general imaging. The comparative image data demonstrate that the SKR 3000 shows improved image performance compared to the predicate device.

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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