SKR 3000

K223267 · Konica Minolta, Inc. · MQB · Nov 17, 2022 · Radiology

Device Facts

• Record ID: K223267
• Device Name: SKR 3000
• Applicant: Konica Minolta, Inc.
• Product Code: MQB · Radiology
• Decision Date: Nov 17, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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.

Device Story

SKR 3000 is a digital radiography system using X-ray planar detectors to capture human anatomy images. System inputs digital signals from detectors into Console CS-7 software for processing; outputs diagnostic images to filing systems, printers, or displays. Used in clinical settings for general-purpose diagnostics, including pediatric patients. Modifications introduce wireless serial radiography functionality using P-65/P-75 detectors. CS-7 software performs image processing (gradation, frequency, dynamic range compression, smoothing, rotation, zooming, grid removal/scattered radiation correction via Intelligent-Grid). Healthcare providers use processed images for diagnostic decision-making. Benefits include replacement of traditional film/screen systems with digital workflow.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated through bench testing, verification, and validation activities, including risk management analysis, confirming compliance with AAMI/ANSI ES 60601-1 and IEC 60601-1-2 standards.

Technological Characteristics

Stationary X-ray system; digital planar detectors (P-61, P-71, P-81, P-65, P-75, P-82, P-85, P-95). Connectivity: Wireless and wired. Software: Console CS-7 for image processing. Standards: AAMI/ANSI ES 60601-1 (Ed.3.1), IEC 60601-1-2 (Ed.4.0).

Indications for Use

Indicated for generating radiographic images of human anatomy in general-purpose diagnostic procedures. Includes pediatric patients. Not indicated for mammography, fluoroscopy, or angiography.

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

• SKR 3000 (K213908)

Reference Devices

• PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress (K221803)

Submission Summary (Full Text)

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November 17, 2022

Image /page/0/Picture/1 description: The image shows 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 consists of 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. % Jan Maniscalco Executive Vice President QA/RA Konica Minolta Healthcare Americas, Inc. 411 Newark Pompton Turnpike WAYNE NJ 07470

#### Re: K223267

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: October 24, 2022 Received: October 24, 2022

### 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 (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 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-regulatoryassistance/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,

Zhkke

Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological 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) K223267

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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|----------------------------------------------------------------------------------|
| <span></span> | |
| <span></span> | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
| <span></span> | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary K223267

| Company: | KONICA MINOLTA, INC. | |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | 1 Sakura-machi, Hino-shi, Tokyo, 191-8511, Japan | |
| Contact: | Tsutomu Fukui<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 04, 2022 | |
| 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: | K213908 - SKR 3000 (KONICA MINOLTA, INC.) | |
| | Regulation Number: 21 CFR 892.1680 | |
| | Regulation Name: Stationary x-ray system | |
| | Regulatory Class: Class II | |
| | Product Codes: MQB, LLZ | |
| Reference Device: | K221803 - PHOENIX/AeroDR TX m01 and<br>PHOENIX/mKDR Xpress (SEDECAL SA) | |
| | Regulation Number: 21 CFR 892.1720 | |
| | Regulation Name: Mobile x-ray system | |
| | Regulatory Class: Class II | |
| | Product Codes: IZI, MQB | |

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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 Moderate level of concern. 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 CS-7 modifications have been made for a wireless serial radiography.

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

This submission is to introduce a wireless serial radiography into the SKR 3000 system. The wireless serial radiography function of P-65 / P-75 used with Phoenix was cleared under K221803. These detectors are wireless and their serial radiography functions are not being controlled by the x-ray generator. Hence no detector integration testing is necessary.

# 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.

# Comparison Table

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

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| | Subject Device | Predicate Device |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | SKR 3000 | SKR 3000 |
| 510(K) Number | K223267 | K213908 |
| Indications for Use | This device is indicated for use in<br>generating radiographic images of<br>human anatomy. It is intended to replace 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. | This device is indicated for use in<br>generating radiographic images of<br>human anatomy. It is intended to replace 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. |
| DR Detector | P-61 (14" x 17")<br>P-71 (17" x 17")<br>P-81 (10" x 12")<br>P-65 (14" x 17")<br>P-75 (17" x 17")<br>P-82 (14" x 17")<br>P-85 (14" x 17")<br>P-95 (17" x 17") | P-61 (14" x 17")<br>P-71 (17" x 17")<br>P-81 (10" x 12")<br>P-65 (14" x 17")<br>P-75 (17" x 17")<br>P-82 (14" x 17")<br>P-85 (14" x 17")<br>P-95 (17" x 17") |
| Serial Radiography | Wired (P-61, P-71, P-65, P-75)<br>Wireless (P-65, P-75) | Wired (P-61, P-71, P-65, P-75) |
| Components or<br>Accessories | AeroDR Interface Units, Detector<br>Interface Units, Power Supply Unit,<br>Generator Interface Units, GIU SZ,<br>Battery Charger, etc. | AeroDR Interface Units, Detector<br>Interface Units, Power Supply Unit,<br>Generator Interface Units, Battery<br>Charger, etc. |
| Operator Console | CS-7 | CS-7 |
| Image Processing | Auto-gradation process<br>Frequency processing (F process)<br>Equalization processing (E process)<br>Hybrid processing (HF, HE, HS)<br>REALISM processing (RF, RE, RS)<br>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, HE, HS)<br>REALISM processing (RF, RE, RS)<br>Intelligent-Grid<br>Automatic exposure field recognition<br>process |

# Performance Data

The SKR 3000 is designed to comply with the following standard; AAMI/ANSI ES 60601-1 (Ed.3.1) and IEC 60601-1-2 (Ed.4.0). The verification 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 results of risk

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management did not require clinical studies to demonstrate the substantial equivalency of the subject device modifications.

# 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 (K213908). Performance tests demonstrate that the SKR 3000 performs according to specifications and functions as intended. It is concluded that the subject device is to be as safe and effective as the predicate and substantially equivalent to the predicate device.