(176 days)
No
The document describes standard digital radiography image processing techniques and hardware modifications. There is no mention of AI or ML algorithms being used for image analysis, diagnosis, or any other function. The "Intelligent-Grid" is a grid removal process, not an AI/ML feature.
No
The device is used for diagnostic imaging (generating radiographic images), not for treating a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended to replace a radiographic film/screen system in general-purpose diagnostic procedures," and the "Device Description" mentions that the acquired image is transmitted as "diagnostic image data."
No
The device description explicitly mentions hardware components like an X-ray planar detector (FPDs P-65, P-75, etc.), a console (CS-7), and peripherals, which are integral to the device's function of generating and processing radiographic images. While software (Console CS-7) is a key component, the device is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "generating radiographic images of human anatomy" and is a "replace radiographic film/screen system in general-purpose diagnostic procedures." This describes an imaging device used on the patient, not a device used to test samples from the patient (which is the definition of an IVD).
- Device Description: The description details how the device captures X-ray images of the human body using a detector and processes those images. This aligns with the function of a medical imaging device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
The device is a digital radiography system, which is a type of medical imaging device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MQB, LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy
Indicated Patient Age Range
The device is used for carrying out exposures on children.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 Fukui
Senior Manager of Regulatory & QMS Division
1 Sakura-machi, Hino-shi, 191-8511 Japan
Telephone: +81 42 589 8429
Email: 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 892.1680
Regulation Name: Stationary x-ray system
Regulatory Class: Class II
Product Codes: MQB, LLZ | | |
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.
-
Page 1 of 5 -
4
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 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.
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.
- Page 2 of 5 -
5
Image /page/5/Picture/0 description: The image contains the logo for Konica Minolta. The logo features a blue circle at the top with several horizontal white lines running across it. Below the circle, the words "KONICA MINOLTA" are written in a bold, sans-serif font.
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 in | |
| generating radiographic images of | ||
| human anatomy. It is intended to replace | ||
| radiographic film/screen | ||
| system in general-purpose diagnostic | ||
| procedures. | ||
| This device is not indicated for use in | ||
| mammography, fluoroscopy, and | ||
| angiography applications. | 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. | ||
| Specification | ||
| Detection method | ||
| Scintillator | ||
| Image area size | Indirect conversion method | |
| Csl (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 method | |
| Csl (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 conversion | ||
| MTF(1.0 cycle/mm) | ||
| DQE (1.0 cycle/mm) | ||
| DQE (0 cycle/mm) | 16 bit (65,536 gradients) | |
| (Non-binning) 0.62 | ||
| (2x2 binning) 0.58 | ||
| 56% @ 1mR | ||
| 65% @ 0.02mR | 16 bit (65,536 gradients) | |
| (Non-binning) 0.62 | ||
| (2x2 binning) 0.58 | ||
| 56% @ 1mR | ||
| 65% @ 0.02mR | ||
| Mechanical | ||
| External dimensions | ||
| IPX | P-65: 384(W)×460(D)×15(H)mm | |
| P-75: 460(W)×460(D)×15(H)mm | ||
| IPX6 | P-61: 384(W)×460(D)×15(H)mm | |
| P-71: 460(W)×460(D)×15(H)mm | ||
| P-81: 282(W)×333(D)×15(H)mm | ||
| IPX6 | ||
| Battery | ||
| (Lithium-ion capacitor) | ||
| Battery duration in | ||
| standby status | P-65: Approx. 13.2 hours | |
| P-75: Approx. 12.2 hours | P-61: Approx. 13.2 hours | |
| P-71: Approx. 12.2 hours | ||
| P-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/minor | ||
| components | AeroDR Interface Units, Detector | |
| Interface Units, Power Supply Unit, | ||
| Generator Interface Units, Battery | ||
| Charger, etc. | AeroDR Interface Units, Detector | |
| Interface Units, Power Supply Unit, | ||
| Generator Interface Units, Battery | ||
| Charger, etc. | ||
| Operator console | ||
| (Software) | CS-7 |
- Software module modification to use
new FPDs (Cassette Type Detection
Software (CTDS)) - Software module modification to
support 40 seconds serial radiography
(SIC) | CS-7 |
| Image Processing | Auto-gradation process
Frequency processing (F process)
Equalization processing (E process)
Hybrid processing (HF process - HE
process)
Hybrid smoothing process (HS process)
REALISM processing (RE process - RF
process)
Realism smoothing process (RS
process)
Grid removal process/Scattered
Radiation Correction (Intelligent-Grid)
Automatic exposure field recognition
process | Auto-gradation process
Frequency processing (F process)
Equalization processing (E process)
Hybrid processing (HF process - HE
process)
Hybrid smoothing process (HS process)
REALISM processing (RE process - RF
process)
Realism smoothing process (RS
process)
Grid removal process/Scattered
Radiation Correction (Intelligent-Grid)
Automatic exposure field recognition
process |
| Serial radiography | Max. acquisition time: 40 seconds | Max. acquisition time: 20 seconds |
— Page 3 of 5 ————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
6
Image /page/6/Picture/0 description: The image contains the logo for Konica Minolta. The logo features a blue globe-like shape with horizontal white lines running across it. Below the graphic is the text "KONICA MINOLTA" in a bold, sans-serif font.
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.
Page 4 of 5
7
Image /page/7/Picture/0 description: The image contains the Konica Minolta logo. The logo features a blue globe-like shape with several horizontal white lines running across it. Below the globe, the words "KONICA MINOLTA" are written in a bold, sans-serif font.
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.
Page 5 of 5 -