(195 days)
No
The document describes standard image processing techniques and does not mention AI, ML, or related concepts.
No.
The device is used to generate radiographic images for diagnostic purposes, not for treating diseases or conditions.
Yes
The device is indicated for use in "general-purpose diagnostic procedures" and outputs "diagnostic image data."
No
The device description explicitly mentions hardware components like an "X-ray planar detector" and a "flat-panel x-ray detector (FPD) P-53". While it includes software (Console CS-7) for image processing, it is part of a larger hardware system for generating and processing X-ray images.
No, 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 "replace radiographic film/screen system in general-purpose diagnostic procedures." This describes an in-vivo imaging device, not a device used to examine specimens from the human body (which is the definition of an IVD).
- Device Description: The description details how the device performs "X-ray imaging of the human body" using an "Xray planar detector." This further confirms it's an imaging device that interacts directly with the patient.
- Input Imaging Modality: The input modality is "X-ray," which is used for imaging the inside of the body, not for analyzing samples.
IVD devices are used to examine specimens such as blood, urine, or tissue outside of the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
N/A
Intended Use / Indications for 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. The P-53 is for adult use only.
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 X-ray 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.
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 P-53 is for adult use only.
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)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Max. Resolution: 2.5 lp/mm
MTF(1.0 lp/mm): 0.62
DQE (1.0 lp/mm): 40% @ 1mR
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
Image /page/0/Picture/0 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 logo. 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.
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.
1
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
2
assistance/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,
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
3
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)
| 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."
4
Image /page/4/Picture/0 description: The image shows the Konica Minolta logo. The logo consists of a blue circle with several horizontal white lines running across the middle. Below the circle, the words "KONICA MINOLTA" are written in a bold, sans-serif font.
510(k) Summary K241319
| Company: | KONICA MINOLTA, INC.
1 Sakura-machi, Hino-shi, Tokyo, 191-8511, Japan |
|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Makoto Sumi
Senior Manager of Regulatory & QMS Division
Quality Assurance Operations
Healthcare Business Headquarters
Telephone: +81 42 589 8429
Email: makoto.sumi@konicaminolta.com |
| Date Prepared: | November 21, 2024 |
| Device Name:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code(s): | SKR 3000
Digital Radiography
21 CFR 892.1680
Stationary x-ray system
Class II
MQB, LLZ |
| Predicate Device: | K151465 - AeroDR System2 (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: | K210619 - 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 |
- Page 1 of 5 -
Giving Shape to Ideas
5
Image /page/5/Picture/0 description: The image shows the Konica Minolta logo. The logo consists of a blue circle with several horizontal white lines across the middle. Below the circle, the words "KONICA MINOLTA" are written in a bold, sans-serif font.
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.
- Page 2 of 5 -
Giving Shape to Ideas
6
Image /page/6/Picture/0 description: The image shows the Konica Minolta logo. The logo consists of a blue circle with several horizontal white lines running across the middle. 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 | AeroDR System2 |
| 510(K) Number | K241319 | K151465 |
| 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. | The AeroDR SYSTEM 2 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 AeroDR SYSTEM 2 is not indicated | ||
| for use in mammography, fluoroscopy, | ||
| tomography and angiography | ||
| applications. | ||
| Specification | ||
| Detection method | ||
| Scintillator | ||
| TFT sensor substrate | ||
| Image area size | P-53 | |
| Indirect conversion method | ||
| Csl (Cesium Iodide) | ||
| Glass-based TFT substrate | ||
| 345.6×420.0mm | ||
| (2,304×2,800 pixels) | P-52 | |
| Indirect conversion method | ||
| Csl (Cesium Iodide) | ||
| Glass-based TFT substrate | ||
| 348.95 ×425.25mm | ||
| (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 | ||
| 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 | ||
| Type | ||
| Number of batteries | ||
| Battery duration in | ||
| standby status | Lithium-ion capacitor | |
| One | ||
| Approx. 6.2 hours | Lithium-ion capacitor | |
| One | ||
| Approx. 10 hours | ||
| Surface Material | Carbon Surface infused with Silver ions | |
| (antibacterial properties) | Carbon Surface | |
| 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, Cables etc. | AeroDR Interface Units, Generator | |
| Interface Units, Battery Charger, Cables | ||
| etc. | ||
| Operator console | ||
| (Software) | CS-7 |
- SKR 3000/AeroDR3 interface for P-53
(CTDS) | CS-7 - SKR 3000/AeroDR3 interface for P-52
(CTDS) |
| 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)
Grid removal process/Scattered
Radiation Correction (Intelligent-Grid)
Automatic exposure field recognition
process |
| Serial radiography | Not applicable | Not applicable |
— Page 3 of 5 ————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
7
Image /page/7/Picture/0 description: The image shows the Konica Minolta logo. The logo consists of a blue sphere with several horizontal white lines across it. Below the sphere, the words "KONICA MINOLTA" are written in a bold, sans-serif font.
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.
- Page 4 of 5 -
8
Image /page/8/Picture/0 description: The image contains the logo for Konica Minolta. The logo features a blue circle with several horizontal white lines running across the middle. Below the circle, the words "KONICA MINOLTA" are written in a bold, sans-serif font.
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.
Page 5 of 5 -