(29 days)
No
The summary does not mention AI, ML, or any related terms, and the device description and intended use are typical of a standard digital radiography system.
No
The device is used for generating radiographic images for diagnostic purposes, not for treating any medical conditions.
Yes
The device is described as being used in "general-purpose diagnostic procedures" and for generating "radiographic images," which are key components of diagnostic processes in healthcare.
No
The device description explicitly states it includes a "digital radiography panel," which is a hardware component.
Based on the provided information, 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 replacing "radiographic film/screen system in general-purpose diagnostic procedures." This describes an imaging device used to visualize internal structures, not a device used to examine specimens (like blood, urine, or tissue) outside the body to diagnose diseases or conditions.
- Device Description: The description mentions a "digital x-ray system upgrade kit, including software and digital radiography panel." This aligns with an imaging system, not an IVD.
- Input Imaging Modality: The input is "X-ray," which is an imaging modality, not a method for analyzing biological samples.
- Anatomical Site: The focus is on "Human anatomy," indicating the device is used on the patient directly for imaging.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to create images of the body itself.
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
Konica Minolta Universal DR 1748 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography panel. The indications for use remains unchanged: 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. So the only difference between this submission and the predicate submission is the manufacturer of the digital panel and the supplied software is different Each system consists of the following items:
Customer supplies: Diagnostic x-ray generator (HF) Class I Code IZO. + Tubehead: Class I Code ITY + Tube Mount: Class I Code IYB + Attached Collimator, Manual (IZX) Class II 510(k) Exempt We supply:
Digital X-Ray Receptor Panel 892.1680 Class II Code MQB. Digital X-ray Software 892.2050 Class II Code LLZ. The software offered for sale with this system has received previous 510(k) clearance in K212291.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic images / X-ray
Anatomical Site
Human anatomy
Indicated Patient Age Range
Not Found
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)
Non clinical testing was performed according to the following standards: IEC 60601-1:2005/(R)2012 And A1:2012, IEC 60601-1-2:2014, and NEMA PS 3.1 - 3.20 (2011). The digital panel software employed was used unmodified from clearance obtained from FDA. The software has been validated as a control for CPI and Sedecal diagnostic x-ray generators. Since the three new digital receptor panels have not had previous FDA clearance, testing was performed according to the FDA guidance document: Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices, Guidance for Industry and Food and Drug Administration Staff. Clinical image evaluation was performed on the proposed new panels by a Board-Certified Radiologist. The images were found to be of excellent quality. The User Manuals contain pediatric and cybersecurity supplements. All proposed compatible generators carry NRTL listing labels, having been tested for safety. Validation of proper generator technique control had been previously performed.
Clinical testing was not required for a determination of substantial equivalence.
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
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is 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.
January 21, 2022
Konica Minolta Healthcare Americas, Inc. % Jan Maniscalco Executive Vice President of OA/RA 2217 US Highway 70 East GARNER NC 27529
Re: K214030
Trade/Device Name: Universal DR 1748 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: MQB, LLZ Dated: December 22, 2021 Received: December 23, 2021
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
1
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) 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 (OS) 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,
Laurel Burk Assistant Director Diagnostic X-ray Systems Team 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
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Indications for Use
510(k) Number (if known)
Device Name Universal DR 1748
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) |
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3
510(k) Summary K214030
Image /page/3/Picture/1 description: The image shows the Konica Minolta logo. The logo features a blue circle with several horizontal white lines across the middle. Below the circle, the text "KONICA MINOLTA" is written in a bold, sans-serif font.
KONICA MINOLTA
Konica Minolta Healthcare Americas, Inc. 2217 US Highway 70 East Garner, NC 27529 973.633.1500
1. Administrative Information
Reason for Submission: 510(k) Notification for Universal DR 1748
Submitter:
Submission contact person: Contact telephone: Contact e-mail: Date prepared:
Jan Maniscalco, Executive Vice President of QA/RA 973.633.1500 jan.maniscalco@konicaminolta.com December 22, 2021
Universal DR 1748 Identification: Classification Name: Stationary X-Ray System Classification Panel: Radiology Classification Regulation: 21 CFR §892.1680 Device Class: Class II Product Code: MQB, LLZ
Substantially equivalent device:
Trade Name: SKR 3000 Manufacturer: Konica Minolta Healthcare Americas, Inc 510(k) #: K210919 Classification Name: Stationary x-ray system Radiology Classification Panel: Classification Regulation: 21 CFR §892.1680 Class II Device Class: Product Code: MQB, LLZ
Reference Device: The device software "Ultra" was most recently cleared in K212291 Trade/Device Name: PHOENIX Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL, MQB
- Device description: Konica Minolta Universal DR 1748 combines components into a complete digital x-2. ray system upgrade kit, including software and digital radiography panel. The indications for use remains unchanged: This device is indicated for use in generating radiographic images of human anatomy. It is intended to a replace radiographic film/screen system in generalpurpose diagnostic procedures. This device is not indicated for use in mammography, fluoroscopy, and
4
angiography applications. So the only difference between this submission and the predicate submission is the manufacturer of the digital panel and the supplied software is different Each system consists of the following items:
Customer supplies: Diagnostic x-ray generator (HF) Class I Code IZO. + Tubehead: Class I Code ITY + Tube Mount: Class I Code IYB + Attached Collimator, Manual (IZX) Class II 510(k) Exempt We supply:
Digital X-Ray Receptor Panel 892.1680 Class II Code MQB. Digital X-ray Software 892.2050 Class II Code LLZ. The software offered for sale with this system has received previous 510(k) clearance in K212291.
-
- 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.
| Comparable
Properties | Konica Minolta SKR 3000 K210619 | Universal DR 1748 | Comparison
Results |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | 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. | SAME |
| Digital X-Ray
Detectors | P-65 and P-75 | Venu1748V | Different
Detector,
same
indications |
| Photo | Image: Digital X-Ray Detector | Image: Digital X-Ray Detector | Rectangular
and larger. |
| Panel
Performance | MTF (1 cycle/mm) 0.62
DQE (1.0 cycle/mm) 0.56
DQE (0 cycle/mm) 0.65 | MTF@1.0lp/mm 0.563
MTF@2.0lp/mm 0.244
MTF@3.0lp/mm 0.121
DQE@1.0lp/mm 0.205
DQE@2.0lp/mm 0.104
DQE@3.0lp/mm 0.052 | The difference is
explained by the
difference in
scintillator.
Diagnostic quality
images are
nevertheless
produced by the
new panel. |
| Comparable
Properties | Konica Minolta SKR 3000 K210619 | Universal DR 1748 | Comparison
Results |
| Number of
Pixels | 3,488 × 4,256 pixels or
4,248 × 4,248 pixels | 8704 x 3072 pixels | Larger image
can be
obtained with
one exposure
instead of two. |
| Pixel Pitch | 100 μm / 200 μm / 400 μm | 139um | SIMILAR |
| Scintillator | Csl (Cesium Iodide) | GOS | GOS offers
lower cost per
unit area. |
| A/D
Conversion | 16 bits | 16 bits | SAME |
| Panel Sizes | 14″ X 17″
17″ X 17″ | 17″ x 48″ | Proposed device
is a larger panel.
Allows for a much
larger image to be
captured with
one exposure |
| Data Interface | Ethernet or Wireless | Ethernet | Since this large
panel is not
moved very often
tethering is not a
serious
disadvantage |
| Operator
console | Windows PC using Windows 10 | SAME | SAME. |
| Acquisition
Software | Console CS-7
DICOM OUTPUT | ULTRA SOFTWARE
DICOM OUTPUT | Similar
performance
characteristics,
both previously
cleared |
| Power Source | AC Line or rechargeable batteries
(wireless models) | AC Line or rechargeable battery | SAME |
| Standards | Same as below | See below | SAME |
4. Technological characteristics: Comparison Table
5
5. Non clinical testing: Testing was performed according to the following standards:
| FDA
Recognition
Number | Standard
Developing
Organization | Standard Designation
Number And Date | Title Of Standard |
|------------------------------|----------------------------------------|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 19-4 | IEC | 60601-1:2005/(R)2012
And A1:2012 | Medical Electrical Equipment Part 1: General Requirements For
Basic Safety And Essential Performance (IEC 60601 1:2005, MOD) |
| 19-8 | IEC | 60601-1-2:2014 | Medical Electrical Equipment Part 12: General Requirements For
Basic Safety And Essential Performance Collateral Standard:
Electromagnetic Disturbances Requirements And Tests |
6
| FDA
Recognition
Number | Standard
Developing
Organization | Standard Designation
Number And Date | Title Of Standard |
|------------------------------|----------------------------------------|-----------------------------------------|--------------------------------------------------------------------|
| 12-238 | NEMA | PS 3.1 - 3.20 (2011) | NEMA Digital Imaging and Communications in Medicine (DICOM)
Set |
The digital panel software employed was used unmodified from clearance obtained from FDA. The software has been validated as a control for CPI and Sedecal diagnostic x-ray generators. Compatible CPI generators: CMP 200 Series. Compatible Sedecal generators: SFHR and SHF Series.
In recognition of possible cybersecurity threats to the software, we consulted this guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff. As a result, we updated our own internal standard operating procedures and added cybersecurity precautions to the software users' manuals.
Since the three new digital receptor panels have not had previous FDA clearance, testing was performed according to the FDA guidance document: Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices, Guidance for Industry and Food and Drug Administration Staff. Clinical image evaluation was performed on the proposed new panels by a Board-Certified Radiologist. The images were found to be of excellent quality. The User Manuals contain pediatric and cybersecurity supplements. All proposed compatible generators carry NRTL listing labels, having been tested for safety. Validation of proper generator technique control had been previously performed.
Each system is tested for proper integration prior to shipment to the customer. Since multiple configurations are available (generator and panel models), our service engineers fully test each new system upon installation at the customer site
- Clinical testing. Not required for a determination of substantial equivalence.
7. Substantial Equivalence Discussion.
When combined with a compatible generator/Tubestand combination the Accuvue+ performs the same functions as the predicate using the same technological methods to produce diagnostic x-ray images. In all material aspects, the Visaris and the Konica Minolta systems are substantially equivalent to each other.
8. Substantial Equivalence Conclusion:
After analyzing bench test results, risk analysis, and clinical evaluation, it is the conclusion of Konica Minolta LLC that the Konica Minolta Universal DR 1748 series of upgrade kits are as safe and effective as the predicate device, has few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device.