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.

Device Description

Konica Minolta Universal DR 1748 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography panel.

AI/ML Overview

This document describes the regulatory submission for the Universal DR 1748, an upgrade kit for digital X-ray systems. It asserts substantial equivalence to a predicate device, the Konica Minolta SKR 3000 (K210619). The primary difference is the digital X-ray panel and associated software.

However, the provided text does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 regarding acceptance criteria and the detailed study that proves the device meets those criteria for the AI/Software component (Ultra software).

The mention of the "Ultra" software suggests it is a crucial component of the new system, having been previously cleared (K212291). The relevant part states: "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."

This means that the software's performance and validation were established in its prior clearance (K212291) and are not re-evaluated in detail within this specific K214030 submission summary. The current submission focuses on the integration of this pre-cleared software with new hardware components (the Venu1748V digital panel).

Therefore, based solely on the provided text, I cannot extract the specific details about the acceptance criteria and the study proving the software's performance. The document only confirms that the software was "unmodified" from a previously cleared version and "validated as a control" for certain generators.

To provide the requested information, one would need to access the K212291 submission for the "Ultra" software, as that is where its performance studies would have been detailed.

Summary

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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

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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)

K214030

Device Name Universal DR 1748

Indications for Use (Describe)

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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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

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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.

1. 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.

ComparableProperties	Konica Minolta SKR 3000 K210619	Universal DR 1748	ComparisonResults
Indications foruse	This device is indicated for use ingenerating radiographic images ofhuman anatomy. It is intended to areplace radiographic film/screensystem in general-purpose diagnosticprocedures. This device is notindicated for use in mammography,fluoroscopy, and angiographyapplications.	This device is indicated for use ingenerating radiographic images ofhuman anatomy. It is intended to areplace radiographic film/screensystem in general-purpose diagnosticprocedures. This device is notindicated for use in mammography,fluoroscopy, and angiographyapplications.	SAME
Digital X-RayDetectors	P-65 and P-75	Venu1748V	DifferentDetector,sameindications
Photo	Image: Digital X-Ray Detector	Image: Digital X-Ray Detector	Rectangularand larger.
PanelPerformance	MTF (1 cycle/mm) 0.62DQE (1.0 cycle/mm) 0.56DQE (0 cycle/mm) 0.65	MTF@1.0lp/mm 0.563MTF@2.0lp/mm 0.244MTF@3.0lp/mm 0.121DQE@1.0lp/mm 0.205DQE@2.0lp/mm 0.104DQE@3.0lp/mm 0.052	The difference isexplained by thedifference inscintillator.Diagnostic qualityimages areneverthelessproduced by thenew panel.
ComparableProperties	Konica Minolta SKR 3000 K210619	Universal DR 1748	ComparisonResults
Number ofPixels	3,488 × 4,256 pixels or4,248 × 4,248 pixels	8704 x 3072 pixels	Larger imagecan beobtained withone exposureinstead of two.
Pixel Pitch	100 μm / 200 μm / 400 μm	139um	SIMILAR
Scintillator	Csl (Cesium Iodide)	GOS	GOS offerslower cost perunit area.
A/DConversion	16 bits	16 bits	SAME
Panel Sizes	14″ X 17″17″ X 17″	17″ x 48″	Proposed deviceis a larger panel.Allows for a muchlarger image to becaptured withone exposure
Data Interface	Ethernet or Wireless	Ethernet	Since this largepanel is notmoved very oftentethering is not aseriousdisadvantage
Operatorconsole	Windows PC using Windows 10	SAME	SAME.
AcquisitionSoftware	Console CS-7DICOM OUTPUT	ULTRA SOFTWAREDICOM OUTPUT	Similarperformancecharacteristics,both previouslycleared
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

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5. Non clinical testing: Testing was performed according to the following standards:

FDARecognitionNumber	StandardDevelopingOrganization	Standard DesignationNumber And Date	Title Of Standard
19-4	IEC	60601-1:2005/(R)2012And A1:2012	Medical Electrical Equipment Part 1: General Requirements ForBasic Safety And Essential Performance (IEC 60601 1:2005, MOD)
19-8	IEC	60601-1-2:2014	Medical Electrical Equipment Part 12: General Requirements ForBasic Safety And Essential Performance Collateral Standard:Electromagnetic Disturbances Requirements And Tests

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FDARecognitionNumber	StandardDevelopingOrganization	Standard DesignationNumber 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.

Regulation Number and Section

N/A