Universal DR 1748

K214030 · Konica Minolta Healthcare Americas, Inc. · MQB · Jan 21, 2022 · Radiology

Device Facts

• Record ID: K214030
• Device Name: Universal DR 1748
• Applicant: Konica Minolta Healthcare Americas, Inc.
• Product Code: MQB · Radiology
• Decision Date: Jan 21, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended 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.

Device Story

Universal DR 1748 is a digital X-ray system upgrade kit; consists of a digital X-ray receptor panel (Venu1748V) and Ultra software. Input: X-ray radiation transmitted through human anatomy; captured by GOS scintillator-based digital panel. Transformation: Panel converts X-ray energy to digital signals; software processes data for display. Output: Diagnostic radiographic images. Used in clinical settings; operated by healthcare professionals. Output viewed on Windows PC console; assists clinicians in diagnostic decision-making. Benefits: Enables capture of larger images in a single exposure compared to smaller panels; replaces traditional film/screen systems.

Clinical Evidence

No clinical trials performed. Substantial equivalence supported by bench testing and clinical image evaluation. A board-certified radiologist evaluated images produced by the new panels and confirmed excellent quality. Bench testing included performance metrics (MTF, DQE) and compliance with IEC 60601-1 and IEC 60601-1-2 standards.

Technological Characteristics

Digital X-ray upgrade kit. Detector: GOS scintillator, 17" x 48" form factor, 139um pixel pitch, 16-bit A/D conversion. Connectivity: Ethernet. Power: AC line or rechargeable battery. Software: Ultra software (previously cleared). Standards: IEC 60601-1, IEC 60601-1-2, DICOM PS 3.1-3.20.

Indications for Use

Indicated for generating radiographic images of human anatomy in general-purpose diagnostic procedures. Not 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 (K210619)

Reference Devices

• PHOENIX (K212291)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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) | |
|------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><span style="font-size:20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><span style="font-size:20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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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 [e-mail] 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.

- 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.

| Comparable<br>Properties | Konica Minolta SKR 3000 K210619 | Universal DR 1748 | Comparison<br>Results |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>use | This device is indicated for use in<br>generating radiographic images of<br>human anatomy. It is intended to a<br>replace radiographic film/screen<br>system in general-purpose diagnostic<br>procedures. This device is not<br>indicated for use in mammography,<br>fluoroscopy, and angiography<br>applications. | This device is indicated for use in<br>generating radiographic images of<br>human anatomy. It is intended to a<br>replace radiographic film/screen<br>system in general-purpose diagnostic<br>procedures. This device is not<br>indicated for use in mammography,<br>fluoroscopy, and angiography<br>applications. | SAME |
| Digital X-Ray<br>Detectors | P-65 and P-75 | Venu1748V | Different<br>Detector,<br>same<br>indications |
| Photo | Image: Digital X-Ray Detector | Image: Digital X-Ray Detector | Rectangular<br>and larger. |
| Panel<br>Performance | MTF (1 cycle/mm) 0.62<br>DQE (1.0 cycle/mm) 0.56<br>DQE (0 cycle/mm) 0.65 | MTF@1.0lp/mm 0.563<br>MTF@2.0lp/mm 0.244<br>MTF@3.0lp/mm 0.121<br>DQE@1.0lp/mm 0.205<br>DQE@2.0lp/mm 0.104<br>DQE@3.0lp/mm 0.052 | The difference is<br>explained by the<br>difference in<br>scintillator.<br>Diagnostic quality<br>images are<br>nevertheless<br>produced by the<br>new panel. |
| Comparable<br>Properties | Konica Minolta SKR 3000 K210619 | Universal DR 1748 | Comparison<br>Results |
| Number of<br>Pixels | 3,488 × 4,256 pixels or<br>4,248 × 4,248 pixels | 8704 x 3072 pixels | Larger image<br>can be<br>obtained with<br>one exposure<br>instead of two. |
| Pixel Pitch | 100 μm / 200 μm / 400 μm | 139um | SIMILAR |
| Scintillator | Csl (Cesium Iodide) | GOS | GOS offers<br>lower cost per<br>unit area. |
| A/D<br>Conversion | 16 bits | 16 bits | SAME |
| Panel Sizes | 14″ X 17″<br>17″ X 17″ | 17″ x 48″ | Proposed device<br>is a larger panel.<br>Allows for a much<br>larger image to be<br>captured with<br>one exposure |
| Data Interface | Ethernet or Wireless | Ethernet | Since this large<br>panel is not<br>moved very often<br>tethering is not a<br>serious<br>disadvantage |
| Operator<br>console | Windows PC using Windows 10 | SAME | SAME. |
| Acquisition<br>Software | Console CS-7<br>DICOM OUTPUT | ULTRA SOFTWARE<br>DICOM OUTPUT | Similar<br>performance<br>characteristics,<br>both previously<br>cleared |
| Power Source | AC Line or rechargeable batteries<br>(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:

| FDA<br>Recognition<br>Number | Standard<br>Developing<br>Organization | Standard Designation<br>Number And Date | Title Of Standard |
|------------------------------|----------------------------------------|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 19-4 | IEC | 60601-1:2005/(R)2012<br>And A1:2012 | Medical Electrical Equipment Part 1: General Requirements For<br>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<br>Basic Safety And Essential Performance Collateral Standard:<br>Electromagnetic Disturbances Requirements And Tests |

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| FDA<br>Recognition<br>Number | Standard<br>Developing<br>Organization | Standard Designation<br>Number And Date | Title Of Standard |
|------------------------------|----------------------------------------|-----------------------------------------|--------------------------------------------------------------------|
| 12-238 | NEMA | PS 3.1 - 3.20 (2011) | NEMA Digital Imaging and Communications in Medicine (DICOM)<br>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

6. 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.