Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT)

K191845 · Barco N.V. · PGY · Sep 6, 2019 · Radiology

Device Facts

• Record ID: K191845
• Device Name: Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT)
• Applicant: Barco N.V.
• Product Code: PGY · Radiology
• Decision Date: Sep 6, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The display is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. The Intuitive Workflow Tools are intended to be used as accessories for image enhancement in diagnostic displays.

Device Story

Coronis Fusion 6MP (MDCC-6530) and 4MP (MDCC-4430) are high-resolution color diagnostic displays; Intuitive Workflow Tools (IWT) are software accessories for image enhancement. Displays receive digital image data from PACS or imaging modalities (CT, MR, US, DR, CR, NM); transform inputs via IPS-Pro LCD panels with integrated I-Guard front sensors and ambient light sensors for DICOM-calibrated luminance; output high-fidelity images for clinical review. Used in clinical reading rooms by radiologists/physicians. IWT software enhances image presentation. Devices feature internal power supplies, updated firmware, and VESA-mount compatibility. Output enables diagnostic interpretation and clinical decision-making; benefits include improved visualization of diagnostic images for accurate patient assessment.

Clinical Evidence

Bench testing only. No clinical data provided. Performance validated via bench test equivalence reports, environmental testing, electrical safety testing, and EMC testing. All tests passed.

Technological Characteristics

IPS LCD panels; 6MP (MDCC-6530) or 4MP (MDCC-4430) resolution; 30-bit color depth; 178-degree viewing angle; I-Guard front sensor; ambient light sensor; 2x DP1.2 video inputs; 1x DP (MST) output; USB 2.0 ports; VESA 100mm mount; anti-reflective glass cover; internal power supply (100-240V); QAWeb software for calibration.

Indications for Use

Indicated for trained medical practitioners to display and view digital images (excluding digital mammography) for review and analysis. Intuitive Workflow Tools are indicated as accessories for image enhancement in diagnostic displays.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• Coronis Fusion 6MP (MDCC-6230) (K130103)

Submission Summary (Full Text)

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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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 6, 2019

Barco NV % Ms. Julie Vandecandelaere Regulatory Affairs Officer President Kennedypark 35 8500 Kortrijk W-VL BELGIUM

## Re: K191845

Trade/Device Name: Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: July 5, 2019 Received: July 10, 2019

Dear Ms. Vandecandelaere:

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

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

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## Indications for Use

510(k) Number (if known)

#### K191845

Device Name MDCC-6530 MDCC-4430 Intuitive Workflow Tools (IWT)

Indications for Use (Describe)

The display is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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## Indications for Use

510(k) Number (if known)

Device Name MDCC-4430

Indications for Use (Describe)

The display is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.

Type of Use (Select one or both, as applicable)

| <div> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|--------------------------------------------------------------------|
| <div> ☐ Over-The-Counter Use (21 CFR 801 </div> |

---

| | 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 [e-mail]

"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."

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## Indications for Use

510(k) Number (if known)

Device Name Intuitive Workflow Tools

Indications for Use (Describe)

The Intuitive Workflow Tools are intended to be used as accessories for image enhancement in diagnostic displays.

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> |

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 [e-mail]

"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."

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| 510(k) Summary (in accordance with 21 CFR 807.92) | | | K191845 | |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. Company | Barco N.V.<br>Healthcare Division<br>35 President Kennedypark<br>B-8500 Kortrijk<br>BELGIUM | | | |
| 2. Contact person | Julie Vandecandelaere<br>Regulatory Affairs Officer<br>Tel: [phone]<br>[e-mail] | | | |
| 3. Date of<br>submission | 05 July 2019 | | | |
| 4. Device<br>information | Trade name/model: | Coronis Fusion 6MP (MDCC-6530)<br>Coronis Fusion 4MP (MDCC-4430)<br>Intuitive Workflow Tools (IWT) | | |
| | Common name: | MDCC-6530<br>MDCC-4430<br>Intuitive Workflow Tools (IWT) | | |
| | Classification name:<br>Classification code:<br>Regulation number: | System, image processing, Radiological<br>PGY<br>892.2050 | | |
| 5. Predicate<br>device | Coronis Fusion 6MP (MDCC-6230) cleared under 510(K) K130103 | | | |
| 6. Device<br>description | | The MDCC-6530 is a derivative of the MDCC-6230.<br>✓ Updated Liquid Crystal Display technology, providing a higher Contrast Ratio<br>✓ New housing, display stand and internal mechanics<br>✓ Change in electronics board, including integration of the power supply adaptor into the device<br>✓ Updated firmware<br>✓ New packaging | | |
| 7. Intended Use of<br>the Device | The MDCC-4430 only differs from MDCC-6530 in having a 4MP panel instead of a 6MP panel.<br>The Intuitive Workflow Tools package includes some software tools that are intended to support the intended use of the diagnostic displays by performing image enhancement.<br>The display is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.<br>Note: There are no changes to the indications for use statement from that of the | | | |
| | unmodified device.<br>The Intuitive Workflow Tools are intended to be used as accessories for image enhancement in diagnostic displays. | | | |
| | 8. Comparison of<br>technological<br>characteristics | Item | Predicate Device<br>(K130103) | Device for which<br>listing is sought |
| Device name | | Coronis Fusion 6MP<br>(MDCC-6230) | Coronis Fusion 6MP<br>(MDCC-6530) | Coronis Fusion 4MP<br>(MDCC-4430) |
| Screen<br>technology | | TFT AM Color LCD<br>Dual Domain IPS-Pro | IPS | IPS |
| Active screen<br>size (diagonal) | | 772 mm (30.4") | 772 mm (30.4") | 772 mm (30.4") |
| Active screen<br>size (HxV) | | 654 x 409 mm (25.8 x<br>16.1") | 654 x 409 mm (25.8 x<br>16.1") | 655 x 410 mm (25.8 x<br>16.1") |
| Aspect ratio<br>(H:V) | | 16:10 | 16:10 | 16:10 |
| Resolution | | Native 6MP (3280 x<br>2048 pixels)<br>Configurable to 2 x<br>3MP+ (1640 x 2048<br>pixels)<br>Configurable to 2 x<br>3MP (1536 x 2048<br>pixels) | Native 6MP (3280 x<br>2048 pixels)<br>Configurable to 2 x<br>3MP+ (1640 x 2048<br>pixels)<br>Configurable to 2 x<br>3MP (1536 x 2048<br>pixels) | Native 4MP (2560 x<br>1600 pixels)<br>Configurable to 2 x<br>2MP+ (1280 x 1600<br>pixels)<br>Configurable to 2 x<br>2MP (1200 x 1600<br>pixels) |
| Pixel pitch | | 0.1995 mm | 0.1995 mm | 0.256 mm |
| Color imaging | | Yes | Yes | Yes |
| Gray imaging | | Yes | Yes | Yes |
| | Bit depth | 30 bit | 30 bit | 30 bit |
| | Viewing angle<br>(H, V) | 178° | 178° | 178° |
| | Uniformity<br>Correction | ULT | ULT - Color PPU | ULT - Color PPU |
| | Ambient Light<br>Presets | Yes, reading room<br>selection | Yes, reading room<br>selection | Yes, reading room<br>selection |
| | Ambient Light<br>Sensor | Yes | Yes | Yes |
| | Front sensor | Yes, I-Guard | Yes, I-Guard | Yes, I-Guard |
| Maximum<br>luminance<br>(panel typical) | 720 Cd/m² | 1050 Cd/m² | 1050 cd/m² | |
| DICOM<br>calibrated<br>luminance | 500 Cd/m² | 600 Cd/m² | 600 cd/m² | |
| Contrast ratio<br>(panel typical) | 1000:1 | 2000:1 | 2000:1 | |
| Response<br>time (panel<br>typical data [1])<br>Tr,typ | 9 ms | 20 ms | 20 ms | |
| T f,typ | 9 ms | 16 ms | 16 ms | |
| Housing color | Black / Silver<br>DVI-D Dual Link (2x),<br>DisplayPort (2x) | Black / White<br>2 x DP1.2 | Black / White<br>2 x DP1.2 | |
| Video output<br>signals | N/A | 1 x DP (MST) | 1 x DP (MST) | |
| USB ports | 1x USB 2.0 upstream<br>(endpoint)<br>3x USB 2.0<br>downstream | 1x USB 2.0 upstream<br>(endpoint)<br>2x USB 2.0<br>downstream<br>1x USB 2.0<br>downstream with<br>high-power charging<br>functionality | 1x USB 2.0 upstream<br>(endpoint)<br>2x USB 2.0<br>downstream<br>1x USB 2.0<br>downstream with<br>high-power charging<br>functionality | |
| Power rating | 100-240V | 100-240 Vac, 50/60<br>Hz, 3.6-1.6 A | 100-240 Vac, 50/60<br>Hz, 3.6-1.6 A | |
| Power<br>consumption | 125W | 110 W (nominal) @<br>calibrated luminance<br>of 600 cd/m²<br>< 0.5 W (hibernate)<br>< 0.5 W (standby) | 110 W (nominal) @<br>calibrated luminance<br>of 600 cd/m²<br>< 0.5 W (hibernate)<br>< 0.5 W (standby) | |
| Dimensions<br>with stand (W<br>x H x D) | 731 x 580~676 x 265<br>mm | 714 x 524~624 x 240<br>mm | 714 x 524~624 x 240<br>mm | |
| Dimensions<br>without stand<br>(W x H x D) | 731 x 485 x 141 mm | 714 x 478 x 74 mm | 714 x 478 x 74 mm | |
| Dimensions<br>packaged (W<br>x H x D) | 869 x 764 x 400 mm | 800 x 650 x 300 mm | 800 x 650 x 300 mm | |
| Net weight<br>with stand | 26.5 kg | 17.7 kg | 17.7 kg | |
| Net weight<br>without stand | 20 kg | 13.1 kg | 13.1 kg | |
| Net weight<br>packaged | 36.5 kg | 22.3 kg (without<br>optional accessories) | 22.3 kg (without<br>optional accessories) | |
| Tilt | -5° to +25° | -5° to +25° | -5° to +25° | |
| Swivel | -45° to +45° | -30° to +30° | -30° to +30° | |
| | Pivot | N/A | N/A | N/A |
| | Height<br>adjustment<br>range | 96 mm | 100 mm | 100 mm |
| | Mounting<br>standard | VESA (100 mm) | VESA (100 mm) | VESA (100 mm) |
| | Screen<br>protection | Protective, anti-<br>reflective glass cover | Protective, anti-<br>reflective glass cover | Protective, anti-<br>reflective glass cover |
| | Recommende<br>d modalities | CT, MR, US, DR, CR,<br>NM, Film | All digital images,<br>except digital<br>mammography. | All digital images,<br>except digital<br>mammography. |
| | Supplied<br>accessories | User Guide<br>Quick Installation<br>Sheet<br>Documentation disc | User Guide<br>Documentation disc | User Guide<br>Documentation disc |
| | | System disc<br>Video cables<br>Mains cables<br>USB cable<br>External power<br>supply | Video cables<br>Mains cables<br>USB cable | Video cables<br>Mains cables<br>USB cable |
| | Optional<br>accessories | Graphics board | Graphics board<br>Touch pad | Graphics board<br>Touch pad |
| | QA software | QAWeb | QAWeb | QAWeb |
| | Warranty | 5 years | 5 years, including<br>40,000 hours<br>backlight warranty | 5 years, including<br>40,000 hours<br>backlight warranty |
| | Operating<br>temperature | 0 °C to 35 °C (15 °C<br>to 30 °C within specs) | 0 °C to 35 °C (15 °C<br>to 30 °C within specs) | 0…