21.3” 5MP Color LCD Display UMD5-21B01

K241499 · Acula Technology Corp. · PGY · Jun 13, 2024 · Radiology

Device Facts

• Record ID: K241499
• Device Name: 21.3” 5MP Color LCD Display UMD5-21B01
• Applicant: Acula Technology Corp.
• Product Code: PGY · Radiology
• Decision Date: Jun 13, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

UMD5-21B01 is indicated for use in displaying radiological images (including full-field digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.

Device Story

21.3" 5MP color LCD display; inputs digital radiological images via DVI-D or DisplayPort from workstation/PC; utilizes IPS technology; features factory-calibrated display modes stored in internal Lookup Table (LUT) to ensure DICOM GSDF compliance; includes AcuCal-Pro firmware for standalone luminance calibration and quality control; includes AcuCal Manage PC application for fleet management; used in clinical settings by radiologists/physicians for diagnostic review; provides high-resolution visualization of medical images to support clinical decision-making and diagnostic accuracy.

Clinical Evidence

Bench testing only. Performance validated per FDA guidance for display devices. Metrics include MTF, pixel aperture ratio, pixel defect counts, temporal response, luminance range, DICOM GSDF conformance, angular luminance dependency, noise power spectrum (NPS), display reflections, small-spot contrast ratio, and chromaticity/luminance non-uniformity.

Technological Characteristics

21.3" TFT Color LCD (IPS); 5MP (2048x2560) resolution; 0.165mm pixel pitch; LED backlight; 10-bit/8-bit grayscale support; DVI-D and DisplayPort inputs; built-in front, ambient light, and backlight sensors; internal LUT for calibration; AC100-240V power; 85W max consumption.

Indications for Use

Indicated for trained medical practitioners to review, analyze, and diagnose radiological images, including full-field digital mammography and digital breast tomosynthesis.

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

• 5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+ (K200864)

Submission Summary (Full Text)

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ACULA Technology Corp. % Tzu-Wei Li Third Party Contact Center For Measurement Standards Of Industrial Bldg. 16, 321 Kuang Fu Rd.sec2 HSINCHU. TAIWAN

June 13, 2024

#### Re: K241499

Trade/Device Name: 21.3" 5MP Color LCD Display UMD5-21B01 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: May 28, 2024 Received: May 28, 2024

Dear Tzu-Wei Li:

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.

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).

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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.

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-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,

Jessica Lamb

Jessica Lamb, Ph.D., Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known)

#### K241499

#### Device Name

21.3" 5MP Color LCD Display UMD5-21B01

Indications for Use (Describe)

UMD5-21B01 is indicated for use in displaying radiological images (including full-field digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.

| Type of Use (Select one or both, as applicable) | <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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# K241499 510(k) Summary

#### I. SUBMITTER

ACULA Technology Corp. Address: No. 11, Alley 21, Lane 20, Rd. Dashing Luchu Dist., Taoyuan City, Taiwan 33862 Phone: [phone] Fax: [phone]

Contact Person: Sheng-Sung Jian Email: [e-mail] Date Prepared: Apr. 22, 2024

#### II. DEVICE

Name of Device: 21.3" 5MP Color LCD Display UMD5-21B01 Common or Usual Name: UMD5-21B01 Classification Name: Display, Diagnostic Radiology (21 CFR 892.2050) Regulatory Class: II Product Code: PGY

#### III. PREDICATE DEVICE

510(k) Number: K200864 Model Name: 5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+ Applicant: Shenzhen Beacon Display Technology Co., Ltd. Common Name: 5MP LCD Monitors C53S+, C53SP+, G53S+, G53SP+ Classification Name: Display, Diagnostic Radiology Regulation Number: 21 CFR 892.2050 Product Code: PGY Device Class: 2

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## IV. DEVICE DESCRIPTION

UMD5-21B01 is a 5 mega pixels 21.3" color LCD display for viewing medical images including mammography and digital breast tomosynthesis. The resolution of the display is 2,048 x 2,560 pixels (5MP) with a pixel pitch of 0.165 mm and wide angle LCD technology (IPS) support Dual-link DVI and Displayport signals from workstation or personal computer.

Since factory calibrated 3 display modes, each of which is characterized by a specific curve (including DICOM GSDF), a specific luminance range and a pre-defined color temperature, are stored in Lookup Table (LUT) within the display, the tone curve is e.g. DICOM compliant regardless of the display controller used.

AcuCal, a general name for the calibration and quality control functions of UMD-series product, includes corresponding firmware (AcuCal-Pro) and management application of PC (AcuCal Manage). AcuCal-Pro is the controlling firmware of this LCD display. AcuCal-Pro can perform the luminance calibration without PC or workstation and also includes the quality control scheme to make sure display quality, especially DICOM conformance. AcuCal Manage is a PC application for managing a group of displays.

## V. INDICATIONS FOR USE

The UMD5-21B01 is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.

## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The comparison table below provides information to support the substantial equivalence between the proposed device Color LCD Display UMD5-21B01 and predicate device Color LCD Display C53S+, C53SP+ (K200864) in terms of intended use, application and technological characteristics.

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| Comparison<br>Item | Proposed Device<br>21.3" 5MP Color LCD<br>Display UMD5-21B01 | Predicate Device<br>21.3" 5MP Color LCD<br>Display C53S+,<br>C53SP+ | Explanation of<br>Differences |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | Unknown | K200864 | |
| Intended Use | The UMD5-21B01 is<br>indicated for use in<br>displaying radiological<br>images (including<br>full-field digital<br>mammography and<br>digital breast<br>tomosynthesis) for<br>review, analysis, and<br>diagnosis by trained<br>medical practitioners | The 5MP Color LCD<br>Monitors C53S+,<br>C53SP+ and 5MP<br>Monochrome LCD<br>Monitors G53S+,<br>G53SP+ are intended<br>to be used in<br>displaying and<br>viewing medical<br>images for diagnosis<br>by trained medical<br>practitioners or<br>certified personnel.<br>They're intended to<br>be used in digital<br>mammography<br>PACS, digital breast<br>tomosynthesis and<br>modalities including<br>FFDM | Same |
| Screen<br>Technology | TFT Color LCD Panel<br>(IPS) | TFT Color LCD Panel<br>(IPS) | Same |
| Viewing angle | CR>10<br>Horizontal: Typ.178<br>Vertical: Typ.178 | CR>10<br>Horizontal: Typ.178<br>Vertical: Typ.178 | Same |
| Resolution | 5MP (2048 x 2560) | 5MP (2048 x 2560) | Same |
| Aspect ratio | 4:5 | 4:5 | Same |
| Display area | Horizontal: 337.92mm<br>Vertical: 422.4mm | Horizontal: 337.92mm<br>Vertical: 422.4mm | Same |
| Pixel pitch | Horizontal: 0.165mm<br>Vertical: 0.165mm | Horizontal: 0.165mm<br>Vertical: 0.165mm | Same |
| Response time<br>(Typ.) | 25ms (On/Off) | 25ms (On/Off) | Same |
| Maximum<br>luminance | Min. 920cd/m2<br>Typ. 1,150cd/m2 | Min. 920cd/m2<br>Typ. 1,150cd/m2 | Same |
| DICOM<br>calibrated<br>luminance | 500cd/m2 | 500cd/m2 | Same |
| Contrast ratio | Min. 1600:1<br>Typ. 2000:1 | Min. 1600:1<br>Typ. 2000:1 | Same |
| Backlighting | LED | LED | Same |
| Grayscale<br>Tones | 10-bit (DisplayPort):<br>1.073 billion<br>1024 from a palette of<br>16,384 tones<br>8-bit(DVI): 16.77<br>million 256 from a<br>palette of 16,384<br>tones | 10-bit (DisplayPort):<br>1.073 billion<br>1024 from a palette of<br>16,384 tones<br>8-bit(DVI): 16.77<br>million 256 from a<br>palette of 16,384<br>tones | Same |
| Luminance<br>non-uniformity<br>Compensation | - | - | Same |
| Input Video<br>Signals | DVI-D x1<br>DisplayPort x1 | DVI-D x1<br>DisplayPort x1 | Same |
| Scanning<br>Frequency | Landscape:<br>Horizontal: 104.852KHz<br>Vertical: 50Hz | Landscape:<br>Horizontal: 104.852KHz<br>Vertical: 50Hz | Same |
| Dot Clock | 285 MHz | 285 MHz | Same |
| Power<br>Requirements | AC100-240V,<br>50/60Hz | DC 12V, 6.67A | Different between<br>built-in power supply<br>and built-out power<br>supply |
| Power<br>Consumption /<br>Save Mode | 85W<br>Less than 1W | 80W<br>Less than 5W | In comparison with<br>predicate device,<br>UMD5-21B01<br>maximum power is<br>higher, but it<br>consumes less<br>power in standby |
| | | | mode. |
| Power<br>Management | DVI DPMS,<br>DisplayPort 1.2a | DVI DPMS,<br>DisplayPort 1.2 | Different spec.<br>version between<br>DisplayPort 1.2 and<br>DisplayPort 1.2a |
| QC Software | AcuCal | Beacon Monitor<br>Manage | Different design |
| Sensors | Built-in Front Sensor<br>Built-in ambient Light<br>Sensor<br>Built-in Backlight<br>Sensor | Built-in Front Sensor<br>(Only for C53SP+)<br>Built-in ambient Light<br>Sensor<br>Built-in Backlight<br>Sensor | Same |
| USB Ports /<br>Standard | 1 upstream,<br>3 downstream / Rev.<br>2.0 | 1 upstream,<br>2 downstream / Rev.<br>2.0 | In comparison with<br>predicate device,<br>UMD5-21B01 has<br>one more<br>downstream USB<br>Port for service use |
| Dimensions<br>w/o Stand<br>(W x H x D) | 359 x 458 x 75.9 mm | 395.3 x 549.6/629.6 x 234.8 mm | Different industrial<br>design |

UMD5-21B01 510(k) Submission

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According to the above table, UMD5-21B01 is a medical device which has the same intended use as the predicate device. The difference in the above statement does not change the intended use. As a result, both devices have fundamentally the same intended use.

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#### VII. PERFORMANCE DATA

The performance data bench tests below were performed on the UMD5-21B01 following the instructions in "Guidance for Industry and Food and Drug Administration Staff: Display Devices for Diagnostic Radiology":

- Measurement of spatial resolution expressed as modulation transfer function (MTF)
- Measurement of pixel aperture ratio
- The maximum number allowed for each type of pixel defects/faults
- Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline)
- Measurement of temporal response Performance data (provided by Innolux, LCD panel vender)
- Measurements of the maximum and minimum luminance that the device outputs as used in the application under recommended conditions and the achievable values
- Verification of the conformance to DICOM GSDF as specified in TG18 quideline
- Measurement of the angular dependency of luminance response in horizontal, vertical and diagonal directions
- Measurement of noise expressed as noise power spectrum (NPS)
- Measurement of display reflections including specular, diffuse and glare components
- Measurement of small-spot contrast ratio
- Measurement of the chromaticity non-uniformity characteristics of the display screen as specified in TG18 guideline
- Measurement of the luminance non-uniformity characteristics of the display screen as specified in TG18 guideline

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#### XIII. CONCLUSIONS

After analyzing all testing data and comparing it with the predicated device, it can be concluded that UMD5-21B01 is substantially equivalent to the predicate device (K200864) with respect to technological characteristic, application and intended use.

The specifications of the primary component employed by the proposed device are the same as those of the predicate device, and other differences have been independently validated. Any differences between the devices do not affect safety or effectiveness.