(235 days)
Not Found
No
The document describes a medical display device with calibration and quality control features, but there is no mention of AI or ML being used for image analysis, diagnosis, or any other function. The "AcuCal" system appears to be a standard calibration and management tool.
No.
The device is a medical display used for viewing radiological images for diagnosis, not for providing therapy.
No
The device is a medical display, which is a tool for displaying images for diagnosis, not a diagnostic device itself that performs diagnostic functions.
No
The device description clearly states it is a 3 mega pixels 21.3" color LCD display, which is a hardware component. While it includes software (AcuCal-Pro firmware and AcuCal Manage PC application), the core device is a physical display.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for various health issues.
- Device Function: The description clearly states that the UMD3-21B01 is a display device used for viewing radiological images. It receives signals from a workstation or computer and presents visual information to trained medical practitioners for review, analysis, and diagnosis.
- Lack of Biological Sample Interaction: The device does not interact with or analyze any biological samples from a patient. Its function is solely to display images generated by other medical imaging modalities (like X-ray, CT, MRI, etc.).
The information provided focuses on the technical specifications of the display, its calibration for medical imaging standards (like DICOM), and performance testing related to image quality and display characteristics. These are all typical characteristics of a medical image display device, not an IVD.
N/A
Intended Use / Indications for Use
The 3MP Color LCD Display UMD3-21B01) is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.
Product codes (comma separated list FDA assigned to the subject device)
PGY
Device Description
UMD3-21B01 (MD3-21B01) is a 3 mega pixels 21.3" color LCD display for viewing medical images, not including mammography. The resolution of the display is 1,536 x 2,048 pixels (3MP) with a pixel pitch of 0.2115 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 MD-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 Mange is a PC application for managing a group of displays.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical practitioners
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)
The performance tests below were performed on the UMD3-21B01 (MD3-21B01) 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 ● UMD3-21B01 (MD3-21B01) 510(k) Submission
- Measurement of the angular dependency of luminance response in horizontal, vertical and diagonal directions
- Measurement of the chromaticity non-uniformity characteristics of the display screen as specified in TG18 guideline
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.
Not Found
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
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
0
May 21, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
ACULA Technology Corp Sheng-Sung Jian Director of R&D 11, Alley 21, Lane 20, Rd. Dashing, Luchu Dist. TAOYUAN, 33862 TAIWAN
Re: K233336
Trade/Device Name: 21.3" 3MP Color LCD Display UMD3-21B01 (MD3-21B01) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: PGY Dated: April 12, 2024 Received: April 16, 2024
Dear Sheng-Sung Jian:
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).
1
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 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,
Samul for
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
2
Indications for Use
510(k) Number (if known)
Device Name
21.3" 3MP Color LCD Display UMD3-21B01(MD3-21B01)
Indications for Use (Describe)
The 3MP Color LCD Display UMD3-21B01) is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K233336
510(k) Summary
I. SUBMITTER
ACULA Technology Corp. Address: No. 11, Alley 21, Lane 20, Rd. Dashing Luchu Dist., Taoyuan City, Taiwan 33862 Phone: +886-3-3135577 Fax: +886-3-3233355 Contact Person: Sheng-Sung Jian Email: SSJian@acula.com.tw Date Prepared: September 19, 2023
DEVICE ==
Name of Device: 21.3" 3MP Color LCD Display UMD3-21B01 (MD3-21B01) Common or Usual Name: UMD3-21B01 (MD3-21B01) Classification Name: Display, Diagnostic Radiology (21 CFR 892.2050) Regulatory Class: II Product Code: PGY
III. PREDICATE DEVICE
510(k) Number: K201211 Model Name: C32S+, C32SP+ Applicant: Shenzhen Beacon Display Technology Co., Ltd. Common Name: 3MP LCD Monitors C32S+, C32SP+ Classification Name: Display, Diagnostic Radiology Regulation Number: 21 CFR 892.2050 Product Code: PGY Device Class: 2
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IV. DEVICE DESCRIPTION
UMD3-21B01 (MD3-21B01) is a 3 mega pixels 21.3" color LCD display for viewing medical images, not including mammography. The resolution of the display is 1,536 x 2,048 pixels (3MP) with a pixel pitch of 0.2115 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 MD-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 Mange is a PC application for managing a group of displays.
- ** UMD3-21B01 and MD3-21B01 refer to the same monitor. UMD3-21B01 is registered trade name for Acula Technology Corporation. MD3-21B01 is the model name for Acula Technology Corporation.
V. INDICATIONS FOR USE
The 3MP Color LCD Display UMD3-21B01 (MD3-21B01) is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
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The comparison table below provides information to support the substantial equivalence between the proposed device Color LCD Display UMD3-21B01 (MD3-21B01) and predicate device Color LCD Display C32S+, C32SP+ (K201211) in terms of intended use, application and technological characteristics.
| Comparison
Item | Proposed Device
21.3" 3MP Color LCD
Display UMD3-21B01
(MD3-21B01) | Predicate Device 21.3"
3MP Color LCD
Display C32S+,
C32SP+ | Explanation of
Differences |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | Unknown | K201211 | |
| Intended Use | The 3MP Color LCD
Display UMD3-21B01
(MD3-21B01) is
indicated for use in
displaying radiological
images for review,
analysis, and
diagnosis by trained
medical practitioners.
The display is not
intended for
mammography. | The 3MP Color LCD
Monitors C32S+,
C32SP+ are indicated
for use in displaying
radiological images for
review, analysis, and
diagnosis by trained
medical practitioners.
The displays are not
intended for
mammography. | Same |
| Display
technology | Color (IPS) | Color (IPS) | Same |
| Screen size | 54.1cm / 21.3"
Aspect ratio: 3:4 | 54.1cm / 21.3"
Aspect ratio: 3:4 | Same |
| Viewing angle | Horizontal: Typ.178
Vertical: Typ.178 | Horizontal: Typ.178
Vertical: Typ.178 | Same |
| Native resolution | 1536 x 2048 | 1536 x 2048 | Same |
| Viewable image
size | Horizontal: 324.86mm
Vertical: 433.15mm | Horizontal: 324.86mm
Vertical: 433.15mm | Same |
| | | | |
| Pixel pitch | Horizontal: 0.2115mm
Vertical: 0.2115mm | Horizontal: 0.2115mm
Vertical: 0.2115mm | Same |
| Response time
(typical) | 25ms (On/Off) | 25ms (On/Off) | Same |
| Brightness
(typical) | 1,000cd/m2 | 1,000cd/m2 | Same |
| Recommended
brightness for | 500cd/m2 | 500cd/m2 | Same |
| Contrast ratio
(typical) | 1500:1 | 1500:1 | Same |
| Backlight type | LED | LED | Same |
| Display colors | 10-bit (DisplayPort):
1.073 billion 1024 from a palette of 16,384 tones
8-bit(DVI): 16.77 million 256 from a palette of 16,384 tones | 10-bit (DisplayPort):
1.073 billion 1024 from a palette of 16,384 tones 8-bit(DVI): 16.77 million 256 from a palette of 16,384 tones | Same |
| Input Video
Signal | DVI-D (dual link) x1
DisplayPort x1 | DVI-D (dual link) x1
DisplayPort x1 | Same |
| Scanning
Frequency (H, V) | 31 - 97 kHz/59 - 61 Hz | 31 - 97 kHz/59 - 61 Hz | Same |
| Video bandwidth | DVI: 216 MHz
DisplayPort: 216 MHz | DVI: 216 MHz
DisplayPort: 216 MHz | Same |
| Power
Requirements | AC100-240V,
50/60Hz | DC 12 V / 6.67 A | Difference between
built-in power
supply and built-out
power supply |
| Maximum Power
Consumption | 80W | 80W | Same |
| | | | In comparison with |
| Power save
mode | Less than 1W | Less than 5W | predicate device,
UMD3-21B01
(MD3-21B01)
consumes less
power in power
save mode. |
| Power
Management | DVI DMPM,
DisplayPort 1.2a | DVI DMPM,
DisplayPort 1.2 | Same |
| Quality-control
Software | AcuCal | Beacon Monitor
Manage | Different design
scheme |
| | Backlight sensor
Integrated front sensor
Ambient light sensor | Backlight sensor
Integrated front sensor
Ambient light sensor | |
| Sensors | Same | | |
| Luminance
calibration tools | -Integrated optical
sensor
-External optical sensor
-Calibration software:
AcuCal-Pro | -Integrated optical sensor
-External optical sensor
-Calibration software:
Beacon Monitor Manage | Different design
scheme |
| USB Ports | 1 upstream, 3
downstream / Rev. 2.0 | Upstream
USB 2.0: Type-B x 1 | In comparison with
predicate device,
UMD3-21B01
(MD3-21B01)
has one more
downstream USB
Port for service use |
| Brightness
stabilization | Yes | Yes | Same |
| Digital uniformity
equalizer | Yes | Yes | Same |
| Net weight | 10.9 kgs | 9.5 kgs | Different industrial
design |
| Hole Spacing
(VESA Standard) | 100 x 100mm | 100 x 100mm | Same |
| Dimensions
w/o Stand
(W x H x D) | 354.2 x 472.7 x 78.8
mm | 369 x 220 x 511.5 ~
596.15 mm | Different industrial
design |
6
7
8
According to the above table, UMD3-21B01 (MD3-21B01) 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.
VII. PERFORMANCE DATA
The performance tests below were performed on the UMD3-21B01 (MD3-21B01) 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 ● UMD3-21B01 (MD3-21B01) 510(k) Submission
9
guideline
- Measurement of the angular dependency of luminance response in horizontal, vertical and diagonal directions
- Measurement of the chromaticity non-uniformity characteristics of the display screen as specified in TG18 guideline
XIII. CONCLUSIONS
After analyzing all testing data and comparing it with the predicated device, it can be concluded that UMD3-21B01 (MD3-21B01) is substantially equivalent to the predicate device (K201211) with respect to technological characteristic, application and intended use. Some of the technological characteristics of UMD3-21B01 (MD3-21B01) are different from the predicate device, but they do not affect the safety and effectiveness, so no new risk is raised.
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.