(21 days)
Not Found
No
The description focuses solely on the hardware specifications and features of a medical display, with no mention of AI or ML capabilities for image analysis or processing beyond basic display functions.
No
The device is an LCD display intended for viewing digital medical images for review and analysis by trained medical practitioners. It does not exert any therapeutic action on a patient.
No
This device is an LCD display used to show digital images for review and analysis by medical practitioners. It does not perform any diagnostic function itself but is a tool used in the diagnostic process.
No
The device description explicitly states it is an "LCD display," which is a hardware component. The intended use is for displaying and viewing digital images on this physical display.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to display and view digital images for review and analysis by medical practitioners. This is a function related to medical imaging, not the analysis of biological samples or substances from the human body.
- Device Description: The description focuses on the technical specifications of an LCD display for viewing images. It doesn't mention any components or processes related to analyzing biological materials.
- Mentions image processing: While it mentions "image processing," this is in the context of radiological systems, which are used to generate images of the body, not to analyze biological samples.
- Input Imaging Modality: The input is "digital images," which are visual representations, not biological samples.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is to display images generated by other medical equipment, not to perform analysis on biological samples.
N/A
Intended Use / Indications for Use
The D-VIEW 3MP (X213C3P0E, X213G3P0E) and 2MP (X213C2P0E) LCD Display is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
Product codes
PGY
Device Description
LCD display is a display system for medical viewing, with high resolution 1600 x 1200(X213C2P0E , X213G2P0E) and 2048 x 1536 (X213C3P0E , X213G3P0E), built-in brightness stabilization circuit, front sensor and ambient light sensor, stable brightness and persistent calibration can be guaranteed. These displays can support both landscape and portrait mode. The anti-reflection coated protective screen can prevent display from damage under hard using conditions, make the clean and disinfect easier.
Mentions image processing
Yes
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, composed of three overlapping shapes that resemble a person's head, torso, and legs. The figure is oriented to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 28, 2015
D-VIEW Display Technology Co., Ltd. % Mr. Jianfei Sun Regulatory Manager 3F, Building 4, No.12# Kechuang 13th Street, BDA area Beijing 100176 CHINA
Re: K151854 Trade/Device Name: 3MP (X213C3P0E, X213G3P0E) and 2MP (X213C2P0E, X213G2P0E) LCD display Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: July 3, 2015 Received: July 7, 2015
Dear Mr. Sun:
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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D'Hara
For
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K151854
Device Name
3MP (X213C3P0E、X213G3P0E) and 2MP (X213C2P0E、X213G2P0E) LCD display
Indications for Use (Describe)
The D-VIEW 3MP (X213C3P0E, X213G3P0E) and 2MP (X213C2P0E) LCD Display is intended to be used in 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) | |
|---|---|
| ------------------------------------------------- | -- |
| Prescription Use (Part 21 CFR 201 Subpart D) | Over-The-Counter Use (21 CFR 201 Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------- |
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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3
510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
July 3, 2015
2. Submitter's Information [21 CFR807.92 (a) (1)]
| Name of Sponsor: | D-VIEW Display Technology Co.,Ltd. | |
|---|---|---|
| Address: | 3F, Building 4, No.12# Kechuang 13th Street , BDA area, Beijing, | |
| P.R.China | ||
| Contact Name: | Jianfei Sun | |
| Telephone No.: | +8610 82379533 EXT. 5360 | |
| Fax No.: | +8610 82379511 | |
| Email Address: | sunjianfei@d-view.cn |
3. Trade Name, Common Name, Classification [21 CFR807.92 (a) (2)]
| Trade Name: | D-VIEW |
|---|---|
| Common Name: | 3MP (X213C3P0E X213G3P0E) and 2MP (X213C2P0E X213G2P0E) LCD display |
| Classification: | 892.2050 system, image processing, radiological |
| Product code: | PGY |
| Classification Panel: | Radiology |
| Device Class: | II |
4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
The identified predicates within this submission are as follows: BARCO N.V., Coronis 3MP(MDCG-3221) has been cleared by FDA through 510(k)
4
No.K131246 (Decision Date -May 24, 2013), Classification: 892.2050 system, image processing, radiological Product code: LLZ Device Class: II
5. Description of the Device [21 CFR 807.92(a) (4)]
LCD display is a display system for medical viewing, with high resolution 1600 x 1200(X213C2P0E , X213G2P0E) and 2048 x 1536 (X213C3P0E , X213G3P0E), built-in brightness stabilization circuit, front sensor and ambient light sensor, stable brightness and persistent calibration can be guaranteed. These displays can support both landscape and portrait mode. The anti-reflection coated protective screen can prevent display from damage under hard using conditions, make the clean and disinfect easier.
6. Intended Use [21 CFR 807.92(a)(5)]
The D-VIEW 3MP (X213C3P0E,X213G3P0E) and 2MP (X213C2P0E,X213G2P0E) LCD Display is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
| Panel | 21.3", TFT monochrome LCD screen, antiglare |
|---|---|
| Brightness (typ.) | 1900cd/m2 (2MP: X213G2P0E) |
| 900cd/m2 (2MP: X213C2P0E) | |
| 1700cd/m2 (3MP: X213G3P0E) | |
| 800cd/m2 (3MP: X213C3P0E) | |
| CR (typ.) | 1400:1 |
| Viewing angle | R/L 176°, U/D 176° Typ. ( CR ≥ 10 ) |
| Pixel Pitch | 0.2115 × 0.0705mm ( 3MP ) |
| 0.270 × 0.270mm ( 2MP ) | |
| Native resolution | 2048 x 1536 (3MP) |
| 1600 x 1200 (2MP) | |
| Display area | 433(V)mm × 324 mm(H) |
| Compatible video signals | 3MP: |
| 640 x 480@60Hz(progressive) | |
| 2048x1536@60Hz(progressive) | |
| 2MP: |
5
| 640 x 480@60Hz(progressive) | |
|---|---|
| 1600x1200@60Hz(progressive) | |
| Horizontal resolution | 3MP: 2048x1536@60Hz(progressive) |
| 2MP: 1600x1200@60Hz(progressive) | |
| Bandwidth | 3MP: 267MHz |
| 2MP: 162MHz | |
| Aspect ratio | 4:3 |
| Screen size | 21.3" real diagonal |
| Power | 3MP, X213C3P0E: DC12V 3.5A |
| 3MP, X213G3P0E: DC12V 2.2A | |
| 2MP, X213C2P0E: DC12V 3.5A | |
| 2MP, X213G2P0E: DC12V 2.2A | |
| Input signals | DVI-I, DP |
| Digital input | TMDS ( dual ) |
| Dimension | 375 mm (W) x 434mm (H) x 70mm (D) ( without Stand ) |
| 375 mm (W) x 589 mm (H) x 173mm (D) ( with Stand ) | |
| Weight | 7.0±0.3kg ( without Stand ) |
| 10.5kg±0.3kg ( with Stand ) | |
| Operating | |
| Atmospheric | |
| Pressure | 70kPa ~ 106kPa |
| Operating | |
| temperature and | |
| humidity: | Temperature: 0℃~40℃ |
| Humidity: 30% ~75% | |
| Storage | |
| temperature and | |
| humidity: | Temperature: -20°C ~ 60°C |
| Humidity: 0% ~90% |
8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
8.1 Intended uses:
Table 1 Intended Use Comparison
| ID | Comparison Item | Proposed Device | Predicate Device |
|---|---|---|---|
| D-VIEW 3MP (X213C3P0E, | |||
| X213G3P0E) and 2MP | |||
| (X213C2P0E, X213G2P0E) | Coronis 3MP(MDCG-3221) |
6
| 1 | Intended
Use | The D-VIEW 3MP
(X213C3P0E, X213G3P0E)
and 2MP (X213C2P0E,
X213G2P0E) LCD Display is
intended to be used in
displaying and viewing digital
images (excluding digital
mammography) for review and
analysis by trained medical
practitioners. | "The Coronis 3MP
(MDCG-3221)" is intended to
be used as a tool in displaying
and viewing digital images
(excluding digital
mammography) for review and
analysis by trained medical
practitioners. |
| --- | ----------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
8.2 Comparison table
| ID | Comparison
Item | Proposed Device
D-VIEW 3MP (X213C3P0E,
X213G3P0E) and 2MP
(X213C2P0E, X213G2P0E) | Predicate Device
Coronis 3MP(MDCG-3221) |
|-----|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| 2 | Performance | | |
| 2.1 | Panel Size and Type | 21.3", TFT LCD display | 21.3",TFT LCD display |
| 2.2 | Pixel Pitch | 0.2115 × 0.0705mm (3MP)
0.270 × 0.270mm(2MP) | 0.2115 mm |
| 2.3 | Available Cabinet
Colors | Black | Black |
| 2.4 | Native Resolutions | 1600 x 1200 (2MP)
2048 x 1536 (3MP) | 2048 x1536 |
| 2.5 | Brightness | 1900cd/m2 (2MP,
X213G2P0E)
900cd/m2 (2MP,
X213C2P0E)
1700cd/m2 (3MP,
X213G3P0E)
800cd/m2 (3MP,
X213C3P0E) | 1700 cd/m2 |
| 2.6 | Contrast Ratio | 1400:1 | 1300:1 |
| 2.7 | Network Interface | USB(1 Up, 2 Downstream) | USB(1 Up, 2 Downstream) |
| 2.8 | Active Display Size | 433mm × 324 mm | 433.2mm x 324.9mm |
| 3 | Physical Specifications | | |
| 3.1 | Dimensions
(Wx Hx D) | 375 mm (W) x 434mm (H) x
70mm (D) ( without Stand ) | 375mm x 488mm x 84mm
(without Stand) |
| ID | Comparison Item | Proposed Device
D-VIEW 3MP (X213C3P0E,
X213G3P0E) and 2MP
(X213C2P0E, X213G2P0E) | Predicate Device
Coronis 3MP(MDCG-3221) |
| | | 375 mm (W) x 589 mm (H) x
173mm (D) (with Stand) | Portrait:
375mm x 620520mm463mm
x 235mm
Landscape:
488mm x 563
x 250mm
(with Stand) |
| | | | |
| | | | |
| | Temperature | | |
| 3.2 | Operating | 0°C ~ 40°C | 0°C ~ 40°C |
| 3.3 | Transport/ Storage | -20°C ~ 60°C | -20°C ~ 60°C |
| | Relative humidity | | |
| 3.4 | Operating | 30% ~75%(non-condensing) | 8% ~80%(non-condensing) |
| 3.5 | Transport/ Storage | 0% ~90% | 5% ~95% |
| 4 | | Power Supply | |
| 4.1 | PowerCapacity |