(24 days)
Not Found
No
The device description and intended use focus solely on the display capabilities of a medical monitor. There is no mention of AI, ML, or any related image analysis or processing beyond basic display functions.
No
The device is a monitor intended for displaying and viewing digital images for review and analysis, which is a diagnostic function, not a therapeutic one.
Yes
Explanation: The device is intended for "displaying and viewing digital images ... for review and analysis by trained medical practitioners," which directly supports clinical diagnostic processes.
No
The device description explicitly details hardware components like the LCD monitor, brightness stabilization circuit, front sensor, and ambient light sensor. It is a physical display system, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "displaying and viewing digital images" for "review and analysis by trained medical practitioners." This describes a device used for visualizing medical images, not for performing tests on biological samples (which is the core function of an IVD).
- Device Description: The description focuses on the technical specifications of a display system (resolution, brightness stabilization, sensors, screen type). It does not mention any components or processes related to analyzing biological samples.
- Regulation Number: The mention of "892.2050 system, image processing, radiological" points to a classification related to radiology and medical imaging systems, not IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other elements typically associated with IVD devices.
In summary, this device is a medical display monitor used for viewing radiological images, which falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The 2MP/3MP LCD Monitor (HMD2G21) is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The 5MP LCD Monitor (HMD5G21) is intended to be used in displaying digital images for review and analysis by trained medical practitioners, including digital mammography.
Product codes (comma separated list FDA assigned to the subject device)
PGY
Device Description
The 2MP/3MP/5MP LCD Monitor (HMD2G21/HMD3G21) is a display system for medical viewing, with high resolution 1600x1200(HMD2G21)/2048 x 1536(HMD3G21)/ 2560 x 2048(HMD5G21), built-in brightness stabilization circuit, front sensor and ambient light sensor, stable brightness and persistent calibration can be guaranteed. The display can support both landscape and portrait mode. The antiglare screen can prevent display from reflection under highlight conditions, make the image and display clearer.
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)
Not Found
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
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, with three overlapping faces suggesting a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure, emphasizing the organization's name and national affiliation.
March 3, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Qingdao Hisense Medical Equipment Co.,Ltd. % Mr. Liu Zhitang Regulatory Manager Software outsourcing center 3rd floor north wing No.169 Songling Road, Laoshan Qing dao, Shan dong 266101 CHINA
Re: K160347
Trade/Device Name: Hisense LCD monitor models HMD2G21/HMD3G21/HMD5G21 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: February 2, 2016 Received: February 8, 2016
Dear Mr. Zhitang:
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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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/ResourcesforYou/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. 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)
Device Name
Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21
Indications for Use (Describe)
The 2MP/3MP LCD Monitor (HMD2G21) is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The 5MP LCD Monitor (HMD5G21) is intended to be used in displaying digital images for review and analysis by trained medical practitioners, including digital 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) |
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 PRAStaff@fda.hhs.gov
"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."
3
510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
Jan 8", 2016
2. Submitter's Information [21 CFR807.92 (a) (1)]
| Name of Sponsor: | Qingdao Hisense Medical Equipment Co., Ltd. |
|---|---|
| Address: | Software outsourcing center 3rd floor north wing, No.169 |
| Songling Road, Laoshan Dist. 266101, Qingdao, China | |
| Contact Name: | Liu Zhitang |
| Telephone No .: | +86 ( 0 ) 532-55753811 |
3. Trade Name, Common Name, Classification [21 CFR807.92 (a) (2)]
| Trade Name: | Hisense LCD monitor models HMD2G21/ HMD3G21/
HMD5G21 | | | |
|-----------------------|---------------------------------------------------------|--|--|--|
| Common Name: | Display system, medical image workstation, and others | | | |
| 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., Nio 2MP(MDNG-2121) has been cleared by FDA through 510(k) No. K091172, BARCO N.V., Nio 3MP(MDCG-3221) has been cleared by FDA through 510(k) No . K131246 BARCO N.V., Nio 5MP(MDNG-5121) has been cleared by FDA through 510(k) No . K062131
4
5. Description of the Device [21 CFR 807.92(a) (4)]
The 2MP/3MP/5MP LCD Monitor (HMD2G21/HMD3G21) is a display system for medical viewing, with high resolution 1600x1200(HMD2G21)/2048 x 1536(HMD3G21)/ 2560 x 2048(HMD5G21), built-in brightness stabilization circuit, front sensor and ambient light sensor, stable brightness and persistent calibration can be guaranteed. The display can support both landscape and portrait mode. The antiglare screen can prevent display from reflection under highlight conditions, make the image and display clearer.
6. Intended Use [21 CFR 807.92(a)(5)]
The 2MP/3MP LCD Monitor (HMD2G21/HMD3G21) are intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The 5MP LCD Monitor (HMD5G21) is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners, including digital mammography.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
| Panel | 21.3", a-Si TFT LCD, antiglare |
|---|---|
| Brightness (typ.) | 1900 cd/m² |
| CR (typ.) | 1400:1 |
| Viewing angle | R/L 176° , U/D 176° Typ. (CR > 10) |
| Pixel Pitch | 0.27 mm |
| Native resolution | 1600 x 1200 |
| Display area | 432.0mm(H)x324.0mm (V) |
| Compatible video signals | 640 x 480@60Hz(progressive) |
| 1024 x 768@60Hz(progressive) | |
| 1600x1200@60Hz (progressive) | |
| Aspect ratio | 4:3 |
| Screen size | 21.3" real diagonal |
| Power | DC24V/2.2A |
| Power consumption | Max. 60 W |
| Input signals | DVI-D, Display Port |
The HMD2G21
5
| Digital input | LVDS (single) |
|---|---|
| Plug and play | VESA DDC 2B |
| Dimension | 384.0mm (W) x 492.0mm (H) x70.0mm (D) (without Stand) |
| 384.0 mm (W) x 637.5 mm (H) x 273.5mm (D) (with Stand) | |
| Weight | 5.5kg (without Stand) |
| 9.9kg (with Stand) | |
| Operating | |
| temperature and | |
| humidity: | Temperature: 0°C ~ 40°C |
| Humidity: 20% ~80% | |
| Storage | |
| temperature and | |
| humidity: | Temperature: -20°C ~ 60°C |
| Humidity:10% ~90% | |
The HMD3G21
| Panel | 21.2", IPS-NEO, antiglare |
|---|---|
| Brightness (typ.) | 1700 cd/m² |
| CR (typ.) | 1400:1 |
| Viewing angle | R/L 176° , U/D 176° |
| Typ. (CR > 10) | |
| Pixel Pitch | 0.21075 mm |
| Native resolution | 2048x1536 |
| Display area | (H)431.6x(V)323.7(mm) |
| Compatible video | |
| signals | 640 x 480@60Hz(progressive) |
| 2048x1536@60Hz (progressive) | |
| Aspect ratio | 4:3 |
| Screen size | 21.2" real diagonal |
| Power | DC24V/2.2A |
| Power consumption | Max. 60 W |
| Input signals | DVI-D, Display Port |
| Digital input | LVDS (single) |
| Plug and play | VESA DDC 2B |
| Dimension | 384.0mm (W) x 492.0mm (H) x 70.0mm (D) (without |
| Stand) | |
| 384.0 mm (W) x 637.5 mm (H) x 273.5mm (D) (with | |
| Stand) | |
| Weight | 6.1kg (without Stand) |
| 10.4kg (with Stand) | |
| Operating | |
| temperature and | |
| humidity: | Temperature: 0°C ~ 40°C |
| Humidity: 20% ~80% | |
| Storage | Temperature: -20°C ~ 60°C |
6
| temperature and
| humidity: | Humidity: 10% ~ 90% |
|---|---|
| ------------------------------ | --------------------- |
The HMD5G21
| Panel | 21.3", IPS-NEO, antiglare |
|---|---|
| Brightness (typ.) | 1200 cd/m² |
| CR (typ.) | 1200:1 |
| Viewing angle | R/L 176° , U/D 176° Typ. (CR > 50) |
| Pixel Pitch | 0.165 mm |
| Native resolution | 2560 x 2048 |
| Display area | 422.4mm(H)x337.9mm (V) |
| Compatible video signals | 640 x 480@60Hz(progressive) |
| 1024 x 768@60Hz(progressive) | |
| 2560 x 2048@60Hz (progressive) | |
| Aspect ratio | 5:4 |
| Screen size | 21.3" real diagonal |
| Power | DC24V/3A |
| Power consumption | Max. 72 W |
| Input signals | DVI-D, Display Port |
| Digital input | LVDS (double) |
| Plug and play | VESA DDC 2B |
| Dimension | 392.0mm (W) x 498.0mm (H) x83.0mm (D) (without Stand) |
| 392.0 mm (W) x 632.0 mm (H) x 273.5mm (D) (with Stand) | |
| Weight | 8.5kg (without Stand) |
| 12.8kg (with Stand) | |
| Operating temperature and humidity: | Temperature: 0°C ~ 40°C |
| Humidity: 20%~80% | |
| Storage temperature and humidity: | Temperature: -20°C ~ 60°C |
| Humidity: 10% ~90% |
8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
8.1 Intended uses:
Table 1 Intended Use Comparison of HMD2G21
| ID | Comparison Item | Proposed Device
2MP LCD Monitor (HMD2G21) | Predicate Device
Nio 2MP(MDNG-2121) |
| ---- | ----------------- | ---------------------------------------------- | ---------------------------------------- |
|---|
7
| 1 | Intended
Use | The HISENSE 2MP LCD
Monitor (HMD2G21) is intended
to be used in displaying and
viewing digital images (excluding
digital mammography) for review
and analysis by trained medical
practitioners. | The Nio 2MP(MDNG-2121)
is intended to be used in
displaying and viewing digital
images for review by trained
medical practitioners. These
devices must not be used in
primary image diagnosis in
mammography. |
| --- | ----------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
Table 2 Intended Use Comparison of HMD3G21
| ID | Comparison
Item | Proposed Device
3MP LCD Monitor (HMD3G21) | Predicate Device
Nio 3MP(MDCG-3221) |
|----|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Intended
Use | The HISENSE 3MP LCD
Monitor ( HMD3G21) is intended
to be used in displaying and
viewing digital images (excluding
digital mammography) for review
and analysis by trained medical
practitioners. | The Nio 3MP(MDCG-3221) is
intended to be used in displaying
and viewing digital images for
review by trained medical
practitioners. These devices
must not be used in primary
image diagnosis in
mammography. |
Table 3 Intended Use Comparison of HMD5G21
| ID | Comparison
Item | Proposed Device
5MP LCD Monitor (HMD5G21) | Predicate Device
Nio 5MP(MDNG-5121) |
|----|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Intended
Use | The 5MP LCD Display
(HMD5G21) is intended to be
used in displaying and viewing
digital images for review and
analysis by trained medical
practitioners, including digital
mammography. | The Nio 5MP(MDNG-5121) is
intended to be used as a tool in
displaying and viewing digital
images for review and analysis
by trained medical practitioners,
including digital mammography. |
8.2 Comparison table
Table 4 General Comparison about HMD2G21 and Nio 2MP
| ID | Comparison
Item | Proposed Device
HMD2G21 | Predicate Device
Nio 2MP(MDNG-2121) |
|-----|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2 | Performance | | |
| 2.1 | Panel Size and Type | 21.3", TFT LCD display | 21.3", TFT LCD display |
| 2.2 | Pixel Pitch | 0.27 mm | 0.27 mm |
| ID | Comparison
Item | Proposed Device
HMD2G21 | Predicate Device
Nio 2MP(MDNG-2121) |
| 2.3 | Native Resolutions | 1600x1200 | 1600x1200 |
| 2.4 | Brightness | 1900 cd/m2 | 1650 cd/m2 |
| 2.5 | Contrast Ratio | 1400:1 | 850:1 |
| 2.6 | Network Interface | USB(1 Up, 2 Downstream) | USB(1 Up, 2 Downstream) |
| 2.7 | Active Display Size
(HxV) | 432.0mm x324.0mm | 432mm x324mm |
| 3 | Physical Specifications | | |
| 3.1 | Dimensions
(Wx Hx D) | 384mm (W) x 492mm (H) x
70mm (D) (without Stand)
384 mm (W) x 517.5-637.5
mm (H) x 273.5mm (D) (with
Stand) | 382x 488 x 114 mm (without
Stand)
Portrait:
382 x 577637 x 249 mm532 x 249 mm
Landscape:
488 x 472
(with Stand) |
| | Temperature | | |
| 3.2 | Operating | 0°C ~ 40°C | 0°C ~ 35°C |
| 3.3 | Transport/ Storage | -20°C ~ 60°C | -20°C ~ 60°C |
| | Relative humidity | | |
| 3.4 | Operating | 20% ~80% | 8% ~80%(non-condensing) |
| 3.5 | Transport/ Storage | 10% ~90% | 5% ~85% |
| 4 | Power Supply | | |
| 4.1 | PowerCapacity | ≤60W |