(56 days)
Not Found
No
The document describes a medical display monitor with features for image viewing and stabilization, but there is no mention of AI or ML technology being used for image analysis, processing, or any other function.
No.
The device is a monitor intended for displaying and viewing digital images for review and analysis, not for providing therapy or treatment.
No
The device is a medical monitor designed for displaying medical images, not for performing a diagnostic function itself. It assists in diagnosis by providing a viewing platform for images, but it does not analyze or interpret the images to reach a diagnosis.
No
The device description clearly states it is a "display system" and lists hardware components like an LCD monitor, brightness stabilization circuit, and sensors.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "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 to diagnose conditions.
- Device Description: The description focuses on the technical specifications of a display monitor (resolution, brightness, sensors, screen type). This aligns with a medical imaging display, not an IVD device which would typically involve reagents, assays, or analytical components.
- Mentions image processing: While it mentions "image processing," this is in the context of a radiological system, which is consistent with displaying medical images. IVD devices perform analytical processing of biological samples.
- Lack of IVD characteristics: There is no mention of analyzing biological samples, performing tests, or providing diagnostic results based on laboratory analysis.
Therefore, this device is a medical imaging display monitor, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 2MP/3MP LCD Monitor (HMD2C21) is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
Product codes (comma separated list FDA assigned to the subject device)
PGY
Device Description
The 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) is a display system for medical viewing, with high resolution 1600x1200(HMD2C21)/2048 x 1536(HMD3C21), 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
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The electrical, mechanical and thermal safety evaluation is conducted as per the requirements of the standard IEC 60601-1.
Complying with IEC 60601-1-2 for EMC Evaluation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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).
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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.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 16, 2015
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 P.R. CHINA
Re: K152030
Trade/Device Name: Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: July 7, 2015 Received: July 22, 2015
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/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,
Robert Ochs
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152030
Device Name
Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21)
Indications for Use (Describe)
The 2MP/3MP LCD Monitor (HMD2C21) 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) |
|---|
| ------------------------------------------------- |
| ☒ Residential Use (Rentals of 30+ Consecutive Days) |
|---|
| ☐ Care/Elderly Services Use (Rentals of 30+ Consecutive Days) |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
Jul 8th, 2015
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 HMD2C21/ HMD3C21 |
|---|---|
| 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., Coronis 3MP (MDCG-3221) has been cleared by FDA through 510(k) No.K131246 (Decision Date --May 24, 2013), BARCO N.V., Nio 2MP (MDNC-2221) has been cleared by FDA through 510(k) No
510(k) Summary
K133663 (Decision Date -03/25/2014)
4
5. Description of the Device [21 CFR 807.92(a) (4)]
The 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) is a display system for medical viewing, with high resolution 1600x1200(HMD2C21)/2048 x 1536(HMD3C21), 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 (HMD2C21/HMD3C21) 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)]
| The HMD3C21 | |
|---|---|
| Panel | 21.2", TFT color LCD screen, antiglare |
| Brightness (typ.) | 900 cd/m² |
| CR (typ.) | 1400:1 |
| Viewing angle | R/L 176°, U/D 176° Typ. (CR > 10) |
| Pixel Pitch | 0.21075 mm |
| Native resolution | 2048 x 1536 |
| Display area | 431.6mm(H)x323.7mm (V) |
| Compatible video signals | 640 x 480@60Hz(progressive) |
| 2048x1536@60Hz (progressive) | |
| Horizontal resolution | 2048 x 1536 |
| Aspect ratio | 4:3 |
| Screen size | 21.2" real diagonal |
| Power | DC24V/3.5A |
| Power consumption | Max. 80 W |
| Input signals | DVI-D, Display Port |
| Digital input | TMDS (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 |
The HMD3C21
5
| Stand ) | |
|---|---|
| Weight | 6.1kg (without Stand ) |
| 10.4kg (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 HMD2C21
| The HMD2C21 | |
|---|---|
| Panel | 21.3", TFT color LCD screen, antiglare |
| Brightness (typ.) | 770 cd/m² |
| CR (typ.) | 1100:1 |
| 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) |
| 1600 x 1200@60Hz (progressive) | |
| Horizontal resolution | 1600 x 1200 |
| Aspect ratio | 4:3 |
| Screen size | 21.3" real diagonal |
| Power | DC24V/3.0A |
| Power consumption | Max. 70 W |
| Input signals | DVI-D, Display Port |
| Digital input | TMDS (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 | 6.1kg (without Stand) |
| 10.4kg (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% |
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8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
8.1 Intended uses:
| ID | Comparison Item | Proposed Device
3MP LCD Monitor(HMD3C21) | Predicate Device
Nio 3MP(MDNC-3221) |
|----|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Intended Use | The HMD3C21 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 (MDNC-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. |
Table 1 Intended Use Comparison of HMD3C21
Table 2 Intended Use Comparison of HMD2C21
| ID | Comparison Item | Proposed Device
2MP LCD Monitor(HMD2C21) | Predicate Device
Nio 2MP(MDNC-2221) |
|----|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Intended Use | The HMD2C21 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 (MDNC-2221)" 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. |
8.2 Comparison table
Table 3 General Comparison about HMD3C21 and Nio 3MP
| ID | Comparison
Item | Proposed Device
3MP LCD Monitor
(HMD3C21) | Predicate Device
Nio 3MP(MDNC-3221) |
|-----|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2 | Performance | | |
| 2.1 | Panel Size and Type | 21.2", TFT LCD display | 21.3",TFT LCD display |
| 2.2 | Pixel Pitch | 0.21075 mm | 0.2115 mm |
| 2.3 | Available Cabinet
Colors | Red , Green , Blue | Red , Green , Blue |
| ID | Comparison Item | Proposed Device
3MP LCD Monitor
(HMD3C21) | Predicate Device
Nio 3MP(MDNC-3221) |
| 2.4 | Native Resolutions | 2048 x1536 | 2048 x1536 |
| 2.5 | Brightness | 900 cd/m2 | 800 cd/m2 |
| 2.6 | Contrast Ratio | 1400:1 | 1400:1 |
| 2.7 | Network Interface | USB(1 Up, 2 Downstream) | USB(1 Up, 2 Downstream) |
| 2.8 | Active Display Size | 431.616mm x 323.712mm | 433.2mm x 324.9mm |
| 3 | Physical Specifications | | |
| 3.1 | Dimensions
(Wx Hx D) | 384.0mm (W) x 492.0mm
(H) x 70.0mm (D) (without
Stand )
384.0 mm (W) x
517.5-637.5 mm (H) x
273.5mm (D) (with Stand) | 375mm x 488mm x 84mm
(without 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 | 20% ~80% | 8% ~80%(non-condensing) |
| 3.5 | Transport/ Storage | 10% ~90% | 5% ~95% |
| 4 | Power Supply | | |
| 4.1 | Power Capacity |